presentation of xanax

Alprazolam (Oral Route)

Drug information provided by: Merative, Micromedex ®

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is used for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the extended-release tablet or tablet whole with a full glass of water. Do not break, crush, or chew it.

If you are using the orally disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not remove the tablets from the bottle until you are ready to take it. Place the tablet immediately on the top of your tongue. It should melt quickly and be swallowed with saliva.

If you are using the oral liquid, measure the dose with a marked measuring spoon, oral syringe, or medicine cup.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Adults—At first, 0.25 to 0.5 milligram (mg) 3 times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 4 mg per day.
Older adults—At first, 0.25 mg 2 or 3 times a day. Your doctor may increase your dose as needed.
Children—Use and dose must be determined by your doctor.
Adults—At first, 0.5 to 1 milligram (mg) taken in the morning once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 10 mg per day.
Older adults—At first, 0.5 mg taken in the morning once a day. Your doctor may increase your dose as needed.
Adults—At first, 0.5 milligram (mg) 3 times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 10 mg per day.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is very important to protect the orally disintegrating tablets from moisture. Remove and throw away any cotton packaging from the medicine bottle when you first use the medicine.

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NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.

StatPearls [Internet].

Tobin T. George ; Jayson Tripp .

Affiliations

Last Update: April 24, 2023 .

Continuing Education Activity

Alprazolam, known by various trade names, is the most commonly prescribed psychotropic medication in the United States. Alprazolam is frequently prescribed to manage panic and anxiety disorders. Alprazolam has also been misused for recreational purposes because of its disinhibition, euphoria, and anxiolytic effects. FDA-labeled indications include anxiety disorders and panic disorders with or without agoraphobia. This activity outlines the indications, mechanism of action, administration, dosing, contraindications, warnings, precautions, adverse drug reactions, and toxicity of alprazolam in the clinical setting as relates to the essential points needed by members of an interprofessional team managing the care of patients with mental health disorders.

Identify the mechanism of action of benzodiazepines, including alprazolam.
Review the adverse effects of alprazolam to identify the signs of benzodiazepine toxicity.
Explain the proper indications for alprazolam therapy.
Outline the importance of collaboration and coordination among the interprofessional team and how it can enhance patient care when dosing alprazolam to improve patient outcomes for patients.
Indications

FDA-labeled Indications [2]

Anxiety disorders- generalized anxiety disorder
Panic disorders- with or without agoraphobia

Non-FDA-labeled Indications [2]

Premenstrual syndrome
Mechanism of Action

Alprazolam belongs to a class of psychoactive medications called benzodiazepines. Benzodiazepines bind to the GABA-A receptor. This receptor is comprised of five subunits, e.g., alpha, beta, gamma, delta, epsilon, rho, etc. A common GABA-A receptor in the CNS is comprised of two alpha-1 subunits, two beta-2 subunits, and one gamma-2 subunit. The benzodiazepine binding site is between the alpha-1 and gamma-2 subunits. Studies in mice suggest that the alpha-1 subunit mediates sedation, amnesia, and ataxic effects of benzodiazepines, and alpha-2 and alpha-3 subunits mediate anxiolytic and muscle-relaxing effects of benzodiazepines. Also, research suggests that BNZ-1 receptors affect sedation and anti-anxiety, while the BNZ-2 affects muscle relaxation, anticonvulsant activity, memory, and motor coordination. Benzodiazepine binding sites appear to exhibit coupling with GABA-A receptors, enhancing the effects of gamma-aminobutyric acid (GABA) by increasing GABA affinity at the GABA-A receptor. When bound to the GABA-A receptor, the major inhibitory neurotransmitter GABA mediates the calming or inhibitory effects of alprazolam on the human nervous system. [3] [4]

Pharmacokinetics

Alprazolam is rapidly absorbed after oral administration with a peak plasma concentration at 1 to 2 hours. The bioavailability of oral alprazolam averages 80 to 100%.

Distribution

Alprazolam is 80% bound to serum protein, mainly albumin.

Alprazolam is metabolized in the liver by cytochrome P450 3A4 (CYP3A4) to 4-hydroxyalprazolam and alpha-hydroxyalprazolam metabolites.

Alprazolam and its metabolites are filtered out by the kidneys and excreted in the urine. The mean plasma half-life of alprazolam is about 11.2 hours in healthy adults.

Administration

Alprazolam is available as a regular release and orally disintegrating tablets in strengths of 0.25 mg, 0.5 mg, 1 mg, and 2 mg tablets, while extended-release tablets are available in strengths of 0.5 mg, 1 mg, 2 mg, and 3 mg. Alprazolam is also available as an oral solution in strengths of 0.5 mg/5 mL and 1 mg/10 mL. Administration of alprazolam may be without regard to food. Take with food if the patient experiences an upset stomach. The orally disintegrating tablets must remain in their original packaging and must not be put in a pillbox. The extended-release tablets are not to be chewed, crushed, or split but instead swallowed whole. Alprazolam is a controlled substance with the C-IV designation. [5] [6]

Treatment of Anxiety Disorders

Oral dosage forms (immediate-release tablets, orally disintegrating tablets, and solution):

Adult Dosage

0.25 mg to 0.5 mg three times a day
Dosage increases should occur at intervals of 3 to 4 days with increments of no more than 1 mg per day.
Maximum dose: 4 mg/day

Geriatric Dosage

0.25 mg two or three times a day.

Treatment of Panic Disorders

Oral Dosage form (extended-release tablets):

0.5 to 1 mg once a day
Maintenance dose: 3 to 6 mg orally per day
Maximum dose: 10 mg/day

Geriatric Dosage

0.5 mg orally once a day

Oral Dosage forms (immediate-release tablets, orally disintegrating tablets, solution):

0.5 mg three times a day
0.25 mg two or three times a day

Pediatric Considerations

The safety and effectiveness of alprazolam are not being established in pediatric patients.

Hepatic Impairment Dose Adjustments

Oral dosage forms (immediate-release tablets/orally disintegrating tablets): 0.25 mg orally two or three times daily

Oral dosage forms (extended-release tablets): 0.5 mg orally once a day

Debilitating Disease Dose Adjustments

Dose Reduction

As a result of the danger of withdrawal, avoid abrupt discontinuation of treatment. The dosage should be gradually reduced in all patients when discontinuing therapy or decreasing the daily dosage. The suggested method is that the daily dosage reduction is not more than 0.5 mg every three days, and some patients may require an even slower dosage reduction. In patients with long-term chronic alprazolam use, one should switch to a longer-acting benzodiazepine such as clonazepam or diazepam and titrate down gradually; this results in fewer withdrawal side effects. [7]

Pregnancy Considerations

Alprazolam is categorized as pregnancy category D medicine. A pregnancy exposure registry is established to monitor pregnancy outcomes in women exposed to alprazolam when pregnant. Clinicians are encouraged to register their patients by calling the National Pregnancy Registry for Psychiatric Medications.

Maternal exposure to alprazolam in the later trimester of pregnancy may result in sedation (lethargy, respiratory depression, hypotonia) and withdrawal symptoms (irritability, hyperreflexia, restlessness, tremors, feeding difficulties, and inconsolable crying, and) in the neonate. As benzodiazepines can cross the placenta, clinicians should observe newborns for signs/symptoms of sedation, respiratory depression, feeding problems, and neonatal withdrawal syndrome and manage them appropriately. Available data of published observational studies of pregnant women exposed to alprazolam have not related alprazolam-associated risk of miscarriage, major congenital disabilities, or adverse maternal or fetal outcomes.

Breastfeeding Considerations

Limited reports from published literature show the presence of alprazolam in human breast milk. Sedation and withdrawal symptoms are reported in breastfed neonates/infants exposed to alprazolam via breastmilk. The effects of alprazolam on milk production and lactation are unknown. Since there is a potential for serious adverse reactions for breastfed neonates and infants, lactating women are advised against breastfeeding if treated with alprazolam. [8]

Adverse Effects

Common adverse effects for patients taking alprazolam are [9] :

Sleep problems (insomnia)
Memory problems
Poor balance or coordination
Slurred speech
Trouble concentrating
Irritability
Constipation
Increased sweating
Upset stomach
Blurred vision
Appetite or weight changes
Swelling of hands or feet
Muscle weakness
Stuffy nose
Loss of interest in sex
Worsening depression
Decreased mental alertness
Neonatal sedation and withdrawal syndrome
Contraindications

Contraindications to alprazolam include patients with known alprazolam or benzodiazepine hypersensitivity or known allergies to any of its components in the drug dosage form. Alprazolam should be avoided if possible by anyone with pulmonary disease. Using alprazolam with CNS depressants, especially opioids, increases the risk of respiratory depression, low blood pressure, and death. [10]

Drug Interactions

Alprazolam is affected by drugs that inhibit or induce CYP3A4. Drugs that are potent inhibitors of CYP3A may increase plasma concentrations of alprazolam, resulting in increased adverse events. Medications known to impact alprazolam include azole antifungals (ketoconazole), cimetidine, certain anti-depressants (fluoxetine, fluvoxamine, and nefazodone), macrolide antibiotics (clarithromycin), rifamycins (rifampin), St. John’s wort, seizure medications (carbamazepine, phenytoin), antihistamines and muscle relaxants.

Dosage Modifications for Drug Interactions

Alprazolam dose should be reduced to 50% of the recommended dose when a patient is started on ritonavir and alprazolam concomitantly or when ritonavir is administered to a patient using alprazolam. Clinicians can increase the alprazolam dose to the target dose after 10 to 14 days of administering ritonavir and alprazolam concomitantly. There is no need to reduce the alprazolam dose in patients taking ritonavir for 10 to 14 days.

The patient's respiratory and cardiovascular status should undergo monitoring when treated with alprazolam. Patients should also have monitoring for orthostasis, excessive sedation, and a periodic basic metabolic panel. Liver function tests and complete blood counts also require observation during chronic therapy. In addition, patients at risk for substance misuse disorder should require surveillance as alprazolam use can become addictive in patients. Benzodiazepines can cross the placenta, so clinicians should observe newborns for signs/symptoms of sedation, respiratory depression, feeding problems, and neonatal withdrawal syndrome for infants having in-utero exposure to alprazolam.

The continued use of alprazolam, like all benzodiazepines, may lead to clinically significant physical dependence. The risks of withdrawal and dependence increase with chronic treatment using alprazolam for a longer duration and in high daily doses. After long-term treatment, rapid dosage reduction and abrupt discontinuation of alprazolam may precipitate acute withdrawal. Therefore, it is recommended to taper to discontinue alprazolam gradually To reduce the risk of alprazolam withdrawals and reactions, which can be fatal.

In alprazolam overdose cases, respiration, blood pressure, and pulse rate require monitoring. Intravenous fluids are necessary, and an adequate airway should be maintained. Flumazenil, a benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines. [11] [12]

Enhancing Healthcare Team Outcomes

Alprazolam misuse potential comes from its pharmacokinetic properties of a short half-life, rapid absorption, and low lipophilicity. Compared to other benzodiazepines, alprazolam effects may be felt within 30 minutes and last for about 6 hours. Alprazolam, taken in large doses, produces strong depressive effects, which may cause memory loss. Due to alprazolam's many adverse effects, the nurse practitioner, a pharmacist, and the primary care provider must educate the patient on how to use the drug [13] :

Discuss the specific use of alprazolam with the patient as it relates to treatment
Discuss possible adverse effects and immediately report signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), severe fatigue, shortness of breath, severe dizziness, passing out, change in balance, confusion, memory impairment, difficulty speaking, menstrual changes, or difficult urination
Discuss to the patient how taking alprazolam may cause drowsiness and sedation, so they should not drive, operate dangerous machinery, or perform any other activity or task that requires optimal attention.
Discuss how alcohol and/or illegal drugs with alprazolam increase the chances of life-threatening side effects.

Nurses can be invaluable in observing and verifying that the patient is adherent, not misusing the medication, and offering counsel. The pharmacist can verify dosing and check for drug interactions and inform the prescriber of signs of possible misuse (e.g., doctor shopping, early refills, etc.) When healthcare professionals function as an interprofessional team, alprazolam therapy stands to have increased odds of being effective while avoiding adverse events and misuse, leading to better patient outcomes. [Level V]

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Disclosure: Tobin George declares no relevant financial relationships with ineligible companies.

Disclosure: Jayson Tripp declares no relevant financial relationships with ineligible companies.

This book is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) ( http://creativecommons.org/licenses/by-nc-nd/4.0/ ), which permits others to distribute the work, provided that the article is not altered or used commercially. You are not required to obtain permission to distribute this article, provided that you credit the author and journal.

Cite this Page George TT, Tripp J. Alprazolam. [Updated 2023 Apr 24]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.

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Generic name: alprazolam systemic

Brand names: Xanax XR, Alprazolam Intensol, Xanax, Niravam

Boxed Warning

Risks from concomitant use with opioids

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Concentrate, Oral:

ALPRAZolam Intensol: 1 mg/mL (30 mL) [unflavored flavor]

Tablet, Oral:

Xanax: 0.25 mg [scored]

Xanax: 0.5 mg [scored; contains fd&c yellow #6 (sunset yellow)]

Xanax: 1 mg [scored; contains fd&c blue #2 (indigotine)]

Xanax: 2 mg [scored]

Generic: 0.25 mg, 0.5 mg, 1 mg, 2 mg

Tablet Disintegrating, Oral:

Tablet Extended Release 24 Hour, Oral:

ALPRAZolam XR: 0.5 mg

ALPRAZolam XR: 1 mg [contains fd&c yellow #10 (quinoline yellow)]

ALPRAZolam XR: 2 mg [contains fd&c blue #2 (indigotine)]

ALPRAZolam XR: 3 mg [contains fd&c blue #2 (indigotine), fd&c yellow #10 (quinoline yellow)]

Xanax XR: 0.5 mg

Xanax XR: 1 mg [contains fd&c yellow #10 (quinoline yellow)]

Xanax XR: 2 mg [contains fd&c blue #2 (indigotine)]

Xanax XR: 3 mg [contains fd&c blue #2 (indigotine), fd&c yellow #10 (quinoline yellow)]

Generic: 0.5 mg, 1 mg, 2 mg, 3 mg

Pharmacology

Mechanism of action.

Binds to stereospecific benzodiazepine receptors on the postsynaptic GABA neuron at several sites within the central nervous system, including the limbic system, reticular formation. Enhancement of the inhibitory effect of GABA on neuronal excitability results by increased neuronal membrane permeability to chloride ions. This shift in chloride ions results in hyperpolarization (a less excitable state) and stabilization. Benzodiazepine receptors and effects appear to be linked to the GABA-A receptors. Benzodiazepines do not bind to GABA-B receptors.

Pharmacokinetics/Pharmacodynamics

Readily absorbed; Extended release: Slower relative to immediate release formulation resulting in a concentration that is maintained 5 to 11 hours after dosing; rate increased following night time dosing (versus morning dosing)

Distribution

Immediate release: V d : 0.84 to 1.42 L/kg (Greenblatt 1993)

Hepatic via CYP3A4; forms two active metabolites (4-hydroxyalprazolam and α-hydroxyalprazolam [about half as active as alprazolam]) and an inactive metabolite benzophenone metabolite, however, the active metabolites are unlikely to contribute to much of the pharmacologic effects because of their low concentrations and lesser potencies.

Urine (as unchanged drug and metabolites)

Time to Peak

Immediate release: 1 to 2 hours

Extended release: Adolescents and Adults: ~9 hours, relatively steady from 4 to 12 hours (Glue 2006); decreased by 1 hour when administered at bedtime (as compared to morning administration); decreased by 33% when administered with a high-fat meal; increased by 33% when administered ≥1 hour after a high-fat meal

Orally-disintegrating tablet: 1.5 to 2 hours; occurs ~15 minutes earlier when administered with water; increased to ~4 hours when administered with a high-fat meal

Half-Life Elimination

Adults: Mean: 11.2 hours (Immediate release range: 6.3 to 26.9 hours; Extended release range: 10.7 to 15.8 hours); Orally-disintegrating tablet: Mean: 12.5 hours (range: 7.9 to 19.2 hours)

Alcoholic liver disease: 19.7 hours (range: 5.8 to 65.3 hours)

Obesity: 21.8 hours (range: 9.9 to 40.4 hours)

Elderly: 16.3 hours (range: 9 to 26.9 hours)

Protein Binding

80%; primarily to albumin

Use in Specific Populations

Special populations: race.

Maximal concentrations and half-life are approximately 15% and 25% higher in Asians.

Special Populations Note

Cigarette smoking: Concentrations may be reduced by up to 50% in smokers.

Use: Labeled Indications

Anxiety disorders (immediate release tablet, oral concentrate, orally-disintegrating tablets): Treatment of generalized anxiety disorder (GAD), short-term anxiety and anxiety association with depression

Panic disorder (extended-release tablets, oral solution, orally-disintegrating tablets, immediate-release tablets): Treatment of panic disorder, with or without agoraphobia

Contraindications

Hypersensitivity to alprazolam or any component of the formulation (cross-sensitivity with other benzodiazepines may exist); acute narrow-angle glaucoma; concurrent use with ketoconazole, itraconazole, or other potent CYP3A4 inhibitors.

Canadian labeling: Additional contraindications (not in US labeling): Myasthenia gravis; severe hepatic insufficiency; severe respiratory insufficiency; sleep apnea.

Dosage and Administration

Dosing: adult.

Note: Titrate dose gradually as needed and tolerated. Periodic reassessment and consideration of dosage reduction is recommended.

Anxiety disorders: Oral: Immediate release tablet, oral concentrate, orally-disintegrating tablet: Initial: 0.25 to 0.5 mg 3 times daily; titrate dose every 3 to 4 days; usual maximum: 4 mg/day. Patients requiring doses >4 mg/day should be increased cautiously.

Panic disorder: Oral:

Immediate release tablet, oral concentrate, orally-disintegrating tablet: Initial: 0.5 mg 3 times daily; titrate dose every 3 to 4 days in increments ≤1 mg/day. Mean effective dosage: 5 to 6 mg/day, in 3 or 4 divided doses; some patients may require as much as 10 mg/day.

Extended release: 0.5 to 1 mg once daily; titrate dose every 3 to 4 days in increments ≤1 mg/day (range: 3 to 6 mg/day).

Switching from immediate release to extended release: Patients may be switched to extended release tablets by taking the total daily dose of the immediate release tablets and giving it once daily using the extended release preparation.

Preoperative anxiety (off-label use): Oral: 0.5 mg 60-90 minutes before procedure (De Witte 2002)

Dose reduction: Abrupt discontinuation should be avoided. Daily dose may be decreased by 0.5 mg every 3 days; however, some patients may require a slower reduction. If withdrawal symptoms occur, resume previous dose and discontinue on a less rapid schedule.

Dosing: Geriatric

Note: Titrate gradually, if needed and tolerated. Periodic reassessment and consideration of dosage reduction is recommended.

Immediate release: Initial 0.25 mg 2 to 3 times/day

Extended release: Initial: 0.5 mg once daily

Dose reduction: Refer to adult dosing.

Dosing: Pediatric

Note: Titrate dose to effect; use lowest effective dose. The usefulness of this medication should be periodically reassessed.

Children ≥7 years and Adolescents <18 years: Limited data available: Oral: Immediate release: Initial: 0.005 to 0.02 mg/kg/dose 3 times daily (Kliegman 2007); dosing based on a trial in patients 7 to 16 years of age (n=13), initial doses of 0.005 mg/kg or 0.125 mg/dose were given 3 times/day for situational anxiety and increments of 0.125 to 0.25 mg/dose were used to increase doses to maximum of 0.02 mg/kg/dose or 0.06 mg/kg/ day ; a range of 0.375 to 3 mg/ day was needed (Pfefferbaum 1987). Another study in 17 children (8 to 17 years of age) with overanxious disorder or avoidant disorders used initial daily doses of 0.25 mg for children <40 kg and 0.5 mg for those >40 kg. The dose was titrated at 2-day intervals to a maximum of 0.04 mg/kg/ day . Required doses ranged from 0.5 to 3.5 mg/day with a mean of 1.6 mg/day. Based on clinical global ratings, alprazolam appeared to be better than placebo; however, this difference was not statistically significant (Simeon 1992).

Adolescents ≥18 years: Oral: Immediate release: Initial: 0.25 to 0.5 mg 3 times daily; titrate dose upward as needed every 3 to 4 days; usual maximum daily dose: 4 mg/ day . Patients requiring doses >4 mg/ day should be increased cautiously. Periodic reassessment and consideration of dosage reduction is recommended.

Panic disorder: Adolescents ≥18 years: Oral:

Immediate release: Initial: 0.5 mg 3 times daily; titrate dose upward as needed every 3 to 4 days in increments ≤1 mg/day; mean dose used in controlled trials: 5 to 6 mg/ day ; maximum daily dose: 10 mg/ day (rarely required)

Extended release: Initial: 0.5 to 1 mg once daily; titrate dose upward as needed every 3 to 4 days in increments ≤1 mg/day; usual dose: 3 to 6 mg/ day ; maximum daily dose: 10 mg/ day (rarely required)

Switching from immediate release to extended release: Administer the same total daily dose, but give once daily; if effect is not adequate, titrate dose as above.

Premenstrual dysphoric disorder: Limited data available: Adolescents: Oral: Initial dose: 0.25 mg 3 times daily; titrate as needed. Usual daily dose: 1.25 to 2.25 mg/ day (Kliegman 2011)

Discontinuation of therapy: Abrupt discontinuation should be avoided. Daily dose must be gradually decreased no more frequently than every 3 days; however, some patients may require a slower reduction. If withdrawal symptoms occur, resume previous dose and discontinue on a less rapid schedule.

Extemporaneously Prepared

Note: Commercial oral solution is available (Alprazolam Intensol™: 1 mg/mL [dye free, ethanol free, sugar free; contains propylene glycol])

A 1 mg/mL oral suspension may be made with tablets and one of three different vehicles (a 1:1 mixture of Ora-Sweet® and Ora-Plus®, a 1:1 mixture of Ora-Sweet® SF and Ora-Plus®, or a 1:4 mixture of cherry syrup with Simple Syrup, NF). Crush sixty 2 mg tablets in a mortar and reduce to a fine powder. Add 40 mL of vehicle and mix to a uniform paste; mix while adding the vehicle in incremental proportions to almost 120 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add a quantity of vehicle sufficient to make 120 mL. Label "shake well" and "refrigerate". Stable for 60 days.

Nahata MC, Pai VB, and Hipple TF, Pediatric Drug Formulations , 5th ed, Cincinnati, OH: Harvey Whitney Books Co, 2004.

Administration

Immediate release preparations: Can be administered sublingually if oral administration is not possible; absorption and onset of effect are comparable to oral administration (Scavone 1987; Scavone 1992)

Extended release tablet: Should be taken once daily in the morning; do not crush, break, or chew.

Oral concentrate: Use only the provided calibrated dropper to withdraw the prescribed dose. Mix the dose with ≥30 mL of juice or other liquid or semi-solid foods (eg, applesauce, pudding). The prepared mixture should be administered immediately.

Orally disintegrating tablets: Using dry hands, place tablet on top of tongue and allow to disintegrate. Administration with water is not necessary.

Dietary Considerations

Orally-disintegrating tablets may contain phenylalanine.

Immediate release tablets: Store at 20°C to 25°C (68°F to 77°F).

Extended release tablets: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Oral concentrate: Store at 20°C to 25°C (68°F to 77°F). Protect from moisture. Discard opened bottle after 90 days.

Orally disintegrating tablet: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from moisture.

ALPRAZolam Images

Drug Interactions

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Monitor therapy

Alizapride: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Aprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

ARIPiprazole: CYP3A4 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult full interaction monograph for specific recommendations. Monitor therapy

Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Avoid combination

Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Consider therapy modification

Bosentan: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Brexanolone: CNS Depressants may enhance the CNS depressant effect of Brexanolone. Monitor therapy

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Bromopride: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Avoid combination

Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants. Consider therapy modification

Cannabidiol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Cannabis: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Consider therapy modification

Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

CloZAPine: Benzodiazepines may enhance the adverse/toxic effect of CloZAPine. Management: Consider decreasing the dose of (or possibly discontinuing) benzodiazepines prior to initiating clozapine. Consider therapy modification

CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Monitor therapy

Conivaptan: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of ALPRAZolam. Management: Consider using an alternative agent that is less likely to interact. If combined, monitor for increased therapeutic/toxic effects of alprazolam if combined with a strong CYP3A4 inhibitor. Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Dofetilide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Dofetilide. Monitor therapy

Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. Monitor therapy

Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Consider therapy modification

Duvelisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Consider therapy modification

Erdafitinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Erdafitinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Erythromycin (Systemic): May increase the serum concentration of ALPRAZolam. Monitor therapy

Esketamine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Flibanserin: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Flibanserin. Monitor therapy

Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Consider therapy modification

FluvoxaMINE: May increase the serum concentration of ALPRAZolam. Monitor therapy

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fosnetupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

HYDROcodone: CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Avoid concomitant use of hydrocodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Indinavir: May increase the serum concentration of ALPRAZolam. Avoid combination

Itraconazole: May increase the serum concentration of ALPRAZolam. Avoid combination

Ivosidenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy

Ketoconazole (Systemic): May increase the serum concentration of ALPRAZolam. Avoid combination

Larotrectinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Lemborexant: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Lemborexant. Management: The maximum recommended dosage of lemborexant is 5 mg, no more than once per night, when coadministered with weak CYP3A4 inhibitors. Consider therapy modification

Lemborexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dosage adjustments of lemborexant and of concomitant CNS depressants may be necessary when administered together because of potentially additive CNS depressant effects. Close monitoring for CNS depressant effects is necessary. Consider therapy modification

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Monitor therapy

Lomitapide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Lomitapide. Management: Patients on lomitapide 5 mg/day may continue that dose. Patients taking lomitapide 10 mg/day or more should decrease the lomitapide dose by half. The lomitapide dose may then be titrated up to a max adult dose of 30 mg/day. Consider therapy modification

Lorlatinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Avoid concurrent use of lorlatinib with any CYP3A4 substrates for which a minimal decrease in serum concentrations of the CYP3A4 substrate could lead to therapeutic failure and serious clinical consequences. Consider therapy modification

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Melatonin: May enhance the sedative effect of Benzodiazepines. Monitor therapy

Methadone: Benzodiazepines may enhance the CNS depressant effect of Methadone. Management: Clinicians should generally avoid concurrent use of methadone and benzodiazepines when possible; any combined use should be undertaken with extra caution. Consider therapy modification

Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Consider therapy modification

MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Monitor therapy

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Consider therapy modification

Minocycline (Systemic): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Mitotane: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Consider therapy modification

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Netupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

NiMODipine: CYP3A4 Inhibitors (Weak) may increase the serum concentration of NiMODipine. Monitor therapy

OLANZapine: May enhance the adverse/toxic effect of Benzodiazepines. Management: Avoid concomitant use of parenteral benzodiazepines and IM olanzapine due to risks of additive adverse events (e.g., cardiorespiratory depression). Olanzapine prescribing information provides no specific recommendations regarding oral administration. Avoid combination

Ombitasvir, Paritaprevir, and Ritonavir: May increase the serum concentration of ALPRAZolam. Monitor therapy

Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir: May increase the serum concentration of ALPRAZolam. Monitor therapy

Opioid Agonists: CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Avoid combination

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Avoid combination

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Avoid combination

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Consider therapy modification

Pimozide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Pimozide. Avoid combination

Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Monitor therapy

Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Monitor therapy

ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Monitor therapy

Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Monitor therapy

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Simeprevir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Sodium Oxybate: Benzodiazepines may enhance the CNS depressant effect of Sodium Oxybate. Avoid combination

Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Consider therapy modification

Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Avoid concomitant use of tapentadol and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Teduglutide: May increase the serum concentration of Benzodiazepines. Monitor therapy

Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Tetrahydrocannabinol and Cannabidiol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Avoid combination

Theophylline Derivatives: May diminish the therapeutic effect of Benzodiazepines. Consider therapy modification

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Triazolam: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Triazolam. Management: Consider triazolam dose reduction in patients receiving concomitant weak CYP3A4 inhibitors. Consider therapy modification

Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Ubrogepant: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Ubrogepant. Management: In patients taking weak CYP3A4 inhibitors, the initial and second dose (if needed) of ubrogepant should be limited to 50 mg. Consider therapy modification

Yohimbine: May diminish the therapeutic effect of Antianxiety Agents. Monitor therapy

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Consider therapy modification

Adverse Reactions

Central nervous system: Drowsiness (immediate-release: 41% to 77%; extended-release: 23%), fatigue (immediate-release: 49%; extended-release: 14%), sedation (extended-release: 45%), ataxia (immediate-release: 40%; extended-release: 7% to 9%), memory impairment (immediate-release: 33%; extended-release: 15%), irritability (immediate-release: 33%; extended-release: ≥1%), cognitive dysfunction (immediate-release: 29%), dysarthria (immediate-release: 23%; extended-release: 11%), dizziness (immediate-release: 2% to 21%; extended-release: ≥1%), depression (extended-release: 1% to 12%)

Dermatologic: Skin rash (immediate-release: 11%; extended-release: <1%)

Endocrine & metabolic: Weight gain (immediate-release: 27%; extended-release: 5%), weight loss (immediate-release: 23%), decreased libido (6% to 14%)

Gastrointestinal: Increased appetite (immediate-release: 33%; extended-release: 7%), decreased appetite (immediate-release: 28%), constipation (immediate-release: 26%; extended-release: 8%), xerostomia (immediate-release: 15%)

Genitourinary: Difficulty in micturition (immediate-release: 12%; extended-release: ≥1%)

Cardiovascular: Hypotension (immediate-release: 5%; extended-release: <1%), chest pain (extended-release: ≥1%), palpitations (extended-release: ≥1%)

Central nervous system: Confusion (immediate-release: 10%; extended-release: 2%), altered mental status (extended-release: 7%), disinhibition (immediate-release: 3%), disturbance in attention (extended-release: 3%), equilibrium disturbance (extended-release: 3%), akathisia (immediate-release: 2%), disorientation (extended-release: 2%), lethargy (extended-release: 2%), talkativeness (immediate-release: 2%), derealization (≥1% to 2%), agitation (extended-release: ≥1%), depersonalization (extended-release: ≥1%), headache (extended-release: ≥1%), insomnia (extended-release: ≥1%), malaise (extended-release: ≥1%), nervousness (extended-release: ≥1%), nightmares (extended-release: ≥1%), restlessness (≥1%), vertigo (extended-release: ≥1%), anxiety (extended-release: 1%), feeling hot (immediate-release: 1%; extended-release: <1%), hypersomnia (extended-release: 1%), hypoesthesia (extended-release: 1%), dystonia

Dermatologic: Allergic skin reaction (≤4%), dermatitis (immediate-release: ≤4%), diaphoresis (extended-release: ≥1%), pruritus (extended-release: 1%)

Endocrine & metabolic: Menstrual disease (immediate-release: 10%; extended-release: 2%), increased libido (immediate-release: 8%; extended-release: ≥1%), change in libido (immediate-release: 7%), hot flash (extended-release: 2%)

Gastrointestinal: Nausea (extended-release: 6%), sialorrhea (immediate-release: 4% to 6%; extended-release: ≥1%), anorexia (extended-release: 2%), abdominal pain (extended-release: ≥1%), diarrhea (extended-release: ≥1%), dyspepsia (extended-release: ≥1%), vomiting (extended-release: ≥1%)

Genitourinary: Sexual disorder (immediate-release: 7%; extended-release: 2%), dysmenorrhea (extended-release: 4%), urinary incontinence (immediate-release: 2%; extended-release: <1%)

Neuromuscular & skeletal: Arthralgia (extended-release: 2%), dyskinesia (extended-release: 2%), myalgia (extended-release: 2%), back pain (extended-release: ≥1%), muscle cramps (extended-release: ≥1%), muscle twitching (extended-release: ≥1%), tremor (extended-release: ≥1%), weakness (extended-release: ≥1%), limb pain (extended-release: 1%)

Ophthalmic: Blurred vision (extended-release: ≥1%)

Respiratory: Dyspnea (extended-release: 2%), hyperventilation (extended-release: ≥1%), nasal congestion (extended-release: ≥1%), allergic rhinitis (extended-release: 1%)

Frequency not defined:

Central nervous system: Drug dependence, drug withdrawal

<1%, postmarketing, and/or case reports: Abnormal dreams, aggressive behavior, amnesia, angioedema, apathy, chest tightness, choking sensation, clumsiness, cold and clammy skin, diplopia, dysgeusia, dysphagia, edema, emotional lability, epistaxis, euphoria, falling, fever, galactorrhea, gastrointestinal disease, gynecomastia, hallucination, hangover effect, hepatic failure, hepatitis, homicidal ideation, hyperprolactinemia, hypomania, hypotonia, impaired consciousness, impulse control disorder, increased energy, increased liver enzymes, increased serum bilirubin, increased thirst, intoxicated feeling, jaundice, jitteriness, mania, mydriasis, otalgia, outbursts of anger, paraplegia, peripheral edema, photophobia, psychomotor retardation, relaxation, rhinorrhea, rigors, seizure, sensation of cold, sinus tachycardia, skin photosensitivity, sleep apnea, sleep talking, Stevens-Johnson syndrome, stupor, suicidal ideation, syncope, tinnitus, urinary frequency, urticaria, voice disorder

Warnings/Precautions

Concerns related to adverse effects:

Anterograde amnesia: Benzodiazepines have been associated with anterograde amnesia (Nelson 1999).
CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
Paradoxical reactions: Paradoxical reactions, including hyperactive or aggressive behavior, have been reported with benzodiazepines; risk may be increased in adolescent/pediatric patients, geriatric patients, or patients with a history of alcohol use disorder or psychiatric/personality disorders (Mancuso 2004).
Sleep-related activities: Hazardous sleep-related activities such as sleep-driving, cooking and eating food, and making phone calls while asleep have been noted with benzodiazepines (Dolder 2008).

Disease-related concerns:

Depression: Use caution in patients with depression, particularly if suicidal risk may be present; episodes of mania or hypomania have occurred in depressed patients treated with alprazolam.
Drug abuse: Use with caution in patients with a history of drug abuse or acute alcoholism; potential for drug dependency exists. Tolerance, psychological and physical dependence may occur with prolonged use (generally >10 days).
Hepatic impairment: Use with caution in patients with hepatic impairment.
Renal impairment: Use with caution in patients with renal impairment or predisposition to urate nephropathy; has weak uricosuric properties.
Respiratory disease: Use with caution in patients with respiratory disease.

Concurrent drug therapy issues:

Concomitant use with CYP inhibitors: Use with caution in patients taking strong CYP3A4 inhibitors, moderate or strong CYP3A4 inducers and major CYP3A4 substrates (see Drug Interactions); consider alternative agents that avoid or lessen the potential for CYP-mediated interactions.
Concomitant use with opioids: [US Boxed warning]: Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

Debilitated patients: Use with caution in debilitated patients; use lower starting dose.
Elderly patients: Elderly patients may be at an increased risk of death with use; risk has been found highest within the first 4 months of use in elderly dementia patients (Jennum 2015; Saarelainen 2018).
Fall risk: Use with extreme caution in patients who are at risk of falls; benzodiazepines have been associated with falls and traumatic injury (Nelson 1999).
Obese patients: Use with caution in obese patients; may have prolonged action when discontinued.
Smokers: Cigarette smoking may decrease alprazolam concentrations up to 50%.

Other warnings/precautions:

Appropriate use: Does not have analgesic, antidepressant, or antipsychotic properties.
Breakthrough anxiety: At the end of dosing interval, breakthrough anxiety may occur.
Tolerance: Alprazolam has a short half-life for a benzodiazepine and the duration of action after a single dose is determined by redistribution rather than metabolism. Tolerance does not develop to the anxiolytic effects (Vinkers 2012). Chronic use of this agent may increase the perioperative benzodiazepine dose needed to achieve desired effect.
Withdrawal: Rebound or withdrawal symptoms, including seizures, may occur following abrupt discontinuation or large decreases in dose (more common in adult patients receiving >4 mg/day or prolonged treatment); the risk of seizures appears to be greatest 24 to 72 hours following discontinuation of therapy. Use caution when reducing dose or withdrawing therapy; decrease slowly (eg, ≤0.5 mg every 3 days in adults) and monitor for withdrawal symptoms. Flumazenil may cause withdrawal in patients receiving long-term benzodiazepine therapy.

Monitoring Parameters

Respiratory and cardiovascular status

Pregnancy Risk Factor

Pregnancy considerations.

Benzodiazepines have the potential to cause harm to the fetus. Alprazolam and its metabolites cross the human placenta. Teratogenic effects have been observed with some benzodiazepines; however, additional studies are needed. The incidence of premature birth and low birth weights may be increased following maternal use of benzodiazepines; hypoglycemia and respiratory problems in the neonate may occur following exposure late in pregnancy. Neonatal withdrawal symptoms may occur within days to weeks after birth and “floppy infant syndrome” (which also includes withdrawal symptoms) has been reported with some benzodiazepines (Bergman 1992; Iqbal 2002; Wikner 2007). When treating pregnant females with panic disorder, psychosocial interventions should be considered prior to pharmacotherapy (APA 2009). If a benzodiazepine is needed in pregnancy, agents other than alprazolam are preferred (Larsen 2015).

Patient Education

What is this drug used for?

It is used to treat anxiety.
It is used to treat panic attacks.

Frequently reported side effects of this drug

Increased hunger
Lack of appetite
Constipation
Sexual dysfunction
Decreased sex drive
Weight change

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

Depression like thoughts of suicide, anxiety, emotional instability, or confusion.
Severe fatigue
Shortness of breath
Severe dizziness
Passing out
Change in balance
Trouble with memory
Difficulty speaking
Menstrual changes
Difficult urination
Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Source: Wolters Kluwer Health. Last updated February 6, 2020.

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Labeling Archives

Label: XANAX- alprazolam tablet

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Drug Label Info

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View NDC Code(s) NEW!
NDC (National Drug Code) - Each drug product is assigned this unique number which can be found on the drug's outer packaging." href="#" id="anch_dj_103">NDC Code(s): 0009-0029-01, 0009-0029-02, 0009-0029-14, 0009-0029-46, view more 0009-0055-01, 0009-0055-03, 0009-0055-15, 0009-0055-46, 0009-0090-01, 0009-0090-04, 0009-0090-13, 0009-0094-01, 0009-0094-03
Packager: PHARMACIA & UPJOHN COMPANY LLC
Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: CIV
Marketing Status: New Drug Application

Drug Label Information

Updated January 18, 2023

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Medication Guide: HTML
Official Label (Printer Friendly)

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS

See full prescribing information for complete boxed warning., recent major changes.

Warnings and Precautions ( 5.8 ) 1/2023

INDICATIONS AND USAGE

XANAX is a benzodiazepine indicated for the:

DOSAGE AND ADMINISTRATION

Dosage forms and strengths.

Tablets: 0.25 mg, 0.5 mg, 1 mg, and 2 mg ( 3 )

CONTRAINDICATIONS

Warnings and precautions, adverse reactions.

The most common adverse reactions reported in clinical trials for generalized anxiety disorder and panic disorder (incidence >5% and at least twice that of placebo) include: impaired coordination, hypotension, dysarthria, and increased libido. ( 6.1 )

To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Use in specific populations.

Lactation: Breastfeeding not recommended. ( 8.2 )

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 1/2023

FULL PRESCRIBING INFORMATION: CONTENTS *

1 indications and usage, 2 dosage and administration, 2.1 dosage in generalized anxiety disorder, 2.2 dosage in panic disorder, 2.3 discontinuation or dosage reduction of xanax, 2.4 dosage recommendations in geriatric patients, 2.5 dosage recommendations in patients with hepatic impairment, 2.6 dosage modifications for drug interactions, 3 dosage forms and strengths, 4 contraindications, 5 warnings and precautions, 5.1 risks from concomitant use with opioids, 5.2 abuse, misuse, and addiction, 5.3 dependence and withdrawal reactions, 5.4 effects on driving and operating machinery, 5.5 interaction with drugs that inhibit metabolism via cytochrome p450 3a, 5.6 patients with depression, 5.8 neonatal sedation and withdrawal syndrome, 5.9 risk in patients with impaired respiratory function, 6 adverse reactions, 6.1 clinical trials experience, 6.2 postmarketing experience, 7 drug interactions, 7.1 drugs having clinically important interactions with xanax, 7.2 drug/laboratory test interactions, 8 use in specific populations, 8.1 pregnancy, 8.2 lactation, 8.4 pediatric use, 8.5 geriatric use, 8.6 hepatic impairment, 9 drug abuse and dependence, 9.1 controlled substance, 9.3 dependence, 10 overdosage, 11 description, 12 clinical pharmacology, 12.1 mechanism of action, 12.3 pharmacokinetics, 13 nonclinical toxicology, 13.1 carcinogenesis, mutagenesis, impairment of fertility, 13.2 animal toxicology and/or pharmacology, 14 clinical studies, 14.1 generalized anxiety disorder, 14.2 panic disorder, 16 how supplied/storage and handling, 17 patient counseling information.

XANAX is indicated for the:

The recommended starting oral dosage of XANAX for the acute treatment of patients with GAD is 0.25 mg to 0.5 mg administered three times daily. Depending upon the response, the dosage may be adjusted at intervals of every 3 to 4 days. The maximum recommended dosage is 4 mg daily (in divided doses).

Use the lowest possible effective dose and frequently assess the need for continued treatment [see Warnings and Precautions (5.2) ] .

The recommended starting oral dosage of XANAX for the treatment of PD is 0.5 mg three times daily. Depending on the response, the dosage may be increased at intervals of every 3 to 4 days in increments of no more than 1 mg per day.

Controlled trials of XANAX in the treatment of panic disorder included dosages in the range of 1 mg to 10 mg daily. The mean dosage was approximately 5 mg to 6 mg daily. Occasional patients required as much as 10 mg per day.

For patients receiving doses greater than 4 mg per day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated with doses of XANAX greater than 4 mg per day for 3 months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit.

The necessary duration of treatment for PD in patients responding to XANAX is unknown. After a period of extended freedom from panic attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena [see Dosage and Administration (2.3) ] .

To reduce the risk of withdrawal reactions, use a gradual taper to discontinue XANAX or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly [see Warnings and Precautions (5.3) , Drug Abuse and Dependence (9.3) ] .

Reduced the dosage by no more than 0.5 mg every 3 days. Some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.

In a controlled postmarketing discontinuation study of panic disorder patients which compared the recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome.

In geriatric patients, the recommended starting oral dosage of XANAX is 0.25 mg, given 2 or 3 times daily. This may be gradually increased if needed and tolerated. Geriatric patients may be especially sensitive to the effects of benzodiazepines. If adverse reactions occur at the recommended starting dosage, the dosage may be reduced [see Use in Specific Populations (8.5) , Clinical Pharmacology (12.3) ] .

In patients with hepatic impairment, the recommended starting oral dosage of XANAX is 0.25 mg, given 2 or 3 times daily. This may be gradually increased if needed and tolerated. If adverse reactions occur at the recommended starting dose, the dosage may be reduced [see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ] .

XANAX should be reduced to half of the recommended dosage when a patient is started on ritonavir and XANAX together, or when ritonavir administered to a patient treated with XANAX. Increase the XANAX dosage to the target dose after 10 to 14 days of dosing ritonavir and XANAX together. It is not necessary to reduce XANAX dose in patients who have been taking ritonavir for more than 10 to 14 days.

XANAX is contraindicated with concomitant use of all strong CYP3A inhibitors, except ritonavir [see Contraindications (4) , Warnings and Precautions (5.5) ] .

XANAX tablets are available as:

XANAX is contraindicated in patients:

Concomitant use of benzodiazepines, including XANAX, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate.

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe XANAX concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of XANAX than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking XANAX, prescribe a lower initial dose of the opioid and titrate based upon clinical response.

Advise both patients and caregivers about the risks of respiratory depression and sedation when XANAX is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined [see Drug Interactions (7.1) ] .

The use of benzodiazepines, including XANAX, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death [see Drug Abuse and Dependence (9.2) ] .

Before prescribing XANAX and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). Use of XANAX, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of XANAX along with monitoring for signs and symptoms of abuse, misuse, and addiction. Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate.

To reduce the risk of withdrawal reactions, use a gradual taper to discontinue XANAX or reduce the dosage (a patient-specific plan should be used to taper the dose) [see Dosage and Administration (2.3) ] .

Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use.

Acute Withdrawal Reactions

The continued use of benzodiazepines, including XANAX, may lead to clinically significant physical dependence. Abrupt discontinuation or rapid dosage reduction of XANAX after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) [see Drug Abuse and Dependence (9.3) ] .

Protracted Withdrawal Syndrome

In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months [see Drug Abuse and Dependence (9.3) ] .

Certain adverse clinical events, some life-threatening, are a direct consequence of physical dependence to XANAX. These include a spectrum of withdrawal symptoms; the most important is seizure [see Drug Abuse and Dependence (9.3)] . Even after relatively short-term use at doses of ≤4 mg/day, there is some risk of dependence. Spontaneous reporting system data suggest that the risk of dependence and its severity appear to be greater in patients treated with doses greater than 4 mg/day and for long periods (more than 12 weeks). However, in a controlled postmarketing discontinuation study of panic disorder patients who received XANAX, the duration of treatment (3 months compared to 6 months) had no effect on the ability of patients to taper to zero dose. In contrast, patients treated with doses of XANAX greater than 4 mg/day had more difficulty tapering to zero dose than those treated with less than 4 mg/day.

In a controlled clinical trial in which 63 patients were randomized to XANAX and where withdrawal symptoms were specifically sought, the following were identified as symptoms of withdrawal: heightened sensory perception, impaired concentration, dysosmia, clouded sensorium, paresthesias, muscle cramps, muscle twitch, diarrhea, blurred vision, appetite decrease, and weight loss. Other symptoms, such as anxiety and insomnia, were frequently seen during discontinuation, but it could not be determined if they were due to return of illness, rebound, or withdrawal.

Interdose Symptoms

Early morning anxiety and emergence of anxiety symptoms between doses of XANAX have been reported in patients with panic disorder taking prescribed maintenance doses. These symptoms may reflect the development of tolerance or a time interval between doses which is longer than the duration of clinical action of the administered dose. In either case, it is presumed that the prescribed dose is not sufficient to maintain plasma levels above those needed to prevent relapse, rebound, or withdrawal symptoms over the entire course of the interdosing interval.

Because of its CNS depressant effects, patients receiving XANAX should be cautioned against engaging in hazardous occupations or activities requiring complete mental alertness such as operating machinery or driving a motor vehicle. For the same reason, patients should be cautioned about the concomitant use of alcohol and other CNS depressant drugs during treatment with XANAX [see Drug Interactions (7.1) ] .

The initial step in alprazolam metabolism is hydroxylation catalyzed by cytochrome P450 3A (CYP3A). Drugs that inhibit this metabolic pathway may have a profound effect on the clearance of alprazolam.

Strong CYP3A Inhibitors

XANAX is contraindicated in patients receiving strong inhibitors of CYP3A (such as azole antifungal agents), except ritonavir [see Contraindications (4) ] . Ketoconazole and itraconazole have been shown in vivo to increase plasma alprazolam concentrations 3.98 fold and 2.70 fold, respectively.

Dosage adjustment is necessary when XANAX and ritonavir are initiated concomitantly or when ritonavir is added to a stable dosage of XANAX [see Dosage and Administration (2.6) , Drug Interactions (7.1) ] .

Drugs demonstrated to be CYP3A inhibitors on the basis of clinical studies involving alprazolam: nefazodone, fluvoxamine, and cimetidine [see Drug Interaction (7.1) , Clinical Pharmacology (12.3) ] . Use caution and consider dose reduction of XANAX, as appropriate, during co-administration with these drugs.

Benzodiazepines may worsen depression. Panic disorder has been associated with primary and secondary major depressive disorders and increased reports of suicide among untreated patients. Consequently, appropriate precautions (e.g., limiting the total prescription size and increased monitoring for suicidal ideation) should be considered in patients with depression.

Episodes of hypomania and mania have been reported in association with the use of XANAX in patients with depression [see Adverse Reactions (6.2) ] .

Use of XANAX late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate [see Use in Specific Populations (8.1) ] . Monitor neonates exposed to XANAX during pregnancy or labor for signs of sedation and monitor neonates exposed to XANAX during pregnancy for signs of withdrawal; manage these neonates accordingly.

There have been reports of death in patients with severe pulmonary disease shortly after the initiation of treatment with XANAX. Closely monitor patients with impaired respiratory function. If signs and symptoms of respiratory depression, hypoventilation, or apnea occur, discontinue XANAX.

The following clinically significant adverse reactions are described elsewhere in the labeling:

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data in the two tables below are estimates of adverse reaction incidence among adult patients who participated in:

In addition to the adverse reactions (i.e., greater than 1%) enumerated in the table above for patients with generalized anxiety disorder, the following adverse reactions have been reported in association with the use of benzodiazepines: dystonia, irritability, concentration difficulties, anorexia, transient amnesia or memory impairment, loss of coordination, fatigue, seizures, sedation, slurred speech, jaundice, musculoskeletal weakness, pruritus, diplopia, dysarthria, changes in libido, menstrual irregularities, incontinence and urinary retention.

In addition to the reactions (i.e., greater than 1%) enumerated in the table above for patients with panic disorder, the following adverse reactions have been reported in association with the use of XANAX: seizures, hallucinations, depersonalization, taste alterations, diplopia, elevated bilirubin, elevated hepatic enzymes, and jaundice.

Adverse Reactions Reported as Reasons for Discontinuation in Treatment of Panic Disorder in Placebo-Controlled Trials

In a larger database comprised of both controlled and uncontrolled studies in which 641 patients received XANAX, discontinuation-emergent symptoms which occurred at a rate of over 5% in patients treated with XANAX and at a greater rate than the placebo-treated group are shown in Table 3.

There have also been reports of withdrawal seizures upon rapid decrease or abrupt discontinuation of XANAX [see Warning and Precautions (5.2) and Drug Abuse and Dependence (9.3) ] .

Paradoxical reactions such as stimulation, increased muscle spasticity, sleep disturbances, hallucinations, and other adverse behavioral effects such as agitation, rage, irritability, and aggressive or hostile behavior have been reported rarely. In many of the spontaneous case reports of adverse behavioral effects, patients were receiving other CNS drugs concomitantly and/or were described as having underlying psychiatric conditions. Should any of the above events occur, alprazolam should be discontinued. Isolated published reports involving small numbers of patients have suggested that patients who have borderline personality disorder, a prior history of violent or aggressive behavior, or alcohol or substance abuse may be at risk for such events. Instances of irritability, hostility, and intrusive thoughts have been reported during discontinuation of alprazolam in patients with posttraumatic stress disorder.

The following adverse reactions have been identified during postapproval use of XANAX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Endocrine disorders: Hyperprolactinemia

General disorders and administration site conditions: Edema peripheral

Hepatobiliary disorders: Hepatitis, hepatic failure

Investigations: Liver enzyme elevations

Psychiatric disorders: Hypomania, mania

Reproductive system and breast disorders: Gynecomastia, galactorrhea

Skin and subcutaneous tissue disorders: Photosensitivity reaction, angioedema, Stevens-Johnson syndrome

Table 4 includes clinically significant drug interactions with XANAX [see Clinical Pharmacology (12.3) ] .

Although interactions between benzodiazepines and commonly employed clinical laboratory tests have occasionally been reported, there is no consistent pattern for a specific drug or specific test.

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including XANAX, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/.

Risk Summary

Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see Warnings and Precautions (5.8) and Clinical Considerations) ] . Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects ( see Data ).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations

Fetal/neonatal adverse reactions.

Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia, and sedation in neonates. Monitor neonates exposed to XANAX during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems. Monitor neonates exposed to XANAX during pregnancy for signs of withdrawal. Manage these neonates accordingly [see Warnings and Precautions (5.8) ] .

Published data from observational studies on the use of benzodiazepines during pregnancy do not report a clear association with benzodiazepines and major birth defects. Although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted. In addition, the majority of recent case-control and cohort studies of benzodiazepine use during pregnancy, which were adjusted for confounding exposures to alcohol, tobacco, and other medications, have not confirmed these findings.

Limited data from published literature reports the presence of alprazolam in human breast milk. There are reports of sedation, poor feeding and poor weight gain in infants exposed to benzodiazepines through breast milk. The effects of alprazolam on lactation are unknown.

Because of the potential for serious adverse reactions, including sedation and withdrawal symptoms in breastfed infants, advise patients that breastfeeding is not recommended during treatment with XANAX.

Safety and effectiveness of XANAX have not been established in pediatric patients.

XANAX-treated geriatric patients had higher plasma concentrations of alprazolam (due to reduced clearance) compared to younger adult patients receiving the same doses. Therefore, dosage reduction of XANAX is recommended in geriatric patients [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3) ] .

Patients with alcoholic liver disease exhibit a longer elimination half-life (19.7 hours), compared to healthy subjects (11.4 hours). This may be caused by decreased clearance of alprazolam in patients with alcoholic liver disease. Dosage reduction of XANAX is recommended in patients with hepatic impairment [see Dosage and Administration (2.4) , Clinical Pharmacology (12.3) ] .

XANAX contains alprazolam, which is a Schedule IV controlled substance.

XANAX is a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. Abuse and misuse of benzodiazepines may lead to addiction.

Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. Benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders [see Warnings and Precautions (5.2) ] .

The following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo.

The following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. Death is more often associated with polysubstance use (especially benzodiazepines with other CNS depressants such as opioids and alcohol).

XANAX may produce physical dependence from continued therapy. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use [see Warnings and Precautions (5.3) ] .

To reduce the risk of withdrawal reactions, use a gradual taper to discontinue XANAX or reduce the dosage [see Dosage and Administration (2.3) , Warnings and Precautions (5.3) ] .

Acute Withdrawal Signs and Symptoms

Acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. More severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidality.

Protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. Protracted withdrawal symptoms may last weeks to more than 12 months. As a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used.

Tolerance to XANAX may develop from continued therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Tolerance to the therapeutic effect of XANAX may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur. In severe overdosage cases, patients may develop respiratory depression and coma. Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal [see Warnings and Precautions (5.2) ] . Markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage.

In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway management. Flumazenil, a specific benzodiazepine receptor antagonist indicated for the complete or partial reversal of the sedative effects of benzodiazepines in the management of benzodiazepine overdosage, can lead to withdrawal and adverse reactions, including seizures, particularly in the context of mixed overdosage with drugs that increase seizure risk (e.g., tricyclic and tetracyclic antidepressants) and in patients with long-term benzodiazepine use and physical dependency. The risk of withdrawal seizures with flumazenil use may be increased in patients with epilepsy. Flumazenil is contraindicated in patients who have received a benzodiazepine for control of a potentially life-threatening condition (e.g., status epilepticus). If the decision is made to use flumazenil, it should be used as an adjunct to, not as a substitute for, supportive management of benzodiazepine overdosage. See the flumazenil injection Prescribing Information.

Consider contacting the Poison Help Line (1-800-222-1222), or a medical toxicologist for additional overdosage management recommendations.

XANAX contains alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds.

The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine.

The structural formula is:

Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH.

Each XANAX tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam.

Inactive ingredients: cellulose, corn starch, docusate sodium, lactose, magnesium stearate, silicon dioxide and sodium benzoate. In addition, the 0.5 mg tablet contains FD&C Yellow No. 6 and the 1 mg tablet contains FD&C Blue No. 2.

Alprazolam is a 1,4 benzodiazepine. Alprazolam exerts its effect for the acute treatment of generalized anxiety disorder and panic disorder through binding to the benzodiazepine site of gamma‑aminobutyric acid-A (GABA A ) receptors in the brain and enhances GABA-mediated synaptic inhibition.

Plasma levels of alprazolam increase proportionally to the dose over the range of 0.5 to 3.0 mg.

Following oral administration, peak plasma concentration of alprazolam (C max ) occurs in 1 to 2 hours post dose.

Distribution

Alprazolam is 80% bound to human serum protein, and albumin accounts for the majority of the binding.

Elimination

The mean plasma elimination half-life (T 1/2 ) of alprazolam is approximately 11.2 hours (range: 6.3 to 26.9 hours) in healthy adults.

Alprazolam is extensively metabolized in humans, primarily by cytochrome P450 3A4 (CYP3A4), to 2 major active metabolites in the plasma: 4-hydroxyalprazolam and α-hydroxyalprazolam. The plasma circulation levels of the two active metabolites are less than 4% of the parent. The reported relative potencies in benzodiazepine receptor binding experiments and in animal models of induced seizure inhibition are 0.20 and 0.66, respectively, for 4-hydroxyalprazolam and α-hydroxyalprazolam. The low concentrations and low potencies of 4-hydroxyalprazolam and α-hydroxyalprazolam indicate that they unlikely contribute much to the effects of alprazolam. A benzophenone derived from alprazolam is also found in humans. Their half-lives appear to be similar to that of alprazolam.

Alprazolam and its metabolites are excreted primarily in the urine.

Specific Populations

Geriatric patients.

The mean T 1/2 of alprazolam was 16.3 hours (range: 9.0 to 26.9 hours) in healthy elderly subjects compared to 11.0 hours (range: 6.3 to -15.8 hours, n=16) in healthy younger adult subjects.

Obese Patients

The mean T 1/2 of alprazolam was 21.8 hours (range: 9.9 to 40.4 hours) in a group of obese subjects.

Patients with Hepatic Impairment

The mean T 1/2 of alprazolam was 19.7 hours (range: 5.8 to 65.3 hours) in patients with alcoholic liver disease.

Racial or Ethnic Groups

Maximal concentrations and T 1/2 of alprazolam are approximately 15% and 25% higher in Asians compared to Caucasians.

Alprazolam concentrations may be reduced by up to 50% in smokers compared to non-smokers.

Drug Interaction Studies

In vivo studies.

Most of the interactions that have been documented with alprazolam are with drugs that modulate CYP3A4 activity.

Compounds that are inhibitors or inducers of CYP3A would be expected to increase or decrease plasma alprazolam concentrations, respectively. Drug products that have been studied in vivo, along with their effect on increasing alprazolam AUC, are as follows: ketoconazole, 3.98 fold; itraconazole, 2.66 fold; nefazodone, 1.98 fold; fluvoxamine, 1.96 fold; and erythromycin, 1.61 fold [see Contraindications (4) , Warnings and Precautions (5.5) , Drug Interactions (7.2) ] . Other studied drugs include:

Cimetidine: Coadministration of cimetidine increased the maximum plasma concentration of alprazolam by 82%, decreased clearance by 42%, and increased T 1/2 by 16%.

Fluoxetine: Coadministration of fluoxetine with alprazolam increased the maximum plasma concentration of alprazolam by 46%, decreased clearance by 21%, increased T 1/2 by 17%, and decreased measured psychomotor performance.

Oral Contraceptives: Coadministration of oral contraceptives increased the maximum plasma concentration of alprazolam by 18%, decreased clearance by 22%, and increased T 1/2 by 29%.

Carbamazepine: The oral clearance of alprazolam (given in a 0.8 mg single dose) was increased from 0.90±0.21 mL/min/kg to 2.13±0.54 mL/min/kg and the elimination T 1/2 was shortened (from 17.1±4.9 to 7.7±1.7 hour) following administration of 300 mg per day carbamazepine for 10 days [see Drug Interactions (7.2) ] . However, the carbamazepine dose used in this study was fairly low compared to the recommended doses (1000-1200 mg per day); the effect at usual carbamazepine doses is unknown.

Ritonavir: Interactions involving HIV protease inhibitors (e.g., ritonavir) and alprazolam are complex and time dependent. Short-term low doses of ritonavir (4 doses of 200 mg) increased mean AUC of alprazolam by about 2.5-fold, and did not significantly affect C max of alprazolam. The elimination T 1/2 was prolonged (30 hours versus 13 hours). However, upon extended exposure to ritonavir (500 mg, twice daily for 10 days), CYP3A induction offset this inhibition. Alprazolam AUC and C max was reduced by 12% and 16%, respectively, in the presence of ritonavir. The elimination T 1/2 of alprazolam was not significantly changed [see Warnings and Precautions (5.5) ] .

Sertraline: A single dose of alprazolam 1 mg and steady state dose of sertraline (50 mg to 150 mg per day) did not reveal any clinically significant changes in the pharmacokinetics of alprazolam.

Imipramine and Desipramine: The steady state plasma concentrations of imipramine and desipramine have been reported to be increased an average of 31% and 20%, respectively, by the concomitant administration of XANAX in doses up to 4 mg per day.

Warfarin: Alprazolam did not affect the prothrombin or plasma warfarin levels in male volunteers administered sodium warfarin orally.

In Vitro Studies

Data from in vitro studies of alprazolam suggest a possible drug interaction of alprazolam with paroxetine. The ability of alprazolam to induce human hepatic enzyme systems has not yet been determined.

Carcinogenesis

No evidence of carcinogenic potential was observed in rats or mice administered alprazolam for 2 years at doses up to 30 and 10 mg/kg day respectively. These doses are 29 times and 4.8 times the maximum recommended human dose of 10 mg/day based on mg/m 2 body surface area, respectively.

Mutagenesis

Alprazolam was negative in the in vitro Ames bacterial reverse mutation assay and DNA Damage/Alkaline Elution Assay and in vivo rat micronucleus genetic toxicology assays.

Impairment of Fertility

Alprazolam produced no impairment of fertility in rats at doses up to 5 mg/kg per day, which is approximately 5 times the maximum recommended human dose of 10 mg per day based on mg/m 2 body surface area.

When rats were treated with alprazolam at oral doses of 3 mg, 10 mg, and 30 mg/kg day (3 to 29 times the maximum recommended human dose based on mg/m 2 body surface area) for 2 years, a tendency for a dose related increase in the number of cataracts was observed in females and a tendency for a dose related increase in corneal vascularization was observed in males. These lesions did not appear until after 11 months of treatment.

XANAX was compared to placebo in double-blind clinical studies (doses up to 4 mg per day) in patients with a diagnosis of anxiety or anxiety with associated depressive symptomatology. XANAX was significantly better than placebo at each of the evaluation periods of these 4-week studies as judged by the following psychometric instruments: Physician’s Global Impressions, Hamilton Anxiety Rating Scale, Target Symptoms, Patient’s Global Impressions, and Self-Rating Symptom Scale.

The effectiveness of XANAX in the treatment of panic disorder was studied in 3 short-term, placebo-controlled studies (up to 10 weeks) in patients with diagnoses closely corresponding to DSM-III-R criteria for panic disorder.

The average dose of XANAX was 5 mg to 6 mg per day in 2 of the studies, and the doses of XANAX were fixed at 2 mg and 6 mg per day in the third study. In all 3 studies, XANAX was superior to placebo on a variable defined as “the number of patients with zero panic attacks” (range, 37% to 83% met this criterion), as well as on a global improvement score. In 2 of the 3 studies, XANAX was superior to placebo on a variable defined as “change from baseline on the number of panic attacks per week” (range, 3.3 to 5.2), and also on a phobia rating scale. A subgroup of patients who improved on XANAX during short-term treatment in 1 of these trials was continued on an open basis up to 8 months, without apparent loss of benefit.

XANAX is supplied in the following strengths and package configurations:

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Advise the patient to read the FDA-approved patient labeling ( Medication Guide ).

Risks from Concomitant Use with Opioids

Advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when XANAX is used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined [see Warnings and Precautions (5.1) , Drug Interactions (7.1) ] .

Abuse, Misuse, and Addiction

Inform patients that the use of XANAX, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances. Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug [see Warnings and Precautions (5.2) , Drug Abuse and Dependence (9.2) ] .

Withdrawal Reactions

Inform patients that the continued use of XANAX may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of XANAX may precipitate acute withdrawal reactions, which can be life-threatening. Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months. Instruct patients that discontinuation or dosage reduction of XANAX may require a slow taper [see Warnings and Precautions (5.3) , Drug Abuse and Dependence (9.3) ] .

Effects on Driving and Operating Machinery

Advise patients not to drive a motor vehicle or operate heavy machinery while taking XANAX due to its CNS depressant effects. Also advise patients to avoid use of alcohol or other CNS depressants while taking XANAX [see Warnings and Precautions (5.3) ] .

Patients with Depression

Advise patients, their families, and caregivers to look for signs of suicidality or worsening depression, and to inform the patient’s healthcare provider immediately [see Warnings and Precautions (5.6) ] .

Concomitant Medications

Advise patients to inform their healthcare provider of all medicines they take, including prescription and nonprescription medications, vitamins and herbal supplements [see Drug Interactions (7) ] .

Advise pregnant females that use of XANAX late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in newborns [see Warnings and Precautions (5.8) , Use in Specific Populations (8.1) ] . Instruct patients to inform their healthcare provider if they are pregnant.

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to XANAX during pregnancy [see Use in Specific Populations (8.1) ] .

Advise patients that breastfeeding is not recommended during treatment with XANAX [see Use in Specific Populations (8.2) ] .

Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A.

UPJ:XNXT:RX2

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 1/2023

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 0009-0029-01

alprazolam tablets, USP

100 Tablets Rx only

Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP].

Protect from light.

Dispense in tight (USP), light-resistant, child-resistant containers.

DOSAGE AND USE: See accompanying prescribing information.

Each tablet contains 0.25 mg alprazolam.

Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, NY, NY 10017

NDC 0009-0055-01

Each tablet contains 0.5 mg alprazolam.

NDC 0009-0090-01

Each tablet contains 1 mg alprazolam.

NDC 0009-0094-01

Each tablet contains 2 mg alprazolam.

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Why is this medication prescribed?

How should this medicine be used, other uses for this medicine, what special precautions should i follow, what special dietary instructions should i follow, what should i do if i forget a dose, what side effects can this medication cause, what should i know about storage and disposal of this medication, in case of emergency/overdose, what other information should i know, brand names, important warning:.

Alprazolam may increase the risk of serious or life-threatening breathing problems, sedation, or coma if used along with certain medications. Tell your doctor if you are taking or plan to take certain opiate medications for cough such as codeine (in Triacin-C, in Tuzistra XR) or hydrocodone (in Anexsia, in Norco, in Zyfrel) or for pain such as codeine (in Fiorinal), fentanyl (Actiq, Duragesic, Subsys, others), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Astramorph, Duramorph PF, Kadian), oxycodone (in Oxycet, in Percocet, in Roxicet, others), and tramadol (Conzip, Ultram, in Ultracet). Your doctor may need to change the dosages of your medications and will monitor you carefully. If you take alprazolam with any of these medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care immediately: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.

Alprazolam may be habit forming. Do not take a larger dose, take it more often, or for a longer time than your doctor tells you to. Tell your doctor if you have ever drunk large amounts of alcohol, if you use or have ever used street drugs, or have overused prescription medications. Do not drink alcohol or use street drugs during your treatment. Drinking alcohol or using street drugs during your treatment with alprazolam also increases the risk that you will experience these serious, life-threatening side effects. Also tell your doctor if you have or have ever had depression or another mental illness.

Alprazolam may cause a physical dependence (a condition in which unpleasant physical symptoms occur if a medication is suddenly stopped or taken in smaller doses), especially if you take it for several days to several weeks. Do not stop taking this medication or take fewer doses without talking to your doctor. Stopping alprazolam suddenly can worsen your condition and cause withdrawal symptoms that may last for several weeks to more than 12 months. Your doctor probably will decrease your alprazolam dose gradually. Call your doctor or get emergency medical treatment if you experience any of the following symptoms: unusual movements; ringing in your ears; anxiety; memory problems; difficulty concentrating; sleep problems; seizures; shaking; muscle twitching; changes in mental health; depression; burning or prickling feeling in hands, arms, legs or feet; seeing or hearing things that others do not see or hear; thoughts of harming or killing yourself or others; overexcitement; or losing touch with reality.

Alprazolam is used to treat anxiety disorders and panic disorder (sudden, unexpected attacks of extreme fear and worry about these attacks). Alprazolam is in a class of medications called benzodiazepines. It works by decreasing abnormal excitement in the brain.

Alprazolam comes as a tablet, an extended-release tablet, an orally disintegrating tablet (tablet that dissolves quickly in the mouth), and a concentrated solution (liquid) to take by mouth. The tablet, orally disintegrating tablet, and concentrated solution usually are taken two to four times a day. The extended-release tablet is taken once daily, usually in the morning. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take alprazolam exactly as directed.

To take the concentrated liquid, use only the dropper that came with your prescription. Draw into the dropper the amount prescribed for one dose. Squeeze the dropper contents into a liquid or semisolid food such as water, juice, soda, applesauce, or pudding. Stir the liquid or food gently for a few seconds. The concentrated liquid will blend completely with the food. Drink or eat the entire mixture immediately. Do not store for future use.

Remove the orally disintegrating tablet from the bottle just before it is time for your dose. With dry hands, open the bottle, remove the tablet, and immediately place it on your tongue. The tablet will dissolve and can be swallowed with saliva. The orally disintegrating tablet can be taken with or without water.

Swallow the extended-release tablets whole; do not chew, crush, or break them.

Your doctor will probably start you on a low dose of alprazolam and gradually increase your dose, not more than once every 3 or 4 days.

Alprazolam is also sometimes used to treat depression, fear of open spaces (agoraphobia), and premenstrual syndrome. Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking alprazolam,

tell your doctor and pharmacist if you are allergic to alprazolam, chlordiazepoxide (Librium, in Librax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), oxazepam, quazepam (Doral), temazepam (Restoril), triazolam (Halcion), any other medications, or any of the ingredients in alprazolam products. Ask your pharmacist for a list of the ingredients.
tell your doctor if you are taking itraconazole (Onmel, Sporanox) or ketoconazole (Nizoral). Your doctor will probably tell you not to take alprazolam.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements, you are taking. Be sure to mention any of the following: amiodarone (Cordarone, Nexterone, Pacerone); antidepressants ('mood elevators') such as desipramine (Norpramin), imipramine (Tofranil), and nefazodone; antifungals such as fluconazole (Diflucan), posaconazole (Noxafil), or voriconazole (Vfend); antihistamines; cimetidine (Tagamet); clarithromycin (Biaxin, in Prevpac); cyclosporine (Gengraf, Neoral, Sandimmune); diltiazem (Cardizem, Cartia XT, Tiazac); ergotamine (Ergomar, in Cafergot, in Migergot); erythromycin (E.E.S., ERYC, others); isoniazid (Laniazid, in Rifamate, in Rifater); medications for mental illness and seizures; nicardipine (Cardene); nifedipine (Adalat, Afeditab CR, Procardia); oral contraceptives (birth control pills); selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor and pharmacist what herbal products you are taking, especially St. John's wort.
tell your doctor if you have glaucoma (increased pressure in the eye that may cause loss of sight). Your doctor may tell you not to take alprazolam.
tell your doctor if you have or have ever had seizures or lung, kidney, or liver disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Alprazolam may harm the fetus. If you become pregnant while taking alprazolam, call your doctor.
talk to your doctor about the risks and benefits of taking this medication if you are 65 years of age or older. Older adults should receive low doses of alprazolam because higher doses may not work better and may cause serious side effects.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking alprazolam.
you should know that alprazolam may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

Talk to your doctor about drinking grapefruit juice while taking this medicine.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Alprazolam may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

light-headedness
irritability
talkativeness
difficulty concentrating
increased salivation
changes in sex drive or ability
constipation
changes in appetite
weight changes
difficulty urinating

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

shortness of breath
severe skin rash
yellowing of the skin or eyes
problems with speech
problems with coordination or balance

Alprazolam may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( http://www.fda.gov/Safety/MedWatch ) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Discard any cotton in the bottle containing orally disintegrating tablets and close the bottle tightly.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( http://goo.gl/c4Rm4p ) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

problems with coordination
loss of consciousness

Keep all appointments with your doctor.

Do not let anyone else take your medication. Alprazolam is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Niravam ® ¶

¶ This branded product is no longer on the market. Generic alternatives may be available.

Xanax Dosage

Generic name: ALPRAZOLAM 0.25mg Dosage form: tablet Drug class: Benzodiazepines

Medically reviewed by Drugs.com. Last updated on Jan 18, 2023.

Dosage in Generalized Anxiety Disorder

Use the lowest possible effective dose and frequently assess the need for continued treatment [see Warnings and Precautions (5.2) ] .

Dosage in Panic Disorder

Discontinuation or Dosage Reduction of XANAX

Reduced the dosage by no more than 0.5 mg every 3 days. Some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.

Dosage Recommendations in Geriatric Patients

Dosage Recommendations in Patients with Hepatic Impairment

Dosage Modifications for Drug Interactions

XANAX is contraindicated with concomitant use of all strong CYP3A inhibitors, except ritonavir [see Contraindications (4) , Warnings and Precautions (5.5) ] .

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Alprazolam, sold under the brand name Xanax among others, is a fast-acting, potent tranquilizer of moderate duration within the triazolobenzodiazepine group of chemicals called benzodiazepines. Alprazolam is most commonly used in management of anxiety disorders, specifically panic disorder or generalized anxiety disorder (GAD). Other uses include the treatment of chemotherapy-induced nausea ...
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