Alprazolam

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Dosage should be individualized for maximum beneficial effect.
• While the usual daily dosages given below will meet the needs of most patients, there will be some who require doses greater than 4 mg per day.
• In such cases, the dosage should be increased cautiously to avoid adverse reactions.
• In general, benzodiazepines should be prescribed for short periods.
• Reevaluate the need for continued therapy before extending the treatment period.
• Indication Recommended Dose Anxiety Disorder ( 2.1 ) Initial:
• 0.25 mg to 0.5 mg given three times daily.
• Maximum: 4 mg per day given in divided doses.
• Panic Disorder ( 2.2 ) Initial: 0.5 mg given three times daily.
• Maximum: Doses up to 10 mg per day may be required to achieve a successful response.
• With dry hands, place the tablet on top of the tongue where it will disintegrate and be swallowed with saliva ( 2.5 ).
• Depending on response, the dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days ( 2.1 , 2.2 ).
• Use the lowest possible effective dose.
• Periodically reassess the need for continued treatment ( 2.1 ).
• In general, benzodiazepines should be prescribed for short periods ( 2 ).
• Discontinuation of treatment or dose reduction should be gradual and under close physician supervision.
• Decrease the dosage by no more than 0.5 mg per day every 3 days.
• Some patients may require an even slower dosage reduction ( 2.1 , 2.2 ).
• Dosing in elderly: the starting dose is 0.25 mg, given two or three times daily ( 2.4 ).
• Severe hepatic impairment:
• the starting dose is 0.25 mg, given two or three times daily ( 2.4 ).
• 2.1 Generalized Anxiety Disorder Initiate treatment with a dose of 0.25 mg to 0.5 mg three times daily.
• The dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses.
• Use the lowest possible effective dose, and periodically reassess the need for continued treatment.
• The risk of dependence can increase with dose and duration of treatment.
• 2.2 Panic Disorder The successful treatment of many panic disorder patients has required the use of alprazolam at doses greater than 4 mg daily.
• In controlled trials conducted to establish the efficacy of alprazolam in panic disorder, doses in the range of 1 mg to 10 mg daily were used.
• The mean dosage employed was approximately 5 mg to 6 mg daily.
• Among the approximately 1700 patients participating in the panic disorder development program, about 300 received alprazolam in dosages of greater than 7 mg per day, including approximately 100 patients who received maximum dosages of greater than 9 mg per day.
• Occasional patients required as much as 10 mg a day to achieve a successful response.
• Dose Titration Initiate treatment with a dose of 0.5 mg three times daily.
• Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg per day.
• Slower titration to the dose levels greater than 4 mg per day may be advisable to allow full expression of the pharmacodynamic effect of alprazolam.
• To lessen the possibility of interdose symptoms, the times of administration should be distributed as evenly as possible throughout the waking hours, (i.e., administered three or four times daily).
• Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug.
• The dose should be advanced until an acceptable therapeutic response (i.e., a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained.
• Dose Maintenance For patients receiving doses greater than 4 mg per day, periodically reassess treatment and consider a reduction of dosage.
• In a controlled postmarketing dose-response study, patients treated with doses of alprazolam greater than 4 mg per day for 3 months were able to taper to 50% of their total daily maintenance dose without apparent loss of clinical benefit.
• Because of the danger of withdrawal,
• avoid abrupt discontinuation of treatment [see Warnings and Precautions ( 5.3 ), Drug Abuse and Dependence ( 9.3 )] .
• The necessary duration of treatment for panic disorder patients responding to alprazolam is unknown.
• After a period of extended freedom from 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.
• 2.3 Discontinuation or Dosage Reduction of Alprazolam Orally Disintegrating Tablets To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Alprazolam orally disintegrating tablets 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 ) and Drug Abuse and Dependence ( 9.3 )] .
• In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, there was no difference between the groups in the proportion of patients who tapered and completely discontinued treatment with alprazolam; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome.
• Reduce the dose 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.
• 2.4 Dosing in Special Populations In elderly patients, in patients with advanced liver disease, or in patients with debilitating disease (e.g., severe pulmonary disease), the usual starting dose is 0.25 mg, given two or three times daily.
• This may be gradually increased if needed and tolerated.
• The elderly may be especially sensitive to the effects of benzodiazepines.
• If adverse reactions occur at the recommended starting dose, the dose may be lowered.
• 2.5 Instructions to be Given to Patients for Use/Handling Alprazolam Orally Disintegrating Tablets Just prior to administration, with dry hands, remove the tablet from the blister.
• Immediately place the alprazolam orally disintegrating tablet on top of the tongue where it will disintegrate and be swallowed with saliva.
• Administration with liquid is not necessary.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Misuse and dependence

Quoted from the official label, section “Drug Abuse and Dependence”.

Use in children

Safety and effectiveness of alprazolam in individuals below 18 years of age have not been studied.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• The elderly may be more sensitive to the effects of benzodiazepines.
• They exhibit higher plasma alprazolam concentrations due to reduced clearance of the drug, compared with a younger population receiving the same doses.
• The smallest effective dose of alprazolam should be used in the elderly to preclude the development of ataxia and oversedation [see Clinical Pharmacology ( 12 ) and Dosage and Administration ( 2 )].
• Changes in the absorption, distribution, metabolism and excretion of benzodiazepines have been demonstrated in geriatric patients.
• A mean half-life of alprazolam of 16.3 hours has been observed in healthy elderly subjects (range:
• 9.0 to 26.9 hours, n=16) compared to 11.0 hours (range:
• 6.3 to 15.8 hours, n=16) in healthy adult subjects.

Quoted from the official label, section “Geriatric Use”.

Side effects

• Anxiety Disorder :
• The most common adverse reactions (greater than or equal to 5% and ~twice the rate of placebo) were sedation, and hypotension.
• Panic Disorder :
• The most common adverse reactions included sedation, impaired coordination, dysarthria, and increased libido ( 6.1 ).
• To report SUSPECTED ADVERSE REACTIONS, contact Par Health at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
• 6.1 Clinical Trial Experience The most commonly reported (greater than or equal to 5% and ~ twice the rate of placebo) adverse reactions with alprazolam treatment are:
• sedation, impaired coordination, dysarthria, and increased libido.
• The data cited in the two tables below are estimates of adverse reactions occurring in patients who participated in clinical trials under the following conditions:
• relatively short duration (four weeks) placebo-controlled clinical studies with dosages up to 4 mg per day of alprazolam (for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety) and short-term (up to ten weeks) placebo-controlled clinical studies with dosages up to 10 mg per day of alprazolam in patients with panic disorder, with or without agoraphobia.
• 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.
• Comparison of the cited figures, however, can provide the prescriber with some basis for estimating the relative contributions of drug and non-drug factors to the adverse reaction incidence in the population studied.
• Even this use must be approached cautiously, as a drug may relieve a symptom in one patient but induce it in others.
• (For example, an anxiolytic drug may relieve dry mouth [a symptom of anxiety] in some subjects but induce dry mouth in others.) Table 1:
• Adverse Reactions Reported in Placebo-Controlled Trials of Alprazolam in Generalized Anxiety Disorder (>2% and at a rate greater than placebo) GENERALIZED ANXIETY DISORDER Body System/Adverse Reaction Treatment-Emergent Symptom Incidence a ALPRAZOLAM (%) N=565 PLACEBO (%) N=505 Central Nervous System Sedation 41 22 Lightheadedness 21 19 Dizziness 2 1 Akathisia 2 1 Gastrointestinal Dry Mouth 15 13 Increased Salivation 4 2 Cardiovascular Hypotension 5 2 Cutaneous Dermatitis/Allergy 4 3 a Events reported by 1% or more of alprazolam patients are included.
• In addition to the relatively common (i.e., greater than 1%) adverse reactions described in the table above, 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.
• Table 2:
• Adverse Reactions Reported in Placebo-Controlled Trials of Alprazolam in Panic Disorder (>2 % and greater than placebo) PANIC DISORDER Body System/Adverse Reactions Treatment-Emergent Symptom Incidence a Central Nervous System ALPRAZOLAM (%) N=1388 PLACEBO (%) N=1231 Sedation 77 43 Fatigue and Tiredness 49 42 Impaired Coordination 40 18 Irritability 33 30 Memory Impairment 33 22 Cognitive Disorder 29 21 Dysarthria 23 6 Decreased Libido 14 8 Confusional State 10 8 Increased Libido 8 4 Change in Libido (Not Specified) 7 6 Disinhibition 3 2 Talkativeness 2 1 Derealization 2 1 Gastrointestinal Constipation 26 15 Increased Salivation 6 4 Cutaneous Rash 11 8 Other Increased Appetite 33 23 Decreased Appetite 28 24 Weight Gain 27 18 Weight Loss 23 17 Micturition Difficulties 12 9 Menstrual Disorders 10 9 Sexual Dysfunction 7 4 Incontinence 2 1 a Events reported by 1% or more of alprazolam patients are included.
• In addition to the relatively common (i.e., greater than 1%) adverse reactions described in the table above, the following adverse reactions have been reported in association with the use of alprazolam:
• seizures, hallucinations, depersonalization, taste alterations, diplopia, elevated bilirubin, elevated hepatic enzymes, and jaundice.
• Panic disorder has been associated with primary and secondary major depressive disorders and increased reports of suicide among untreated patients [see Warnings and Precautions ( 5.4 )].
• 6.2 Postmarketing Experience The following adverse reactions have been identified during postmarketing use of alprazolam.
• 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.
• Reported events include:
• liver enzyme elevations, hepatitis, hepatic failure, Stevens-Johnson syndrome, hyperprolactinemia, gynecomastia, and galactorrhea.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling (Medication Guide).
• Risks from Concomitant Use with Opioids Inform patients and caregivers that potentially fatal additive effects may occur if alprazolam is used with opioids and not to use such drugs concomitantly unless supervised by a health care provider [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7.1 ) ].
• Abuse, Misuse, and Addiction Inform patients that the use of Alprazolam orally disintegrating tablets, 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 ) and Drug Abuse and Dependence ( 9.2 )].
• Withdrawal Reactions Inform patients that the continued use of Alprazolam orally disintegrating tablets may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of Alprazolam orally disintegrating tablets 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 alprazolam orally disintegrating tablets may require a slow taper [see Warnings and Precautions ( 5.3 ) and Drug Abuse and Dependence ( 9.3 )] .
• Use/Handling Alprazolam Orally Disintegrating Tablets To assure safe and effective use of benzodiazepines, all patients prescribed alprazolam orally disintegrating tablets should be provided with the following guidance.
• Do not remove Alprazolam orally disintegrating tablets from the blister until just prior to dosing.
• With dry hands, open the blister, remove the tablet, and immediately place on the tongue to dissolve and be swallowed with the saliva.
• The tablet may also be taken with water.
• Store at room temperature in a dry place.
• Protect from moisture.
• Inform your physician about any alcohol consumption and medicine
• you are taking now, including medication you may buy without a prescription.
• Alcohol should generally not be used during treatment with benzodiazepines.
• Alprazolam orally disintegrating tablets are not recommended for use in pregnancy.
• Therefore, inform your physician
• if you are pregnant,
• if you are planning to have a child, or
• if you become pregnant while
• you are taking this medication.
• Inform your physician if you are nursing.
• Until you experience how this medication affects you, do not drive a car or operate potentially dangerous machinery, etc.
• Do not increase the dose even
• if you think the medication “does not work anymore” without consulting your physician.
• Benzodiazepines, even after relatively short-term use at the doses recommended, may produce emotional and/or physical dependence.
• Do not stop taking this medication abruptly or decrease the dose without consulting your physician, since withdrawal symptoms can occur even after relatively short-term use at the doses recommended.
• You should follow a gradual dosage tapering schedule.
• Pregnancy:
• Advise pregnant females that use of Alprazolam orally disintegrating tablets late in pregnancy can result in sedation, (respiratory depression, withdrawal symptoms, 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 Alprazolam orally disintegrating tablets during pregnancy [see Use in Specific Populations ( 8.1 )] . 10.
• Phenylketonurics:
• Phenylketonuric patients should be informed that alprazolam orally disintegrating tablets contain phenylalanine (a component of aspartame).
• Each 0.25 mg, 0.5 mg, 1 mg and 2 mg orally disintegrating tablet contains 2.52 mg, 5.04 mg, 5.04 mg and 10.08 mg of phenylalanine, respectively [see Description ( 11.1 )] . 11.
• Lactation:
• Advise patients that breastfeeding is not recommended during treatment with Alprazolam orally disintegrating tablets [see Use in Specific Populations ( 8.2 )] .
• To obtain a printable copy of the Medication Guide, visit www.parhealth.com/products Manufactured for:
• Par Health USA Rochester, MI 48307 U.S.A.
• Made in India Neutral Code:
• TN/DRUGS/TN00002121 © 2026 Par Health, Inc. or one of its affiliates.
• OS110C-01-74-03 Revised: 02/2026

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS 0.25 mg, 0.5 mg, 1.0 mg, and 2.0 mg scored orally disintegrating tablets, USP. 0.25 mg, 0.5 mg, 1 mg, or 2 mg scored orally disintegrating tablets USP ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Alprazolam orally disintegrating tablets, USP 0.25 mg are white to off-white, round, scored, flat face, beveled edge tablets debossed ‘110’ on the scored side and plain on the other.
• They are supplied as follows:
• Blisters of 10 x 10 NDC 49884-110-74 Alprazolam orally disintegrating tablets, USP 0.5 mg are white to off-white, round, scored, flat face, beveled edge tablets debossed ‘111’ on the scored side and plain on the other.
• They are supplied as follows:
• Blisters of 10 x 10 NDC 49884-111-74 Alprazolam orally disintegrating tablets, USP 1 mg are white to off-white, round, scored, flat face, beveled edge tablets debossed ‘213’ on the scored side and plain on the other.
• They are supplied as follows:
• Blisters of 10 x 10 NDC 49884-213-74 Alprazolam orally disintegrating tablets, USP 2 mg are white to off-white, round, scored, flat face, beveled edge tablets debossed ‘214’ on the scored side and plain on the other.
• They are supplied as follows:
• Blisters of 10 x 10 NDC 49884-214-74 Storage
• Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86ºF) [See USP Controlled Room Temperature].
• Protect from moisture.
• Dispense in tight, light-resistant containers as defined in the USP.
• Keep container tightly closed.

Quoted from the official label, section “How Supplied”.

What is in it

• Alprazolam orally disintegrating tablets, USP contain alprazolam, USP which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds.
• Alprazolam orally disintegrating tablets, USP are an orally administered formulation of alprazolam, USP which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing.
• The chemical name of alprazolam, USP is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine.
• The molecular formula is C 17 H 13 CIN 4 and the molecular weight is 308.76.
• The structural formula is:
• Alprazolam, USP is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. this is the structure
• 11.1 Alprazolam Orally Disintegrating Tablets, USP Each orally disintegrating tablet contains either 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam, USP and the following inactive ingredients:
• aspartame, crospovidone, basic butylated methacrylate copolymer, magnesium stearate, mannitol, silicon dioxide, sorbitol, talc, xylitol, natural peppermint flavor, artificial vanillin flavor.

Quoted from the official label, section “Description”.

Ingredients people check for

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Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

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Same active substance

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