Overview
Alprazolam is a triazolobenzodiazepine indicated for the treatment of anxiety and panic disorders. It is mainly metabolized by CYP3As and so is contraindicated with CYP3A inhibitors like ketoconazole and itraconazole. Benzodiazepine treatment should be stopped gradually by tapering down a patient's dose to avoid withdrawal symptoms. Alprazolam's adverse effects are generally related to the sedation it can cause. Alprazolam has been mixed with alcohol as a drug of abuse to potentiate the sedative effects of the drug which may lead to coma and death. Alprazolam was given FDA approval on October 16, 1981.
Indication
Alprazolam is indicated for the acute treatment of generalized anxiety disorder in adults. Alprazolam is also indicated, either as a standard or extended-release formulation, for the treatment of panic disorder with or without agoraphobia in adults. Alprazolam may also be prescribed off-label for insomnia, premenstrual syndrome, and depression.
Associated Conditions
- Generalized Anxiety Disorder
- Panic Disorder
Research Report
Comprehensive Monograph on Alprazolam (DB00404)
I. Introduction and Executive Summary
Alprazolam is a potent, fast-acting, small molecule drug belonging to the triazolobenzodiazepine class of central nervous system (CNS) depressants.[1] Since its approval by the U.S. Food and Drug Administration (FDA) in 1981, it has become one of the most widely prescribed psychotropic medications in the United States, primarily under the brand name Xanax.[3] Developed by the Upjohn Company, alprazolam was introduced as a therapeutic agent for the management of anxiety disorders and panic disorder, positioned as a potentially safer and more effective alternative to older sedative-hypnotics like barbiturates.[5]
This report provides a comprehensive, evidence-based analysis of alprazolam, exploring the profound dichotomy that defines its clinical profile: its established therapeutic utility versus its significant and often underestimated risks. The central theme of this monograph is the critical examination of this paradox. While the drug offers rapid and effective relief for debilitating anxiety and panic for many patients, it carries a high liability for misuse, physical dependence, and a uniquely severe withdrawal syndrome that can be life-threatening.[7] Furthermore, its pharmacokinetic profile makes it highly susceptible to dangerous drug interactions, a risk magnified by its widespread use in a polymedicated population.[10]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/06/13 | Phase 1 | Recruiting | |||
2025/03/13 | Phase 4 | Recruiting | |||
2025/02/14 | Not Applicable | Recruiting | |||
2025/01/03 | Phase 1 | Recruiting | Shanna Babalonis, PhD | ||
2024/04/10 | Phase 4 | Completed | Pachankis, Yang I., M.D. | ||
2024/03/05 | N/A | Recruiting | |||
2023/10/24 | Phase 4 | Completed | |||
2022/11/23 | Phase 1 | Completed | |||
2022/11/02 | Phase 1 | Completed | |||
2021/10/14 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
NuCare Pharmaceuticals,Inc. | 68071-2966 | ORAL | 1 mg in 1 1 | 11/29/2023 | |
Proficient Rx LP | 71205-652 | ORAL | 0.5 mg in 1 1 | 4/1/2022 | |
Blenheim Pharmacal, Inc. | 10544-106 | ORAL | 1 mg in 1 1 | 5/28/2013 | |
Natco Pharma USA LLC | 69339-202 | ORAL | 2 mg in 1 1 | 9/7/2023 | |
medsource pharmaceuticals | 45865-993 | ORAL | 0.5 mg in 1 1 | 12/30/2019 | |
Bryant Ranch Prepack | 71335-1669 | ORAL | 0.5 mg in 1 1 | 4/30/2021 | |
Direct_Rx | 61919-379 | ORAL | 0.25 mg in 1 1 | 9/18/2019 | |
Physicians Total Care, Inc. | 54868-2930 | ORAL | 0.5 mg in 1 1 | 9/25/2012 | |
Contract Pharmacy Services-PA | 67046-965 | ORAL | 1 mg in 1 1 | 4/26/2010 | |
Preferred Pharmaceuticals Inc. | 68788-7595 | ORAL | 0.5 mg in 1 1 | 1/24/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
XANAX TABLET 0.5 mg | SIN01985P | TABLET, FILM COATED | 0.5 mg | 6/23/1988 | |
XANAX TABLET 0.25 mg | SIN01984P | TABLET, FILM COATED | 0.25 mg | 6/23/1988 | |
XANAX XR EXTENDED-RELEASE TABLET 0.5 mg | SIN09173P | TABLET, SUGAR COATED | 0.5 mg | 1/24/1997 | |
ZACETIN TABLET 0.25 mg | SIN10458P | TABLET | 0.25 mg | 11/20/1998 | |
XANAX XR EXTENDED-RELEASE TABLET 1mg | SIN09175P | TABLET, SUGAR COATED | 1 mg | 1/24/1997 | |
APO-ALPRAZ TABLET 0.5 mg | SIN07871P | TABLET | 0.5 mg | 10/6/1994 | |
APO-ALPRAZ TABLET 0.25 mg | SIN07872P | TABLET | 0.25 mg | 10/6/1994 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
XANAX TAB 0.5MG | N/A | N/A | N/A | 6/10/1982 | |
KALMA TAB 0.25MG | N/A | N/A | N/A | 10/31/1996 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
KALMA 0.5 alprazolam 0.5mg tablet blister pack | 385851 | Medicine | A | 8/31/2022 | |
GenRx Alprazolam | 80934 | Medicine | A | 11/26/2001 | |
KALMA 0.5 alprazolam 0.5mg tablet bottle | 46837 | Medicine | A | 10/22/1993 | |
ALPRAX 0.5 alprazolam 0.5mg tablet bottle | 82639 | Medicine | A | 7/30/2002 | |
Alprazolam Tablet 1 mg Bulk | 341274 | Medicine | A | 8/11/2020 | |
ALPRAZOLAM SANDOZ alprazolam 0.5 mg tablet blister pack | 387466 | Medicine | A | 6/2/2023 | |
KALMA 2 alprazolam 2mg tablet blister pack | 385853 | Medicine | A | 8/31/2022 | |
ALPRAZOLAM SANDOZ alprazolam 0.25 mg tablet blister pack | 387465 | Medicine | A | 6/2/2023 | |
ALPRAZOLAM SANDOZ alprazolam 1 mg tablet blister pack | 387290 | Medicine | A | 6/2/2023 | |
Alprazolam Tablet 0.25 mg Bulk | 341272 | Medicine | A | 8/11/2020 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
PRO-ALPRAZOLAM | PRO DOC LIMITEE | 02248706 | Tablet - Oral | 1 MG | 4/1/2004 |
XANAX | BGP Pharma ULC | 00548367 | Tablet - Oral | 0.5 MG | 12/31/1981 |
ALPRAZOLAM TABLETS 0.25 | prempharm inc | 02230074 | Tablet - Oral | 0.25 MG | 12/23/1996 |
RIVA-ALPRAZOLAM | laboratoire riva inc. | 02404877 | Tablet - Oral | 0.25 MG | 11/20/2014 |
NTP-ALPRAZOLAM | teva canada limited | 02346990 | Tablet - Oral | 0.25 MG | N/A |
NU-ALPRAZ TAB 0.5MG | nu-pharm inc | 01913247 | Tablet - Oral | .5 MG | 12/31/1991 |
RIVA-ALPRAZOLAM | laboratoire riva inc. | 02404893 | Tablet - Oral | 1 MG | 11/20/2014 |
JAMP ALPRAZOLAM | 02397056 | Tablet - Oral | 1 MG | N/A | |
JAMP ALPRAZOLAM | 02397048 | Tablet - Oral | 0.5 MG | N/A | |
APO-ALPRAZ | 00865397 | Tablet - Oral | 0.25 MG | 12/31/1990 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
TRANKIMAZIN RETARD 1 mg COMPRIMIDOS | 61151 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized | |
ALPRAZOLAM NORMON 1 mg COMPRIMIDOS EFG | Laboratorios Normon S.A. | 63248 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
ALPRAZOLAM TARBIS 2 mg COMPRIMIDOS EFG | Tarbis Farma S.L. | 64431 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
ALPRAZOLAM STADA 0,5 mg COMPRIMIDOS EFG | Laboratorio Stada S.L. | 63463 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
ALPRAZOLAM CINFA, 2 mg COMPRIMIDOS EFG | Laboratorios Cinfa S.A. | 62789 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
ALPRAZOLAM SUN 0,25 mg COMPRIMIDOS EFG | 61882 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Not Commercialized | |
ALPRAZOLAM STADAFARMA 0,5 MG COMPRIMIDOS EFG | Laboratorio Stada S.L. | 89268 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Not Commercialized |
ALPRAZOLAM KERN PHARMA 0,5 mg COMPRIMIDOS EFG | 63280 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized | |
ALPRAZOLAM TARBIS 0,5 mg, COMPRIMIDOS EFG | Tarbis Farma S.L. | 64429 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
ALPRAZOLAM MABO 0,5 mg COMPRIMIDOS EFG | Mabo Farma S.A. | 63340 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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