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Alprazolam

Generic Name
Alprazolam
Brand Names
Niravam, Xanax
Drug Type
Small Molecule
Chemical Formula
C17H13ClN4
CAS Number
28981-97-7
Unique Ingredient Identifier
YU55MQ3IZY

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

Published: Aug 4, 2025

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]

Continue reading the full research report

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

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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