ALPRAZOLAM
Alprazolam tablets are indicated for the: acute treatment of generalized anxiety disorder (GAD) in adults. treatment of panic disorder (PD), with or without agoraphobia in adults. Treatment of panic disorder with or without agoraphobia in adults.
Details
- Status
- Discontinued
- First Approved
- 1993-10-19
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE, TABLET, TABLET, ORALLY DISINTEGRATING, CONCENTRATE, SOLUTION
Companies
ALPRAZOLAM Approval History
What ALPRAZOLAM Treats
32 FDA approvalsOriginally approved for its first indication in 1993 . Covers 32 distinct patient populations.
- Other (32)
Other
(32 approvals)- • Approved indication (Oct 1993)
- • Approved indication (Oct 1993)
- • Approved indication (Jan 1994)
- • Approved indication (Feb 1994)
- • Approved indication (Jul 1994)
- • Approved indication (Aug 1995)
- • Approved indication (Dec 1995)
- • Approved indication (Jan 1997)
- • Approved indication (Mar 1998)
- • Approved indication (Jan 2006)Letter
- • Approved indication (Jun 2006)
- • Approved indication (Jul 2006)
- • Approved indication (Jan 2007)
- • Approved indication (Jan 2007)
- • Approved indication (Feb 2007)
- • Approved indication (Feb 2007)
- • Approved indication (May 2007)
- • Approved indication (Oct 2007)
- • Approved indication (May 2008)
- • Approved indication (Sep 2008)
- • Approved indication (Oct 2008)
- • Approved indication (Nov 2008)
- • Approved indication (Jan 2009)Letter
- • Approved indication (Mar 2010)
- • Approved indication (May 2010)
- • Approved indication (Jun 2010)
- • Approved indication (Sep 2010)
- • Approved indication (Jun 2011)
- • Approved indication (Sep 2011)
- • Approved indication (Apr 2015)
- • Approved indication (Jul 2015)
- • Approved indication (Jul 2018)
ALPRAZOLAM Boxed Warning
RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for 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 [see Warnings and Prec...
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for 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 [see Warnings and Precautions (5.1) , Drug Interactions (7.1) ] . The use of benzodiazepines, including alprazolam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing alprazolam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction [see Warnings and Precautions (5.2) ] . The continued use of benzodiazepines, including alprazolam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of alprazolam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue alprazolam or reduce the dosage [see Dosage and Administration (2.2) , Warnings and Precautions (5.3) ] . WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS See full prescribing information for complete boxed warning. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatmen
Clinical Trial Registry
24 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07154147 CatNAPS-2 | 25-43837 | Ph 4 | completed | Oral vs IV Sedation for Cataract Surgery in Older Adults |
| NCT05006079 MAP | IRB-21-07-3844 | Ph 2 | recruiting | Opioid/Benzodiazepine Polydrug Abuse: Aim 3 |
| NCT06757140 | 97946 R01DA016718 | Ph 1, Ph 2 | recruiting | Opioid Drug Interaction Study |
| NCT05602818 results posted | TAK-935-1012 | Ph 1 | completed | A Study of Soticlestat in Healthy Adult Nondependent Recreational Drug Users With Central Nervous System (CNS) Depressant Experience |
| NCT03509285 | YKP3089C024 | Ph 1 | completed | A Study of the Abuse Liability Potential of Cenobamate in Recreational Drug Users |
| NCT06357104 | SCI-CT-0001 | Ph 4 | completed | Detoxification From the Lipid Tract |
| NCT04802746 | UP0099 | Ph 1 | completed | A Study to Assess the Pulmonary Safety of Staccato Alprazolam in Healthy Study Participants and in Study Participants With Mild Asthma |
| NCT03635437 | Regenerate-1 (G/P2/18/1) | Ph 1, Ph 2 | completed | Evaluation of Safety and Diabetes Status Upon Oral Treatment With GABA in Patients With Longstanding Type-1 Diabetes |
| NCT04857307 | UP0100 | Ph 1 | completed | A Study to Assess the Pharmacokinetics (PK) and Safety of Staccato Alprazolam in Adolescent Study Participants With Epilepsy |
| NCT00803400 AEIPDT results posted | UDHFMEDUBA0709 | Ph 4 | completed | Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment |
| NCT04782388 | UP0101 | Ph 1 | completed | Study to Assess the Safety, Tolerability, And Pharmacokinetics of Staccato Alprazolam in Healthy Japanese, Chinese, and Caucasian Participants |
| NCT00810316 | A6131015 | Ph 1 | completed | Evaluate Pharmacokinetics Of Two Different Pharmaceutical Oral Formulations Of Alprazolam And A Clonazepam Tablet In Mexican Healthy Population |
| NCT01046162 | A6131021 | Ph 1 | withdrawn | A Study Of Two Oral Preparations Of 2 Mg Alprazolam In Healthy Volunteers Under Fasting Conditions |
| NCT03286218 results posted | 16853 H8H-MC-LAHB | Ph 1 | completed | A Study of the Abuse Potential of Lasmiditan in Participants Who Are Recreational Drug Users |
| NCT03012334 results posted | 16883 COL MIG-106, H8H-CD-LAHG | Ph 1 | completed | The Effects of Lasmiditan on Simulated Driving Performance - Healthy Participants |
| NCT03814733 | RAP-PK-18 | Ph 1 | completed | Assessment of Effect of Rapastinel on Driving Performance |
| NCT03398083 | NIDA-CBD-Phase1-001 | Ph 1 | completed | Evaluation of the Effects of Cannabidiol (CBD) Compared to Delta-9-Tetrahydrocannabinol (THC) and Alprazolam |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT01546896 | bsp2010 | Ph 4 | withdrawn | Effects of Buspar on Depressive Symptom Improvement and Neuroprotection in Patients With Anxiety Disorder |
| NCT01549691 PREMED | PHRC 2011-20 2011-002553-65 | Ph 4 | completed | Reassessment of Premedication in Surgery |
| NCT00975481 results posted | B1451037 | Ph 1 | completed | A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users |
| NCT01546090 | 390553 390553, 390553 | Ph 4 | completed | Effect of Alprazolam on the Success of Inferior Alveolar Nerve (IAN) Block |
| NCT00878514 | 0228015 | Ph 1 | completed | Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions |
| NCT00878865 | 0228014 | Ph 1 | completed | Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ALPRAZOLAM FDA Label Details
Indications & Usage
Alprazolam tablets are indicated for the: acute treatment of generalized anxiety disorder (GAD) in adults. treatment of panic disorder (PD), with or without agoraphobia in adults. Alprazolam is a benzodiazepine indicated for the: Acute treatment of generalized anxiety disorder in adults. Treatment of panic disorder with or without agoraphobia in adults.
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.