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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
Background

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

Fasting Study of Alprazolam Extended-Release Tablets 1 mg to Xanax XR Tablets 1 mg

First Posted Date
2008-04-01
Last Posted Date
2024-04-24
Lead Sponsor
Mylan Pharmaceuticals Inc
Target Recruit Count
24
Registration Number
NCT00647894
Locations
🇺🇸

Kendle International Inc., Morgantown, West Virginia, United States

A Study to Assess the Long-term Use of Alprazolam Extended Release (XL) in the Treatment of Adolescents With Panic Disorder

Phase 4
Terminated
Conditions
Panic Disorder
Interventions
Other: placebo
First Posted Date
2008-03-13
Last Posted Date
2021-01-28
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Target Recruit Count
3
Registration Number
NCT00635076
Locations
🇺🇸

Pfizer Investigational Site, Middleton, Wisconsin, United States

A Study To Assess the Safety of Extended Release Alprazolam for the Treatment of Adolescents With Panic Disorder or Anxiety With Panic Attacks

Phase 4
Terminated
Conditions
Panic Disorder
Interventions
First Posted Date
2008-03-13
Last Posted Date
2021-01-28
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Target Recruit Count
49
Registration Number
NCT00634790
Locations
🇺🇸

Pfizer Investigational Site, Middleton, Wisconsin, United States

A Study to Evaluate the Use of Extended Release Alprazolam in the Treatment of Adolescents With Panic Disorder

Phase 4
Terminated
Conditions
Panic Disorder
Interventions
Other: placebo
First Posted Date
2008-03-13
Last Posted Date
2021-01-28
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Target Recruit Count
16
Registration Number
NCT00635531
Locations
🇺🇸

Pfizer Investigational Site, Middleton, Wisconsin, United States

Staccato Alprazolam Abuse Liability

Phase 1
Completed
Conditions
Abuse Liability of Staccato Alprazolam
Interventions
Drug: Inhaled placebo + oral placebo
Drug: Inhaled alprazolam 0.5 mg
Drug: Oral alprazolam 4 m
Drug: Oral alprazolam 2 mg qualifying session
Drug: Oral placebo qualifying session
First Posted Date
2008-01-29
Last Posted Date
2020-01-02
Lead Sponsor
Alexza Pharmaceuticals, Inc.
Target Recruit Count
31
Registration Number
NCT00603980
Locations
🇺🇸

Johns Hopkins University School of Medicine, Baltimore, Maryland, United States

Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2

Not Applicable
Completed
Conditions
Type 1 Diabetes
Interventions
Other: control group
First Posted Date
2008-01-14
Last Posted Date
2014-12-11
Lead Sponsor
Vanderbilt University
Target Recruit Count
56
Registration Number
NCT00592332
Locations
🇺🇸

Vanderbilt University, Nashville, Tennessee, United States

Evaluation Of PF-00572778 And Alprazolam On Naloxone Challenge In Healthy Subjects

Phase 1
Terminated
Conditions
Healthy
Interventions
First Posted Date
2007-12-24
Last Posted Date
2009-09-14
Lead Sponsor
Pfizer
Target Recruit Count
47
Registration Number
NCT00580190
Locations
🇺🇸

Pfizer Investigational Site, New Haven, Connecticut, United States

Mechanisms of Hypoglycemia Associated Autonomic Dysfunction Question 2

Early Phase 1
Completed
Conditions
Type 1 Diabetes
Interventions
Drug: Placebo
First Posted Date
2007-12-17
Last Posted Date
2019-09-12
Lead Sponsor
University of Maryland, Baltimore
Target Recruit Count
14
Registration Number
NCT00574639
Locations
🇺🇸

University of Maryland, Baltimore, Baltimore, Maryland, United States

A Study To Compare The Putative Anxiolytic Effect Of 2 New Drugs In Subjects With Social Anxiety Disorder

Phase 1
Completed
Conditions
Social Phobia
Interventions
Drug: GW876008 tablet
Drug: GSK561679 tablet
Drug: Placebo
First Posted Date
2007-11-07
Last Posted Date
2017-08-04
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
35
Registration Number
NCT00555139
Locations
🇪🇸

GSK Investigational Site, Terrassa - Barcelona, Spain

Staccato Alprazolam in Panic Attack

Phase 2
Completed
Conditions
Treatment of Induced Panic Attack
Interventions
First Posted Date
2007-05-23
Last Posted Date
2017-06-16
Lead Sponsor
Alexza Pharmaceuticals, Inc.
Target Recruit Count
49
Registration Number
NCT00477451
Locations
🇺🇸

SUNY Downstate Medical Center, Brooklyn, New York, United States

🇺🇸

New York State Psychiatric Institute, New York, New York, United States

🇺🇸

Mt. Sinai School Of Medicine, New York, New York, United States

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