MedPath

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

A Study to Assess the Cognitive Effects of Fesoterodine in Elderly Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-07-13
Last Posted Date
2012-06-28
Lead Sponsor
Pfizer
Target Recruit Count
20
Registration Number
NCT01161472
Locations
🇺🇸

Pfizer Investigational Site, Overland Park, Kansas, United States

A Study Of Two Oral Preparations Of 2 Mg Alprazolam In Healthy Volunteers Under Fasting Conditions

Phase 1
Withdrawn
Conditions
Healthy
Interventions
First Posted Date
2010-01-11
Last Posted Date
2021-01-28
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Registration Number
NCT01046162

Bioequivalence of a New Sublingual and a Reference Alprazolam Immediate Release Tablet Formulation

First Posted Date
2009-12-09
Last Posted Date
2021-01-28
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Registration Number
NCT01027689

A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users

Phase 1
Completed
Conditions
Alzheimer's Disease
Huntington's Disease
Interventions
First Posted Date
2009-09-11
Last Posted Date
2013-04-02
Lead Sponsor
Pfizer
Target Recruit Count
36
Registration Number
NCT00975481

A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder

Phase 2
Completed
Conditions
Generalized Anxiety Disorder
Interventions
First Posted Date
2009-06-16
Last Posted Date
2010-02-19
Lead Sponsor
Pfizer
Target Recruit Count
222
Registration Number
NCT00921063

To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 1 mg

First Posted Date
2009-06-04
Last Posted Date
2017-03-28
Lead Sponsor
Sandoz
Target Recruit Count
30
Registration Number
NCT00913341

To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 2 mg

Phase 1
Completed
Conditions
Anxiety
Interventions
First Posted Date
2009-06-03
Last Posted Date
2017-03-28
Lead Sponsor
Sandoz
Target Recruit Count
26
Registration Number
NCT00912145

Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-04-09
Last Posted Date
2009-11-25
Lead Sponsor
Orion Corporation, Orion Pharma
Target Recruit Count
18
Registration Number
NCT00878865
Locations
🇫🇮

Orion Pharma phase I unit, Espoo, Finland

Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-04-09
Last Posted Date
2009-11-25
Lead Sponsor
Orion Corporation, Orion Pharma
Target Recruit Count
18
Registration Number
NCT00878514
Locations
🇫🇮

Orion Pharma Phase I unit, Espoo, Finland

Bioequivalence Of A Test Alprazolam Sublingual Formulation Compared To A Commercial Sublingual Formulation

First Posted Date
2009-04-08
Last Posted Date
2021-01-28
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Registration Number
NCT00877955
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