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 Relative Bioavailability Study of Alprazolam 3 mg ER Tablets Under Fasting Conditions
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2009-03-19
- Last Posted Date
- 2010-08-17
- Lead Sponsor
- Actavis Inc.
- Target Recruit Count
- 40
- Registration Number
- NCT00865761
- Locations
- 🇺🇸
PRACS Institute, Ltd., Fargo, North Dakota, United States
A Relative Bioavailability Study of Alprazolam 3 mg Extended Release Tablets Under Non-fasting Conditions
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2009-03-19
- Last Posted Date
- 2010-08-17
- Lead Sponsor
- Actavis Inc.
- Target Recruit Count
- 40
- Registration Number
- NCT00865657
- Locations
- 🇺🇸
PRACS Institute, Ltd., Fargo, North Dakota, United States
Bioequivalence of Alprazolam Sublingual vs Oral Tablets
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2009-03-11
- Last Posted Date
- 2021-01-28
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Target Recruit Count
- 23
- Registration Number
- NCT00860119
- Locations
- 🇮🇳
Pfizer Investigational Site, Ahmedabad, Gujarat, India
Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Non-fasting Conditions
- First Posted Date
- 2009-01-27
- Last Posted Date
- 2024-08-20
- Lead Sponsor
- Teva Pharmaceuticals USA
- Target Recruit Count
- 36
- Registration Number
- NCT00830024
- Locations
- 🇺🇸
PRACS Institute, Ltd., Fargo, North Dakota, United States
Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Fasting Conditions
- First Posted Date
- 2009-01-27
- Last Posted Date
- 2009-07-21
- Lead Sponsor
- Teva Pharmaceuticals USA
- Target Recruit Count
- 32
- Registration Number
- NCT00829426
- Locations
- 🇺🇸
PRACS Institute, Ltd., Fargo, North Dakota, United States
Evaluate Pharmacokinetics Of Two Different Pharmaceutical Oral Formulations Of Alprazolam And A Clonazepam Tablet In Mexican Healthy Population
- Conditions
- Pharmacokinetics
- Interventions
- First Posted Date
- 2008-12-18
- Last Posted Date
- 2021-01-28
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Target Recruit Count
- 24
- Registration Number
- NCT00810316
- Locations
- 🇲🇽
Pfizer Investigational Site, Col. Arenal Tepepan, Mexico D.F., Mexico
Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment
- Conditions
- Panic Disorder
- Interventions
- First Posted Date
- 2008-12-05
- Last Posted Date
- 2021-08-19
- Lead Sponsor
- University of Buenos Aires
- Target Recruit Count
- 150
- Registration Number
- NCT00803400
- Locations
- 🇦🇷
Psychiatry Academic Unit at J.A.Fernandez Hospital, University of Buenos Aires Medicine School Department of Mental Health, Buenos Aires, Capital Federal, Argentina
Drug Treatment Validation of Functional Magnetic Resonance Imaging in Generalized Anxiety Disorder
- Conditions
- Generalized Anxiety Disorder
- Interventions
- Drug: Placebo
- First Posted Date
- 2008-04-21
- Last Posted Date
- 2019-07-25
- Lead Sponsor
- University of California, San Diego
- Target Recruit Count
- 32
- Registration Number
- NCT00662259
- Locations
- 🇺🇸
University of California, San Diego, San Diego, California, United States
Fed Study of Alprazolam Extended-release Tablets 3 mg to Xanax XR® Tablets 3 mg
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2008-04-01
- Last Posted Date
- 2024-04-24
- Lead Sponsor
- Mylan Pharmaceuticals Inc
- Target Recruit Count
- 21
- Registration Number
- NCT00650299
- Locations
- 🇺🇸
Kendle International Inc., Morgantown, West Virginia, United States
Fasting Study of Alprazolam Extended-Release Tablets 3 mg to Xanax XR® Tablets 3 mg
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2008-04-01
- Last Posted Date
- 2024-04-24
- Lead Sponsor
- Mylan Pharmaceuticals Inc
- Target Recruit Count
- 21
- Registration Number
- NCT00647634
- Locations
- 🇺🇸
Kendle International Inc., Morgantown, West Virginia, United States
Drug Development Updates
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