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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/13 | Phase 1 | Not yet 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 |
|---|---|---|---|---|---|
| Alprazolam Capsules | 国药准字H20010588 | 化学药品 | 胶囊剂 | 5/18/2020 | |
| Alprazolam Tablets | 国药准字H50020312 | 化学药品 | 片剂 | 8/18/2020 | |
| Alprazolam Tablets | 国药准字H20194039 | 化学药品 | 片剂 | 5/8/2024 | |
| Alprazolam Tablets | 国药准字H22026350 | 化学药品 | 片剂 | 1/19/2020 | |
| Alprazolam Tablets | 国药准字H35020696 | 化学药品 | 片剂 | 9/23/2020 | |
| Alprazolam Tablets | 国药准字H14021412 | 化学药品 | 片剂 | 5/20/2020 | |
| Alprazolam Tablets | 国药准字H14021188 | 化学药品 | 片剂 | 9/1/2020 | |
| Alprazolam Tablets | 国药准字H44022483 | 化学药品 | 片剂 | 4/2/2020 | |
| Alprazolam Tablets | 国药准字H22021426 | 化学药品 | 片剂 | 4/8/2020 | |
| Alprazolam Tablets | 国药准字H13020639 | 化学药品 | 片剂 | 5/26/2020 |
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 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| KALMA 0.5 alprazolam 0.5mg tablet blister pack | 385851 | Medicine | A | 8/31/2022 | |
| GenRx Alprazolam | 80934 | Medicine | A | 11/26/2001 | |
| KALMA 0.5 alprazolam 0.5mg tablet bottle | 46837 | Medicine | A | 10/22/1993 | |
| ALPRAX 0.5 alprazolam 0.5mg tablet bottle | 82639 | Medicine | A | 7/30/2002 | |
| Alprazolam Tablet 1 mg Bulk | 341274 | Medicine | A | 8/11/2020 | |
| ALPRAZOLAM SANDOZ alprazolam 0.5 mg tablet blister pack | 387466 | Medicine | A | 6/2/2023 | |
| KALMA 2 alprazolam 2mg tablet blister pack | 385853 | Medicine | A | 8/31/2022 | |
| ALPRAZOLAM SANDOZ alprazolam 0.25 mg tablet blister pack | 387465 | Medicine | A | 6/2/2023 | |
| ALPRAZOLAM SANDOZ alprazolam 1 mg tablet blister pack | 387290 | Medicine | A | 6/2/2023 | |
| Alprazolam Tablet 0.25 mg Bulk | 341272 | Medicine | A | 8/11/2020 |
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