Overview
A benzodiazepine with anticonvulsant, hypnotic, and muscle relaxant properties. It has been shown in some cases to be more potent than diazepam or nitrazepam.
Indication
For the short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings.
Associated Conditions
- Insomnia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/01/19 | Not Applicable | Not yet recruiting | |||
2022/07/11 | Not Applicable | Completed | |||
2019/06/25 | Phase 4 | UNKNOWN | The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine | ||
2009/08/11 | Phase 4 | Completed | |||
2006/07/04 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Dr. Reddy's Labratories Inc. | 75907-029 | ORAL | 2 mg in 1 1 | 2/5/2024 | |
| Novitium Pharma LLC | 70954-481 | ORAL | 2 mg in 1 1 | 11/23/2022 | |
| Mayne Pharma | 51862-074 | ORAL | 2 mg in 1 1 | 12/23/2022 | |
| Actavis Pharma, Inc. | 0591-0745 | ORAL | 2 mg in 1 1 | 11/14/2022 | |
| Rebel Distributors Corp | 21695-220 | ORAL | 2 mg in 1 1 | 11/23/2010 | |
| Mayne Pharma | 51862-073 | ORAL | 1 mg in 1 1 | 12/23/2022 | |
| Dr. Reddy's Labratories Inc. | 75907-028 | ORAL | 1 mg in 1 1 | 2/5/2024 | |
| Novitium Pharma LLC | 70954-480 | ORAL | 1 mg in 1 1 | 11/23/2022 | |
| Actavis Pharma, Inc. | 0591-0744 | ORAL | 1 mg in 1 1 | 11/14/2022 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| PROSOM TAB 2MG | ABBOTT LABORATORIES, LIMITED | 02015102 | Tablet - Oral | 2 MG / TAB | 12/31/1993 |
| PROSOM TAB 1MG | ABBOTT LABORATORIES, LIMITED | 02016060 | Tablet - Oral | 1 MG / TAB | 12/31/1993 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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