Overview
Lorazepam is a short-acting and rapidly cleared benzodiazepine used commonly as a sedative and anxiolytic. It was developed by DJ Richards, presented and marketed initially by Wyeth Pharmaceuticals in the USA in 1977. The first historic FDA label approval is reported in 1985 by the company Mutual Pharm.
Background
Lorazepam is a short-acting and rapidly cleared benzodiazepine used commonly as a sedative and anxiolytic. It was developed by DJ Richards, presented and marketed initially by Wyeth Pharmaceuticals in the USA in 1977. The first historic FDA label approval is reported in 1985 by the company Mutual Pharm.
Indication
Lorazepam is FDA-approved for the short-term relief of anxiety symptoms related to anxiety disorders and anxiety associated with depressive symptoms such as anxiety-associated insomnia. It is as well used as an anesthesia premedication in adults to relieve anxiety or to produce sedation/amnesia and for the treatment of status epilepticus. Some off-label indications of lorazepam include rapid tranquilization of an agitated patient, alcohol withdrawal delirium, alcohol withdrawal syndrome, muscle spasms, insomnia, panic disorder, delirium, chemotherapy-associated anticipatory nausea and vomiting, and psychogenic catatonia.
Associated Conditions
- Agitation
- Alcohol Withdrawal Delirium
- Alcohol Withdrawal Syndrome
- Anxiety
- Anxiety Disorders
- Chemotherapy-Induced Nausea and Vomiting
- Delirium
- Insomnia
- Muscle Spasms
- Panic Disorder
- Psychogenic Catatonia
- Status Epilepticus
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/12 | Phase 3 | Not yet recruiting | |||
2025/02/28 | Phase 4 | Not yet recruiting | |||
2025/01/29 | Phase 4 | Not yet recruiting | |||
2024/12/30 | Phase 2 | Recruiting | Lone Baandrup | ||
2024/07/11 | Phase 2 | Not yet recruiting | |||
2024/04/17 | Phase 3 | Not yet recruiting | State University of New York - Upstate Medical University | ||
2023/10/23 | Phase 4 | Recruiting | |||
2023/08/22 | Phase 4 | Recruiting | |||
2022/12/22 | Phase 2 | Recruiting | |||
2022/10/31 | Phase 4 | Recruiting | Zhenghui YI |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Contract Pharmacy Services-PA | 67046-924 | ORAL | 0.5 mg in 1 1 | 9/14/2017 | |
| Bausch Health US LLC | 0187-0063 | ORAL | 0.5 mg in 1 1 | 1/13/2023 | |
| Preferred Pharmaceuticals Inc. | 68788-7355 | ORAL | 0.5 mg in 1 1 | 7/25/2023 | |
| REMEDYREPACK INC. | 70518-0275 | ORAL | 1 mg in 1 1 | 1/4/2024 | |
| Amneal Pharmaceuticals LLC | 65162-015 | ORAL | 0.5 mg in 1 1 | 12/30/2022 | |
| Medsource Pharmaceuticals | 45865-499 | ORAL | 0.5 mg in 1 1 | 7/20/2018 | |
| RedPharm Drug Inc. | 67296-0306 | ORAL | 1 mg in 1 1 | 5/20/2011 | |
| Contract Pharmacy Services-PA | 67046-982 | ORAL | 2 mg in 1 1 | 6/26/2008 | |
| Leading Pharma, LLC | 69315-905 | ORAL | 1 mg in 1 1 | 12/10/2023 | |
| Bryant Ranch Prepack | 71335-1467 | ORAL | 1 mg in 1 1 | 5/22/2023 |
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 |
|---|---|---|---|---|---|
| APO-LORAZEPAM TABLET 1 mg | SIN03452P | TABLET | 1 mg | 6/17/1989 | |
| APO-LORAZEPAM TABLET 0.5 mg | SIN03708P | TABLET | 0.5 mg | 10/6/1989 | |
| LORANS 1 TABLET 1 mg | SIN00967P | TABLET | 1 mg | 5/10/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Lorazepam Tablets | 大西洋制药厂有限公司 | 国药准字HJ20171289 | 化学药品 | 片剂 | 6/14/2023 |
| Lorazepam Tablets | atlantic laboratories corporation, ltd. | 国药准字HJ20171290 | 化学药品 | 片剂 | 6/14/2023 |
| Lorazepam Tablets | 国药准字H20031065 | 化学药品 | 片剂 | 5/6/2020 | |
| Lorazepam Tablets | 国药准字H20052311 | 化学药品 | 片剂 | 9/7/2020 | |
| Lorazepam Tablets | 国药准字H20060105 | 化学药品 | 片剂 | 12/16/2020 | |
| Lorazepam Tablets | 大西洋制药厂有限公司 | 国药准字HJ20171288 | 化学药品 | 片剂 | 6/14/2023 |
| Lorazepam Tablets | 国药准字HC20150011 | 化学药品 | 片剂 | 7/24/2023 | |
| Lorazepam Tablets | 国药准字HC20150010 | 化学药品 | 片剂 | 7/24/2023 |
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 |
|---|---|---|---|---|---|
| ATIVAN lorazepam 2.5mg tablet bottle | 237802 | Medicine | A | 7/30/2015 | |
| Tranqipam 2.5 - South Africa | 347657 | Medicine | A | 11/9/2020 | |
| LORAZE lorazepam 0.5 mg tablet blister pack | 304314 | Medicine | A | 7/22/2019 | |
| LORAZE lorazepam 2.5 mg tablet blister pack | 304316 | Medicine | A | 7/22/2019 | |
| LORAZEPAM VIATRIS lorazepam 1 mg tablet blister pack | 304312 | Medicine | A | 7/22/2019 | |
| ATIVAN Lorazepam 1mg tablet blister pack | 10387 | Medicine | A | 7/4/1991 | |
| LORAZEPAM SCP lorazepam 0.5 mg tablet blister pack | 304308 | Medicine | A | 7/22/2019 | |
| Tranqipam 1 - South Africa | 347656 | Medicine | A | 11/9/2020 | |
| LORAZEPAM-WGR lorazepam 2.5 mg tablet blister pack | 439655 | Medicine | A | 5/6/2024 | |
| APO-LORAZEPAM lorazepam 2.5 mg tablet blister pack | 304307 | Medicine | A | 7/22/2019 |