Overview
Zaleplon is a sedative/hypnotic, mainly used for insomnia. It is known as a nonbenzodiazepine hypnotic. Zaleplon interacts with the GABA receptor complex and shares some of the pharmacological properties of the benzodiazepines. Zaleplon is a schedule IV drug in the United States.
Background
Zaleplon is a sedative/hypnotic, mainly used for insomnia. It is known as a nonbenzodiazepine hypnotic. Zaleplon interacts with the GABA receptor complex and shares some of the pharmacological properties of the benzodiazepines. Zaleplon is a schedule IV drug in the United States.
Indication
For the treatment of short-term treatment of insomnia in adults.
Associated Conditions
- Insomnia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2018/04/05 | Phase 2 | Completed | |||
2017/10/09 | N/A | Completed | |||
2015/03/02 | Phase 3 | Terminated | |||
2011/01/14 | Phase 2 | Completed | |||
2010/07/09 | Phase 4 | Completed | St. Luke's Hospital, Chesterfield, Missouri | ||
2009/01/27 | Phase 1 | Completed | |||
2009/01/27 | Phase 1 | Completed | |||
2008/06/10 | Not Applicable | Completed | |||
2008/06/10 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Aidarex Pharmaceuticals LLC | 33261-454 | ORAL | 10 mg in 1 1 | 1/31/2014 | |
Unichem Pharmaceuticals (USA), Inc. | 29300-132 | ORAL | 10 mg in 1 1 | 6/28/2021 | |
H.J. Harkins Company, Inc. | 52959-957 | ORAL | 10 mg in 1 1 | 8/31/2011 | |
Bionpharma Inc. | 69452-365 | ORAL | 10 mg in 1 1 | 2/13/2024 | |
Rising Health, LLC | 57237-240 | ORAL | 10 mg in 1 1 | 9/21/2019 | |
Physicians Total Care, Inc. | 54868-5909 | ORAL | 5 mg in 1 1 | 5/23/2012 | |
Ascend Laboratories, LLC | 67877-210 | ORAL | 5 mg in 1 1 | 12/1/2010 | |
Preferred Pharmaceuticals Inc. | 68788-7208 | ORAL | 10 mg in 1 1 | 10/24/2023 | |
Bryant Ranch Prepack | 71335-1387 | ORAL | 10 mg in 1 1 | 1/13/2022 | |
Hikma Pharmaceuticals USA Inc. | 0054-0085 | ORAL | 10 mg in 1 1 | 3/12/2019 |
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 |
---|---|---|---|---|---|
Zaleplon Tablets | 国药准字H20040520 | 化学药品 | 片剂 | 8/17/2020 | |
Zaleplon Tablets | 国药准字H20050305 | 化学药品 | 片剂 | 7/8/2020 | |
Zaleplon Tablets | 国药准字H20031063 | 化学药品 | 片剂 | 6/23/2020 | |
Zaleplon Tablets | 国药准字H20031297 | 化学药品 | 片剂 | 6/4/2020 | |
Zaleplon Tablets | 国药准字H20070223 | 化学药品 | 片剂 | 8/22/2022 | |
Zaleplon Tablets | 国药准字H20030573 | 化学药品 | 片剂 | 6/19/2020 | |
Zaleplon Tablets | 国药准字H20052170 | 化学药品 | 片剂 | 4/27/2020 | |
Zaleplon Tablets | 国药准字H20052234 | 化学药品 | 片剂 | 8/29/2020 | |
Zaleplon Dispersible Tablets | 国药准字H20040035 | 化学药品 | 片剂 | 4/22/2020 | |
Zaleplon Capsules | 国药准字H20030140 | 化学药品 | 胶囊剂 | 8/24/2020 |
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. |