Zaleplon

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

Indication

For the treatment of short-term treatment of insomnia in adults.

Associated Conditions

Insomnia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Zaleplon in HIV Patients With Depression	2018/04/05	NCT03489304	Phase 2	Completed	University of Pennsylvania
Cerebral MRI During Sleep	2017/10/09	NCT03304652	N/A	Completed	University of California, San Diego
Pharmacovigilance in Gerontopsychiatric Patients	2015/03/02	NCT02374567	Phase 3	Terminated	Hannover Medical School
A Polysomnographic Study to Compare the Efficacy of Gastric Retentive Zaleplon Accordion Pill to Placebo in Subjects With Insomnia	2011/01/14	NCT01277107	Phase 2	Completed	Intec Pharma Ltd.
Hypnotic Medications and Memory: Effect of Drug Exposure During the Night	2010/07/09	NCT01159652	Phase 4	Completed	St. Luke's Hospital, Chesterfield, Missouri
Zaleplon 10mg Capsules Under Fasting Conditions	2009/01/27	NCT00829998	Phase 1	Completed	Teva Pharmaceuticals USA
Zaleplon 10 mg Capsules Under Non-Fasting Conditions	2009/01/27	NCT00829868	Phase 1	Completed	Teva Pharmaceuticals USA
Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions	2008/06/10	NCT00694317	Not Applicable	Completed	Roxane Laboratories
Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions	2008/06/10	NCT00694187	Not Applicable	Completed	Roxane Laboratories

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
zaleplon	Aidarex Pharmaceuticals LLC	33261-454	ORAL	10 mg in 1 1	1/31/2014
zaleplon	Unichem Pharmaceuticals (USA), Inc.	29300-132	ORAL	10 mg in 1 1	6/28/2021
ZALEPLON	H.J. Harkins Company, Inc.	52959-957	ORAL	10 mg in 1 1	8/31/2011
Zaleplon	Bionpharma Inc.	69452-365	ORAL	10 mg in 1 1	2/13/2024
ZALEPLON	Rising Health, LLC	57237-240	ORAL	10 mg in 1 1	9/21/2019
ZALEPLON	Physicians Total Care, Inc.	54868-5909	ORAL	5 mg in 1 1	5/23/2012
ZALEPLON	Ascend Laboratories, LLC	67877-210	ORAL	5 mg in 1 1	12/1/2010
zaleplon	Preferred Pharmaceuticals Inc.	68788-7208	ORAL	10 mg in 1 1	10/24/2023
Zaleplon	Bryant Ranch Prepack	71335-1387	ORAL	10 mg in 1 1	1/13/2022
Zaleplon	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	常州华生制药有限公司	国药准字H20040520	化学药品	片剂	8/17/2020
Zaleplon Tablets	上海中华药业有限公司	国药准字H20050305	化学药品	片剂	7/8/2020
Zaleplon Tablets	蚌埠丰原涂山制药有限公司	国药准字H20031063	化学药品	片剂	6/23/2020
Zaleplon Tablets	广汇汽车服务集团股份公司	国药准字H20031297	化学药品	片剂	6/4/2020
Zaleplon Tablets	南京星银药业集团有限公司	国药准字H20070223	化学药品	片剂	8/22/2022
Zaleplon Tablets	蚌埠丰原涂山制药有限公司	国药准字H20030573	化学药品	片剂	6/19/2020
Zaleplon Tablets	山东良福制药有限公司	国药准字H20052170	化学药品	片剂	4/27/2020
Zaleplon Tablets	天津太平洋制药有限公司	国药准字H20052234	化学药品	片剂	8/29/2020
Zaleplon Dispersible Tablets	三门峡赛诺维制药有限公司	国药准字H20040035	化学药品	片剂	4/22/2020
Zaleplon Capsules	西南药业股份有限公司	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.

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