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.

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 Fasting Conditions	2008/06/10	NCT00694187	Not Applicable	Completed	Roxane Laboratories
Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions	2008/06/10	NCT00694317	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
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
STARNOC	servier canada inc	02242220	Capsule - Oral	10 MG	6/27/2000
STARNOC	Pfizer Canada Ulc	02297124	Capsule - Oral	5 MG	N/A
STARNOC	Pfizer Canada Ulc	02297132	Capsule - Oral	10 MG	N/A

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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