MedPath

Zaleplon

Generic Name
Zaleplon
Brand Names
Sonata
Drug Type
Small Molecule
Chemical Formula
C17H15N5O
CAS Number
151319-34-5
Unique Ingredient Identifier
S62U433RMH

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

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.
© Copyright 2025. All Rights Reserved by MedPath