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.

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
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
02297124
Capsule - Oral
5 MG
N/A
STARNOC
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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