Is Zaleplon approved by the US FDA?

Drugs@FDA lists 11 application product lines for Zaleplon, including ZALEPLON (Prescription); ZALEPLON (Prescription); ZALEPLON (Prescription); ZALEPLON (Prescription); ZALEPLON (Prescription).

Is Zaleplon authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Zaleplon.

Are there safety signals or safety updates for Zaleplon?

US FDA: 1 entry (latest 2019-08-18).

Active substance

Zaleplon

US FDA 11
EMA 2
US price lines 2
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ZALEPLON	5MG; 10MG	capsule · oral	HIKMA PHARMS	Prescription	6 Jun 2008
ZALEPLON	5MG; 10MG	capsule · oral	AUROBINDO PHARMA	Prescription	6 Jun 2008
ZALEPLON	5MG; 10MG	capsule · oral	UNICHEM	Prescription	6 Jun 2008
ZALEPLON	5MG; 10MG	capsule · oral	CHARTWELL MOLECULAR	Prescription	20 Jun 2008
ZALEPLON	5MG; 10MG	capsule · oral	ORBION PHARMS	Prescription	17 Sep 2009
SONATA	5MG; 10MG	capsule · oral	PFIZER	Discontinued	13 Aug 1999
ZALEPLON	5MG; 10MG	capsule · oral	NATCO PHARMA	Discontinued	6 Jun 2008
ZALEPLON	5MG; 10MG	capsule · oral	TEVA PHARMS	Discontinued	6 Jun 2008
ZALEPLON	5MG; 10MG	capsule · oral	UPSHER SMITH LABS	Discontinued	6 Jun 2008
ZALEPLON	5MG; 10MG	capsule · oral	UPSHER SMITH LABS	Discontinued	6 Jun 2008
ZALEPLON	5MG; 10MG	capsule · oral	HIKMA PHARMS	Discontinued	25 Nov 2008

EMA European Union — centrally authorised medicines

Sonata Meda AB · Withdrawn · authorised 12 Mar 1999 · ATC N05CF03

Therapeutic indication (EMA)

Sonata is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.

Zerene Meda AB · Withdrawn · authorised 12 Mar 1999 · ATC N05CF03

Therapeutic indication (EMA)

Zerene is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ZALEPLON 10 MG CAPSULE	$0.1409	per EA	23 Sep 2026
US NADAC	ZALEPLON 5 MG CAPSULE	$0.15681	per EA	23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 18 Aug 2019 SONATA — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for zaleplon →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.