Sonata

RSS

zaleplon

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Sonata has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 21/10/2015

Authorisation details

Product details
Name
Sonata
Agency product number
EMEA/H/C/000227
Active substance
zaleplon
International non-proprietary name (INN) or common name
zaleplon
Therapeutic area (MeSH)
Sleep Initiation and Maintenance Disorders
Anatomical therapeutic chemical (ATC) code
N05CF03
Publication details
Marketing-authorisation holder
Meda AB
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
12/03/1999
Contact address
Pipers väg 2A
170 09 Solna
Sweden

Product information

03/07/2015 Sonata - EMEA/H/C/000227 - PSUSA/00003140/201407

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Psycholeptics

Therapeutic indication

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.

Assessment history

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