Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Sonata has been withdrawn at the request of the marketing authorisation holder.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
Pharmacotherapeutic group
Psycholeptics
Therapeutic indication
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.