- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Sonata has been withdrawn at the request of the marketing authorisation holder.
Product information
Latest procedure affecting product information:
PSUSA/00003140/201407
03/07/2015
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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).
Product details
- Name of medicine
- Sonata
- 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
Pharmacotherapeutic group
PsycholepticsTherapeutic 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.
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