Sonata

Withdrawn

This medicine's authorisation has been withdrawn

zaleplon

Overview

On 3 July 2015, the European Commission withdrew the marketing authorisation for Sonata (zaleplon) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Meda AB, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Sonata was granted marketing authorisation in the EU on 12 March 1999 for treatment of insomnia. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2004. 

The European Public Assessment Report (EPAR) for Sonata is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Sonata : EPAR - Summary for the public

Product information

Sonata : EPAR - Product Information

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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000227
• Marketing authorisation holder:
  Meda AB

  Pipers väg 2A; 170 09 Solna; Sweden

• Marketing authorisation issued:
  12/03/1999
• Withdrawal of marketing authorisation:
  03/07/2015
• Revision:
  19

Assessment history

Changes since initial authorisation of medicine

Sonata : EPAR - Procedural steps taken and scientific information after authorisation

Sonata-H-C-PSUSA-00003140-201407 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/268475/2015

Sonata : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Sonata : EPAR - Procedural steps taken before authorisation

Sonata : EPAR - Scientific Discussion