The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) reviewed the available data on the safety of zolpidem with regards to the risk of impaired driving, somnambulism, and reduced mental alertness after taking the medicine and information on its effectiveness at lower doses, and released its recommendations in March 2014. The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has now endorsed these recommendations, which will be passed onto the European Commission for an EU-wide legally binding decision.
The recommendations include the following:
• Some changes will be made to the product information for zolpidem-containing medicines, including strengthened warnings and precautions.
• The normal recommended daily doses will remain the same (10mg for adults and 5mg for older patients and patients with reduced liver function). Patients should take the lowest effective dose of zolpidem in a single intake just before going to bed and should not take another dose during the same night.
• Patients should not drive or perform activities that require mental alertness for at least 8 hours after taking zolpidem.
• As the risk of impaired driving seems to increase if zolpidem is taken together with other medicines that have an effect on the CNS, or with alcohol or illicit drugs, these substances should not be used when taking zolpidem.