Europe’s Coordination Group for Mutual Recognition and Decentralised Procedures–Human (CMDh) has endorsed by majority new recommendations for zolpidem-containing medicines, used for the treatment of insomnia. The CMDh agreed that the benefit-risk balance of these medicines remains positive; however, some changes will be made to the product information to minimize the known risk of reduced mental alertness and impaired ability to drive and use machinery the morning after use, the European Medicines Agency (EMA) says in a release.
These recommendations follow a review by the EMA’s Pharmacovigilance Risk Assessment Committee of available data on the safety of zolpidem with regard to the risk of impaired driving, somnambulism, and reduced mental alertness (such as drowsiness and slower reactions) after taking the medicine, and information on its effectiveness at lower doses.
Changes to be made to the product information of zolpidem-containing medicines include strengthened warnings and precautions. The normal recommended daily dose in adults, which must not be exceeded, will remain at 10 mg, and for older patients and patients with reduced liver function, it will remain at 5 mg. 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. Furthermore, patients should not drive or perform activities that require mental alertness for at least 8 hours after taking zolpidem. Since the risk of impaired driving seems to increase if zolpidem is taken together with other medicines that have an effect on the central nervous system (brain and spinal cord), or with alcohol or illicit drugs, these substances should not be used when taking zolpidem.
As the CMDh position on zolpidem was adopted by majority vote, it will now be sent to the European Commission, which will make a European Union-binding decision.