European Medicines Agency - News and Events - CMDh endorses
Changes to be made to the product information of The daily dose of zolpidem remains 10 mg a day in adults and 5 mg a day in the elderly.
Information to healthcare professionals.
Monika Benstetter or Martin Harvey. +44 (0)20 7418 8427 EMA.
Zolpidem is a medicine used for the short-term treatment of insomnia. It acts by attaching to and stimulating a particular type of receptor on nerve cells called the alpha-1 GABA-A receptor (also called the omega-1 receptor). This receptor is part of a system in the brain that normally responds to a neurotransmitter called gamma-aminobutyric acid (GABA) and which reduces the activity of the brain, causing relaxation and sleepiness. A neurotransmitter is a chemical that carries signals between nerve cells. By stimulating the receptor, zolpidem is able to enhance this effect, helping patients to sleep.
The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has endorsed by majority new recommendations for zolpidem-containing medicines, used for the short-term treatment of insomnia (difficulty sleeping). The CMDh agreed that the benefit-risk balance of these medicines remains positive; however, some changes will be made to the product information to minimise the known risk of reduced mental alertness and impaired ability to drive and use machinery the morning after use.
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.
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These recommendations are based on a careful assessment of the available data on the safety and efficacy of zolpidem from clinical studies, post-marketing reports and the published literature.
Zolpidem has been authorised via national procedures in all Member States of the EU.
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As the CMDh position on zolpidem was adopted by majority vote, it will now be sent to the European Commission, which will take an EU-wide legally binding decision. Information to patients.
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A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC). As zolpidem-containing medicines are all authorised nationally, the PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which adopted a final position. The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
These recommendations follow a review by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) of available data on the safety of zolpidem with regards 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.
As the CMDh position was adopted by majority vote, it will now be sent to the European Commission, which will take an EU-wide legally binding decision.
The review of zolpidem-containing medicines was initiated on 4 July 2013 at the request of the Italian Medicines Agency (AIFA) under Article 31 of Directive 2001/83/EC.