Press Release: PRAC recommends product information of zolpidem be updated with new advice to minimise the risk of next-morning impaired driving ability and mental alertness

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) completed in March 2014 a review of zolpidem-containing medicines, used for the short-term treatment of insomnia (inability to sleep). The benefit-risk balance of these medicines remains positive, but the PRAC recommended changes to the product information, which are aimed at further minimising the known risks of next-morning impaired driving ability and mental alertness (including somnambulism).

• Primary Source

ESO: Background information: Press Release: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 March 2014 http://www.europeansources.info/record/press-release-meeting-highlights-from-the-pharmacovigilance-risk-assessment-committee-prac-3-6-march-2014/

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