After a review, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the benefit-risk balance with zolpidem-containing medications remains positive, but it is recommending changes to the product information aimed at reducing the known risks of next-morning impaired driving ability and mental alertness, including somnambulism.
Zolpidem products are used for short-term treatment of insomnia. "The review of zolpidem was initiated after reports of impaired driving or road accidents the morning after patients took the medication," a statement from EMA released today notes.
Fonts: Medscape
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