EU Body OKs Zolpidem Label Changes to Avoid Drowsy Driving

April 25, 2014

A European Union (EU) group representing drug regulators from member states has endorsed recommendations to reduce the risk for drowsy driving by patients taking zolpidem (Ambien, sanofi-aventis) for insomnia, the European Medicines Agency (EMA) announced today.

One recommendation is that patients taking zolpidem at bedtime should not take a second dose later that night. In addition, the patient should not drive or perform activities requiring an alert mind until 8 hours after taking the drug.

The EU group in question, the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh), okayed a set of label changes for zolpidem proposed last month by the Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA. CMDh agreed with PRAC that although zolpidem should remain on the market, something must be done to address the problem of next-morning impaired driving, which encompasses slower reactions as well as drowsiness.

Under the label changes recommended by PRAC and endorsed by CMDh, the daily dose of zolpidem remains 10 mg for adults and 5 mg for the elderly and patients with hepatic impairment. "This dose must not be exceeded," said the EMA. These are the same doses approved by the US Food and Drug Administration for zolpidem, except that the recommended initial daily dose for women is 5 mg. In addition, patients should take the lowest dose that proves effective in a single intake at bedtime, and alcohol, illicit drugs, and legal drugs that affect the central nervous system should not be taken together with zolpidem, as they appear to increase the risk for impaired driving.

The recommendations now go to the European Commission, the EU's executive body, for a final decision that will be binding on all EU members.


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