• The New York Times, Thursday, March 15, 2007 11:46 AM

The Food and Drug Administration yesterday ordered the makers of the well-known drugs Ambien and Lunesta and the producers of 11 other commonly used sleeping pills to put warnings about possible side effects on their packaging and to create patient fliers explaining how to use the medications safely.

The fliers, which the FDA says it requires when it sees a significant public-health concern, will be handed out at pharmacies when consumers fill their prescriptions.

Although the agency says that problems with the drugs are rare, reports of the unusual side effects have grown, as sleeping pill usage has increased. They range from fairly benign sleepwalking episodes to hallucinations, violent outbursts, nocturnal binge eating and--most troubling of all--driving while asleep.

Sales in the United States of Ambien and Lunesta alone last year exceeded $3 billion, and use of sleep aids has soared by more than 60% since 2000, fueled by television, print and other advertising.

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