Australian drug regulator puts boxed warning on sleep aids containing zolpidem

Australia's medicines regulator, the Therapeutic Goods Administration, has imposed a boxed warning in the product information documents for medicines containing zolpidem, including French pharmaceutical major Sanofi-Aventis' original Stilnox brand, and has said that it is timely for pharmacists to reinforce "quality use of medicines" messages to ensure that patients use this insomnia drug appropriately.

This builds on other actions by the TGA to strengthen warnings about the potential side effects of zolpidem, following reports of bizarre and sometimes dangerous sleep-related behaviors such as sleep walking and driving in some users of the drug. These behaviors may have serious consequences for users of zolpidem, and it is important that health care professionals and the public are advised about these side effects, the agency said.

The US Food and Drug Administration called for label changes for all sleep disorder drugs - including zolpidem, last year, again on the basis of unusual/bizarre behavior (Marketletter March 26, 2007).