FDA Requests Label Change for All Sleep Disorder Drug Products

Jacob Diesselhorst

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The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks.

These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.

Press Release here:

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html: