STORY FROM: Drugs & Medical Devices

FDA Adds Boxed Warnings to Ambien, Other Prescription Sleep Aids

WASHINGTON, D.C. — The Food and Drug Administration has ordered the makers of Ambien, Lunesta and other common prescription insomnia drugs to add a boxed warning regarding injuries caused by sleepwalking and sleep driving.

In an April 30 Safety Communication, the agency explained that “rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake.”

The FDA added that the complex sleep behaviours have also resulted in deaths. Such behaviors appear to be more common with prescription sleep aids Lunesta (eszopiclone), Sonata ...



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