FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines

The Food and Drug Administration (FDA) is advising 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. These complex sleep behaviors have also resulted in deaths.

These behaviors appear to be more common with eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) than other prescription medicines used for sleep.

As a result, the agency requiring a Boxed Warning, FDA’s most prominent warning, to be added to the prescribing information and the patient Medication Guides for these medicines. The agency also requiring a Contraindication, FDA’s strongest warning, to avoid use in patients who have previously experienced an episode of complex sleep behavior with eszopiclone, zaleplon, and zolpidem.

Over the past 26 years, FDA said it identified 66 cases (from the literature and reports submitted to FDA) of complex sleep behaviors occurring with these medicines that resulted in serious injuries and 20 deaths. FDA noted that patients usually did not remember experiencing such sleep behaviors and the “underlying mechanisms by which these insomnia medicines cause complex sleep behaviors are not completely understood.”

In its safety communication, FDA also reminds the public that all medicines taken for insomnia can impair driving and activities that require alertness the morning after use.

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