FDA adds boxed warning for Ambien, other prescription insomnia medications

The Food and Drug Administration 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 Lunesta, Sonata, Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist than other prescription medicines used for sleep. The FDA said: “As a result, we are requiring a Boxed Warning, our most prominent warning, to be added to the prescribing information and the patient Medication Guides for these medicines. We are also requiring a Contraindication, our strongest warning, to avoid use in patients who have previously experienced an episode of complex sleep behavior with eszopiclone, zaleplon, and zolpidem.” “We identified 66 cases of complex sleep behaviors occurring with these medicines over the past 26 years that resulted in serious injuries, including death,” the FDA said. The Fly notes that Ambien is marketed by Sanofi (SNY), while Sonata is marketed by Pfizer (PFE).

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