Warnings Added to Common Sleep Pills


The Food and Drug Administration (FDA) is requiring a Boxed Warning, the most prominent warning, to be added to 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) in a class of medicines called sedative-hypnotics than other prescription medicines used for sleep. The FDA is also requiring a Contraindication, the strongest warning, to avoid use in patients who have previously experienced an episode of complex sleep behavior with eszopiclone, zaleplon, and zolpidem. Patients should stop taking your insomnia medicine and contact your health care professional right away if you experience a complex sleep behavior where you engage in activities while you are not fully awake or if you do not remember activities you have done while taking the medicine. All medicines taken for insomnia can impair driving and activities that require alertness the morning after use, even if you feel fully awake. Source: https://www.fda.gov/

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