Eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) are some prescription medicines which are used to treat insomnia in adults who have difficulty falling asleep or staying asleep.
FDA advised that with these medicines there were serious injuries including sleepwalking, sleep driving, and engaging in other activities while not fully awake and death from complex sleep behaviors have occurred in patients with and without a history of such behaviors, even at the lowest recommended doses.
Health care professionals should not prescribe eszopiclone, zaleplon, or zolpidem to patients who have previously experienced complex sleep behaviors after taking any of these medicines.
Advise all patients that although rare, the behaviors caused by these medicines have led to serious injuries or death.
FDA identified 66 cases of complex sleep behaviors occurring with these medicines over the past 26 years that resulted in serious injuries, including death. This number includes only reports submitted to FDA or found in the medical literature, so there may be additional cases about which we are unaware.
The underlying mechanisms by which these medicines cause complex sleep behaviors are not completely understood.
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