Medication Monitor

Generic Name (Trade Name—Company)
May 1, 2019

Multiple generic names

(Multiple trade names—Multiple manufacturers)
FDA issues new boxed warning on serious dangers of insomnia meds

FDA is warning 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 with other prescription medicines used for sleep.

If patients experience a complex sleep behavior during which they engage in activities while they are not fully awake, or do not remember activities they have done while taking the medicine, they should stop taking their insomnia medication and contact their health professional right away.

Health professionals should not prescribe eszopiclone, zaleplon, or zolpidem to patients who have previously experienced complex sleep behaviors after taking any of these medicines. Health professionals should advise all patients that although rare, the behaviors caused by these medicines have led to serious injuries or death, and they should discontinue taking these medicines if they experience an episode of complex sleep behavior.