FDA adds boxed warnings to insomnia medicines following injuries, deaths
The FDA on Tuesday announced the addition of a boxed warning to certain prescription insomnia medicines because of various behaviors, including sleepwalking and sleep driving, that have led to injuries and deaths.
The agency said the 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.”
Over the past 26 years, the 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. The 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.”
Serious injuries cited by the FDA include falls, burns, near drowning, exposure to extreme cold temperatures leading to loss of limb, carbon monoxide poisoning, drowning and hypothermia.
“Most of these patients reported using zolpidem (n=61) when they experienced a complex sleep behavior. The remaining patients took eszopiclone (n=3) or zaleplon (n=2). These data are consistent with the higher number of zolpidem prescriptions dispensed compared to eszopiclone and zaleplon,” the FDA said.
In its safety communication, the FDA also reminds the public that all medicines taken for insomnia can impair driving and activities that require alertness the morning after use.
“Drowsiness is already listed as a common side effect in the drug labels of all insomnia medicines, along with warnings that patients may still feel drowsy the day after taking these products. Patients who take insomnia medicines can experience decreased mental alertness the morning after use even if they feel fully awake,” FDA said.
First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.
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