USA – FDA Adds Boxed Warnings to Insomnia Medicines Following Injuries, Deaths

The US Food and Drug Administration (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, 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. 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.”…