FDA Warns Public of Sleepwalking Injuries from Insomnia Drugs

FDA Warns Public of Sleepwalking Injuries from Insomnia Drugs

The FDA recently advised that rare but serious injuries, including death, 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 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.

As a result, the FDA now requires a Boxed Warning to be added to the prescribing information and the patient medication guides for these medicines. Furthermore, the FDA will require a contraindication, their strongest warning, to avoid using these drugs in patients who have previously experienced an episode of complex sleep behavior with eszopiclone, zaleplon, and zolpidem.

Serious injuries and death from complex sleep behaviors have occurred in patients with and without a history of such behaviors, even at the lowest recommended doses, and the behaviors can occur after just one dose, and without our without alcohol or other central nervous system depressants that may be sedating such as tranquilizers, opioids, and anti-anxiety medicines.

For more information, read the FDA’s Safety Announcement.