U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Drug Safety and Availability
  4. FDA Drug Safety Podcasts
  5. FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines
  1. Drug Safety and Availability

FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines

FDA Drug Safety Podcast

Listen

Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin Advanced Practice Nurse.

On April 30, 2019, FDA advised 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 (brand name Lunesta), zaleplon (brand name Sonata), and zolpidem (brand names Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) than other prescription medicines used for sleep.

As a result, we are requiring a Boxed Warning, our most prominent warning, be added to the prescribing information and the patient Medication Guides for these medicines. We are also requiring a Contraindication, our strongest warning, to avoid use in patients who have previously experienced an episode of complex sleep behavior with eszopiclone, zaleplon or zolpidem.

These medicines are used to treat insomnia in adults who have difficulty falling asleep or staying asleep. 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.

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. We 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.

We communicated safety information associated with certain insomnia medicines in January and May 2013 and May 2014. We continue to monitor the safety of these medicines and will update the public as new information becomes available.

To help FDA track safety issues with medicines, we urge health care professionals and patients to report side effects involving these or other medicines to the FDA MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/drugsafetycommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

And follow us on Twitter @FDA_Drug_Info. Thank you for listening.

Related Information