New Drug Safety Communication on certain prescription insomnia medicines – Drug Information Update

The Food and Drug Administration (FDA) is advising 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 other prescription medicines used for sleep.

As a result, we are requiring a Boxed Warning, our most prominent warning, to 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, 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. These behaviors can occur after taking these medicines with or without alcohol or other central nervous system depressants that may be sedating such as tranquilizers, opioids, and anti-anxiety medicines.

Eszopiclone, zaleplon, and zolpidem are medicines used to treat insomnia in adults who have difficulty falling asleep or staying asleep. They are in a class of medicines called sedative-hypnotics and have been approved and on the market for many years. These insomnia medicines work by slowing activity in the brain to allow sleep. Quality sleep can have a positive impact on physical and mental health.

Healthcare 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. Tell the patient to discontinue taking these medicines if they experience an episode of complex sleep behavior.

Patients should stop taking your insomnia medicine and contact your health care professional right away if you experience a complex sleep behavior where you engage in activities while you are not fully awake or if you do not remember activities you have done while taking the medicine.

For more information, please visit: Insomnia medicines