Drug Safety Alerts

Insomnia Medicines Black Box Warning

04/30/2019

On April 30, 2019, the United States Food and Drug Administration (FDA) issued a MedWatch 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, the FDA is requiring a Boxed Warning, their most prominent warning, to be added to the prescribing information and the patient Medication Guides for these medicines. The FDA is also requiring a Contraindication, their 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.

The FDA recommends that 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. Healthcare Professionals should advise all patients that:

• Although rare, the behaviors caused by these medicines have led to serious injuries or death.

• To discontinue taking these medicines if they experience an episode of complex sleep behavior.

CVS Caremark Response:

Please note: There have been no recalls issued on these medicines because of this action, CVS Caremark Mail Service Pharmacy will continue to dispense these products.

For more information about this issue, health care providers may contact the FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.