Pharmacy Services Alerts
Eszopiclone (Lunesta), Zaleplon (Sonata), and Zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) May Cause Serious Injuries From Complex Sleep Behaviors – New Boxed Warning and Contraindication
May 3, 2019 11:52 AM
On April 30, 2019, the FDA warned that use of certain insomnia medications has caused complex sleep behaviors resulting in serious harm or death. These complex sleep behaviors include sleep driving, sleepwalking, and engaging in other activates while not fully awake. Complex sleep behaviors can result in serious injuries and death after just taking one dose of these medications, even at the lowest recommended dose. This safety alert is based on 66 case reports of complex sleep behaviors resulting in serious injuries or death over the past 26 years. Cases included burns, falls with serious injuries, drowning, fatal motor vehicle accidents, gunshot wounds, hypothermia, and suicide attempts. The mechanism of why these medications causes these behaviors are unknown, and most patients did not remember the event.
The FDA is requiring a new Boxed Warning for eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist). They are also requiring a contraindication to avoid using these products in patients who have a history of complex sleep behaviors after taking them. The FDA advises against prescribing eszopiclone, zaleplon, or zolpidem to patients who experienced complex sleep behaviors after taking these medications. Educate all patients about the risk of serious injuries from complex sleep behaviors. Patients who experience complex sleep behaviors while on these medications are advised to stop taking them and contact their health care professional as soon as possible. Prescribers and patients are urged to report side effects involving these insomnia medications through the FDA MedWatch Program: www.accessdata.fda.gov/scripts/medwatch/index.cfm
More information is available at the following links:
- FDA Safety Announcement