Common insomnia drugs now have boxed warning for serious injuries, death

FDA has added a boxed warning, its most prominent warning, to the prescribing information and the patient Medication Guides of common prescription insomnia medications, including eszopiclone (Lunesta—Sunovion Pharmaceuticals), zaleplon (Sonata—Pfizer), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist). In a drug safety communication, the agency cautioned that rare but serious injuries and even death have occurred as a result of people taking these drugs and then engaging in complex sleep behaviors while not fully awake, including sleepwalking, sleep driving, and other activities.

FDA is also requiring a contraindication, its strongest warning, for use in patients who have previously experienced an episode of complex sleep behavior with eszopiclone, zaleplon, or zolpidem. Health professionals should not prescribe these drugs to patients who have previously experienced complex sleep behaviors after taking any of these medications.

The agency has identified 66 cases of complex sleep behaviors occurring with these medications over the past 26 years that resulted in serious injuries, including death. These cases included accidental overdoses, falls, burns, near drowning, exposure to extreme cold temperatures leading to loss of limb, carbon monoxide poisoning, drowning, hypothermia, motor vehicle collisions with the patient driving, and self-injuries such as gunshot wounds and apparent suicide attempts. Patients usually did not remember these events.

FDA noted that there may be additional cases, as this number only includes reports submitted to FDA or those found in the medical literature.

FDA said it is continuing to monitor the safety of insomnia medications and will update the public as new information becomes available. The agency urges health professionals and patients to report adverse effects involving eszopiclone, zaleplon, and zolpidem or other insomnia drugs to the FDA MedWatch program at

For the full article, please visit for the July 2019 issue of Pharmacy Today.