Insomnia Drugs Get Boxed Warning for Complex Sleep Behaviors

By Kelly Young

Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM

The FDA is requiring several prescription insomnia drugs to carry a boxed warning about the rare risks for sleepwalking, sleepdriving, and other unusual behaviors (e.g., using a stove while sleeping). The affected drugs include eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist).

These drugs are also now contraindicated in patients who have previously experienced complex sleep behaviors while taking them.

The FDA reviewed 20 reported deaths related to these drugs; causes included carbon monoxide poisoning, drowning, falls, hypothermia, car accidents with the patient driving, and apparent suicide. Additionally, the agency reviewed 46 reports of nonfatal injuries, including near-drowning, burns, falls, gunshot wounds, and apparent suicide attempts. Such behaviors were observed even when patients were taking the drugs for the first time and at the lowest doses.

Adverse events should be reported to the FDA's MedWatch program.