Sleep Meds Now Require Prominent Death, Injury Warning: FDA

The Food and Drug Administration has for years warned about possible side effects of taking sleeping pills and this week, federal health officials issued their strongest warning yet.

On Tuesday, the FDA announced it had ordered drugmakers of popular prescription insomnia medications to add "black box" warning labels — the agency’s most prominent warning — to caution patients about their dangers after an investigation found cases of serious injuries, and even death, resulting from various "complex behaviors" tied to the drugs. Those behaviors included sleepwalking, sleep driving, and "engaging in other activities while not fully awake, such as unsafely using a stove," the FDA said. 

Not all sleep aids pose these risks, the FDA noted.

The new warnings will be required for eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist). While the labels for these medicines already include a warning, the FDA said the new prominent "black box" warning is meant to emphasize the seriousness of the risk of injury or death when using these products. 

"We recognize that millions of Americans suffer from insomnia and rely on these drugs to help them sleep better at night," said FDA Acting Commissioner Dr. Ned Sharpless, in a press release. "While these incidents are rare, they are serious and it’s important that patients and health care professionals are aware of the risk. These incidents can occur after the first dose of these sleep medicines or after a longer period of treatment, and can occur in patients without any history of these behaviors and even at the lowest recommended doses.” 

The FDA investigated 66 cases reported to health officials and found in medical literature in which patients engaged in activities, such as sleepwalking or driving, that resulted in serious injuries or death after taking either eszopiclone, zaleplon or zolpidem. 

In 46 of the cases reviewed by the agency, the patients suffered non-fatal serious injuries, including "accidental overdoses, falls, burns, near-drowning, gunshot wounds and apparent suicide attempts. The 20 fatalities reported were from drowning, fatal falls, carbon monoxide poisoning, apparent suicide and fatal motor vehicle collisions with the patient driving.  

The FDA said it was now also requiring a contraindication advising people who have already experienced a complex sleep behavior to stop using these medicines.

"We have closely watched the safety profile of these drugs since they were approved. When our ongoing safety monitoring recently reflected the risk of more serious injuries and deaths from patients on these medications who experienced complex sleep behaviors, we determined there was a need to take stronger steps to inform the public,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. "We’ll continue to monitor and evaluate these risks associated with insomnia medications and communicate with the public or consider further actions, as appropriate."

According to the FDA, an estimated 30 million prescriptions of the three drugs were filled in the U.S. in 2018.  

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