Tuesday, April 30, 2019

FDA Requires Stronger Warnings for Common Insomnia Medications

On Tuesday, the Food and Drug Administration (FDA) announced that several prescription sleep aids must now include a boxed warning—the FDA’s strongest safety warning—following reports of sleepwalking and other rare sleep behaviors that have led to serious injuries and deaths.

Sleep aids containing eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist) must carry the boxed warning as well as another warning against the use of the medications by patients with a history of sleepwalking or other rare sleep behaviors like sleep driving.

This is not the first time that the FDA has issued a safety alert regarding these medications. In 2013 and 2014, the FDA warned of next-morning impairment associated with zolpidem and eszopiclone.

"We have closely watched the safety profile of these drugs since they were approved," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "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."

The FDA reviewed 66 reports of serious injuries and deaths that occurred while patients were sleepwalking, sleep driving, or engaging in other activities (such as using a stove) while not fully awake, and most had no memory of the incident. The 46 nonfatal injuries reported included falls, burns, near-drownings, and apparent suicide attempts; causes of death included carbon monoxide poisoning, motor vehicle collisions, and apparent suicide.

"While these incidents are rare, they are serious and ... 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," said FDA Acting Commissioner Ned Sharpless, M.D.

For related information, see the Psychiatric News article “Self-Reports of Poor Sleep Not Always Accurate.”

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