FDA says certain prescription medicines for insomnia must carry box warnings

“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 Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in the announcement. “We’ll continue to monitor and evaluate these risks associated with insomnia medications and communicate with the public or consider further actions, as appropriate.”

FDA said some of the side effects of taking the medications have included sleepwalking, sleep driving and engaging in other activities while not fully awake, such as unsafely using a stove. The agency is also ordering companies to add a contraindication to not use these medicines in patients who have experienced an episode of complex sleep behaviors after taking them.

The agency noted 46 reports of non-fatal serious injuries including accidental overdoses, falls, burns, near-drowning, exposure to extreme cold temperatures with loss of limb or near death, self-injuries such as gunshot wounds and apparent suicide attempts. The 20 deaths reported were from carbon monoxide poisoning, drowning, fatal falls, hypothermia, fatal motor vehicle collisions with the patient driving and apparent suicide.

“While these incidents are rare, they are serious and it’s important that patients and health care professionals are aware of the risk,” said FDA Acting Commissioner Ned Sharpless in the announcement. 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.”