FDA has slapped a number of prescription insomnia drugs with a new boxed warning, known to be the agency's most prominent warning.
The new warning will be required from specific medication, including eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist).
In the official announcement, FDA revealed that the move is a response to several cases of serious injuries and deaths resulting from varying complex sleep behaviors that occurred after taking the pills. The behaviors range from sleepwalking to sleep driving and other potentially dangerous activities.
FDA Issues 'Black Box' Warning For Insomnia Drugs
"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," said FDA acting commissioner Ned Sharpless, M.D., adding that serious incidents are rare, but it is extremely important for both physicians and patients to be aware of the various risks that can occur while taking these medications.
Along with the warning, FDA also requires the contraindication that tells patients to stop using an insomnia drug after having one episode of complex sleep behavior after taking it.
Janet Woodcock, who is the director of the agency's Center for Drug Evaluation and Research, explained that officials have been watching and monitoring the safety profile of these prescription drugs since their approval.
"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," Woodcock said, adding that the team is planning to continue with their monitoring and evaluation moving forward to make changes should it become necessary.
While these medications already include a label about their associations to complex sleep behaviors, the new boxed warning and contraindication are meant to make the warning more prominent and communicate the potentially serious and deadly risks.
Severe Risks Of Taking Insomnia Drugs
FDA has identified 66 cases of patients in the past 26 years who took these insomnia drugs, then went on to experience serious injuries or death without being fully awake, according to a report from CNN.
There have been 46 cases of non-fatal injuries, ranging in severity. Some of the incidents recorded are accidental overdoses, burns, near-drowning, falls, loss of limb from extreme temperature exposure, gunshot wounds, and even suicide attempts.
A total of 20 deaths have occurred for a variety of reasons, including carbon monoxide poisoning, drowning, falls, hypothermia, car crashes, and suicide.
In 2012, a paper published in the Primary Care Companion for CNS Disorders detailed two cases of people killing their spouses under the influence of zolpidem. In both incidents, the individuals involved had no record of previous aggressive behavior.