LOUISVILLE, Ky. (WDRB) -- The U.S. Food and Drug Administration (FDA) is requiring new boxed warnings on certain prescription insomnia drugs, according to a news release.
The drugs include eszopiclon, zaleplon and zolpidem. These are drugs found in popular sleep aids, including Lunesta, Sonata, Ambien, Ambien CR, Edluar, Intermezzo and Zolpimist.
The new warnings are the agency's most prominent warnings, and are being implemented as a result of, "rare, but serious injuries and deaths resulting from various complex sleep behaviors" experienced by some people who took the medicines.
Specifically, the news release cites 66 cases in which patients "engaged in activities while they were not fully awake, such as sleepwalking or driving, that resulted in serious injuries or death."
"The 46 reports of non-fatal serious injuries included accidental overdoses, falls, burns, near-drowning, exposure to extreme cold temperatures leading to loss of limb or near death, self-injuries such as gunshot wounds and apparent suicide attempts," he news release states. "The 20 deaths reported were from carbon monoxide poisoning, drowning, fatal falls, hypothermia, fatal motor vehicle collisions with the patient driving and apparent suicide."
"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 Ned Sharpless, M.D., according to a statement. "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."
"Today's action is an important step in our ongoing effort to call more attention to these critical safety issues and serves as an example of our ongoing commitment to ensuring that patients and health care professionals have the information they need to make informed treatment decisions."
For more information on the warnings, CLICK HERE.
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