Industry News & Updates

Are sleeping pills safe?

By Marc Lewis

The U.S. Food and Drug Administration is now requiring that the prescription sleep medicines Lunesta and Ambien carry a box warning. This is the regulators strongest warning and follows reports of serious side effects and deaths connected to the sleep drugs.

“We recognize that millions of Americans suffer from insomnia and rely on these drugs to help them sleep better at night. 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,” said FDA Acting Commissioner Ned Sharpless, M.D. “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.”

Warning labels will now be required on eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist).

The FDA found 66 serious adverse events related to the medications, including:

  • 46 cases of serious injuries related to “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”
  • and 20 deaths related to “carbon monoxide poisoning, drowning, fatal falls, hypothermia, fatal motor vehicle collisions with the patient driving and apparent suicide”

The agency also issued new guidance to healthcare professional who are prescribing sleep aids and patients will now receive additional literature with their medicines.

Ambien has longed been blamed for the bad behavior of celebrities and politicians, and there is even a subreddit dedicated to the odd things one may do on the drug. The recent move against sleep medicines continues a trend wherein government agencies and consumers are evaluating the benefits of prescriptions against their risks. Just last year the FDA announced an action plan to combat the still growing opioid epidemic.

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