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FDA Requires Boxed Warning for Insomnia Meds

May 2, 2019


The FDA now requires a new boxed warning for eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zaolpimist).

The boxed warning follows several reports of rare but serious injuries and deaths resulting from various complex sleep behaviors, such as sleepwalking, sleep driving, and engaging in other activities while not fully awake, such as unsafely using a stove.

“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.”

In addition to the boxed warning, the agency is requiring the addition of a contraindication to not use these medicines in patients who have experienced an episode of complex sleep behaviors after taking them.

Read the news release.

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