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FDA requires stronger warnings about rare but serious incidents related to certain prescription insomnia medicines

The U.S. Food and Drug Administration today announced the agency is requiring a new boxed warning – the agency’s most prominent warning – on certain prescription insomnia drugs to better ensure patients and their health care professionals have the information they need when considering use of these medicines. The boxed warning follows several reports of rare, but serious injuries and deaths resulting from various complex sleep behaviors after taking these medicines. These complex sleep behaviors may include sleepwalking, sleep driving and engaging in other activities while not fully awake, such as unsafely using a stove. The new warnings will be required for eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist).

“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. The association between these drugs and complex sleep behaviors is already included in the label, which has been updated continually to note additional safety issues as they were identified. The boxed warning and contraindication are intended to make the warning more prominent and reflect the risk of serious injury and death. Read complete article.

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