From the US Food and Drug Administration
The U.S. Food and Drug Administration today announced the agency is requiring a new boxed warning on certain prescription insomnia drugs.
The boxed warning follows several reports of rare, but serious injuries and deaths resulting from various complex sleep behaviors after taking these medicines. T
hese 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).
“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.
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.
In a Drug Safety Communication issued today, the FDA provides recommendations for health care professionals and patients and a summary of the data that led to these warnings.
Health care professionals should not prescribe eszopiclone, zaleplon, or zolpidem to patients who have a history of complex sleep behavior after taking these insomnia medicines. Patients should be advised that rare, but serious injuries and death are possible.
Patients should discontinue taking these medicines and contact their health care professional right away if they find themselves to have engaged in activities while not fully awake or if they do not remember activities done while taking the medicine.
Health care professionals and patients should report side effects from eszopiclone, zaleplon, zolpidem or other medicines to the FDA’s MedWatch program.