New Boxed Warning on Certain Prescription Insomnia Medicines

PUBLISHED: Apr 30, 2019
Relevant to: All Healthcare Organizations

The US Food and Drug Administration (FDA) is advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths. These behaviors appear to be more common with the following three medications than with other prescription medicines used for sleep.

  • Lunesta (eszopiclone)
  • Sonata (zaleplon)
  • Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist (zolpidem)

The FDA is advising that if patients experience a complex sleep behavior where they are engaging in activities while not fully awake or if they do not remember activities done while taking the medicine, they should stop taking insomnia medicine and contact their health care professional right away.

Healthcare professionals should not prescribe eszopiclone, zaleplon, or zolpidem to patients who have previously experienced complex sleep behaviors after taking any of these medicines. Healthcare Professionals should advise all patients that:

  • Although rare, the behaviors caused by these medicines have led to serious injuries or death.
  • To discontinue taking these medicines if they experience an episode of complex sleep behavior.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

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