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  5. Certain Prescription Insomnia Medicines: New Boxed Warning - Due to Risk of Serious Injuries Caused by Sleepwalking, Sleep Driving and Engaging in Other Activities While Not Fully Awake
  1. Medical Product Safety Information

Certain Prescription Insomnia Medicines: New Boxed Warning - Due to Risk of Serious Injuries Caused by Sleepwalking, Sleep Driving and Engaging in Other Activities While Not Fully Awake

[Posted 04/30/2019]

AUDIENCE: Patient, Health Professional, Pharmacy

ISSUE: 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

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

than other prescription medicines used for sleep.

BACKGROUND: Eszopiclone, zaleplon, and zolpidem are medicines used to treat insomnia in adults who have difficulty falling asleep or staying asleep. They are in a class of medicines called sedative-hypnotics and have been approved and on the market for many years. These insomnia medicines work by slowing activity in the brain to allow sleep. Quality sleep can have a positive impact on physical and mental health.

RECOMMENDATION: 

If patients experience a complex sleep behavior where you engage in activities while you are not fully awake or if you do not remember activities you have done while taking the medicine you should:

  • Stop taking your insomnia medicine.
  • Contact your health care professional right away if you.

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:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report 
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178

[04/30/2019 - Drug Safety Communication - FDA] 

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