Tuesday, 18 Feb 2020

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FDA Adds Boxed Warning to Sleep Drugs

The Food and Drug Administration (FDA) added a Boxed Warning to several sleep medications (e.g., eszopiclone, zaleplon, and zolpidem), warning rare but serious injuries may occur as a result of abnormal sleep behaviors (sleepwalking, sleep driving, and engaging in other activities while not fully awake) when taking sleep medications. These complex sleep behaviors have also resulted in deaths.

This warning applies to eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) than other prescription medicines used for sleep.

Serious injuries and death from complex sleep behaviors have occurred in patients with and without a history of such behaviors, even at the lowest recommended doses, and the behaviors can occur after just one dose. These behaviors can occur after taking these medicines with or without alcohol or other central nervous system depressants that may be sedating such as tranquilizers, opioids, and anti-anxiety medicines.

Healthcare professionals should not prescribe eszopiclone, zaleplon, or zolpidem to patients who have previously experienced complex sleep behaviors after taking any of these medicines. Advise all patients that although rare, the behaviors caused by these medicines have led to serious injuries or death.

Tell the patient to discontinue taking these medicines if they experience an episode of complex sleep behavior.

Patients should stop taking insomnia medicine and contact their health care professional right away if they experience a complex sleep behavior leading to unusual activities while you are not fully awake.

FDA analyses identified 66 cases of complex sleep behaviors occurring with these medicines over the past 26 years that resulted in serious injuries, including death. These cases included accidental overdoses, falls, burns, near drowning, exposure to extreme cold temperatures leading to loss of limb, carbon monoxide poisoning, drowning, hypothermia, motor vehicle collisions with the patient driving, and self-injuries such as gunshot wounds and apparent suicide attempts.

Patients usually did not remember these events.

The underlying mechanisms by which these insomnia medicines cause complex sleep behaviors are not completely understood.

Disclosures: 
The author has no conflicts of interest to disclose related to this subject

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