May 24, 2019—The U.S. Food and Drug Administration (FDA) will now require its most serious type of warning—a boxed warning—to appear on some prescription insomnia drugs. The warning follows reports of serious injuries and even deaths resulting from what FDA calls "complex sleep behaviors" after taking the drugs.
These behaviors include things like sleepwalking, sleep driving and using a stove while asleep.
The new boxed warning will be required for these drugs:
- Eszopiclone (Lunesta).
- Zaleplon (Sonata).
- Zolpidem (Ambien, Ambien CR, Edluar, Intermezzo and Zolpimist).
FDA acknowledges that these sleep behaviors are rare. Still, they can result in serious injuries.
The agency reviewed 66 reported cases of strange sleep behaviors in people taking the drugs. Forty-six of these resulted in injuries such as:
- Accidental overdoses.
- Exposure to cold temperatures, leading to loss of limb or near death.
- Self-injuries, such as gunshot wounds and apparent suicide attempts.
In addition, 20 deaths occurred from:
- Carbon monoxide poisoning.
- Fatal falls.
- Traffic accidents.
- Apparent suicide.
These behaviors can occur the first time someone uses these medicines or after a longer period of treatment. They can also occur in people without any history of these kinds of behaviors. And they may happen even at the lowest dose of the medicines.
According to FDA, people who have experienced any complex sleep behaviors after taking the medicines should stop taking them. And the agency urges people to tell their doctor and FDA about any strange sleep events or other side effects.
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