Ambien, Other Sleep Aids Get FDA's Strongest Warning

Injuries and deaths lead to adding 'black box' labels
By Bob Cronin,  Newser Staff
Posted May 2, 2019 6:30 PM CDT
Ambien, Other Sleep Aids Get FDA's Strongest Warning
The Food and Drug Administration campus in Silver Spring, Md., in 2015.   (AP Photo/Andrew Harnik, File)

The FDA is requiring its strongest warning labels be placed on Ambien, Sonata, Lunesta, and other prescription sleep medications. The "black box" label warns that side effects can lead to serious injury or death, Live Science reports. The FDA ordered the change after "rare but serious" incidents among users of the medications including sleepwalking, sleep driving "and engaging in other activities while not fully awake," the announcement said. The medications help patients fall asleep or stay asleep by slowing brain activity. The government says nearly 30 million prescriptions of the three drugs were filled in the US last year.

The FDA found 66 examples of complex sleep behavior in 26 years in which a patient was injured or killed after taking insomnia medications with the generic names eszopiclone, zaleplon or zolpidem, per USA Today. The deaths were caused by carbon monoxide poisoning, drowning, falls, hypothermia, car accidents in which the patient was driving, and apparent suicide. "These incidents can occur after the first dose of these sleep medicines or after a longer period of treatment," acting FDA Commissioner Ned Sharpless said, "and can occur in patients without any history of these behaviors and even at the lowest recommended doses." (The FDA has required dosages to be cut in the past.)

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