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(Newser)
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The FDA requires that its strictest warning labels be affixed to the drugs prescribed for sleep Ambien, Sonata, Lunesta and others. The "black box" label warns that side effects can result in serious injury or even death, reports Live Science. The FDA ordered the change after "rare but serious" incidents among drug users, including sleepwalking, drowsy driving "and engaging in other activities without being fully awake," the statement said. Medications help patients to fall asleep or stay asleep by slowing down brain activity. The government said that nearly 30 million prescriptions of the three drugs had been met in the United States last year.
The FDA has identified 66 examples of complex sleep behavior in 26 years in which a patient had been injured or killed after taking insomnia medications bearing the generic names eszopiclone, zaleplon or zolpidem, according to USA Today. The deaths were caused by carbon monoxide poisoning, drowning, falls, hypothermia, car accidents in which the patient was driving and an apparent suicide. "These incidents may occur after the first dose of these sleeping pills or after a longer period of treatment," said Acting FDA Commissioner Ned Sharpless, "and may occur in patients with no history of these behaviors and even at the lowest recommended doses. " (The FDA has required that dosages be reduced in the past.)
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