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Ambien and other prescription sleep medications are getting a new "black box" warning label from the U.S. Food and Drug Administration (FDA). This type of label is the strongest that the agency issues, calling attention to side effects that can lead to serious injury or death.
FDA representatives wrote yesterday (April 30) The change follows the FDA's evaluation of reports describing "rare but serious" incidents that occurred when users of these medications experienced complex sleep behaviors: sleepwalking, sleep driving, and engaging in other activities while not fully awake ) in a drug safety announcement.
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Ambien (generic name zolpidem), Sonata (generic name zaleplon), Lunesta (generic name eszopiclone), and others, according to the announcement. [7 Bizarre Drug Side Effects]
Another of the FDA 's most stringent warnings – a contraindication, which recommends avoiding a drug under certain conditions – will also be included.
The FDA investigated data spanning 26 years, and found 66 examples of complex sleep behaviors associated with these medications. Patients performed before or after exposure to extreme cold; There have been instances of carbon-monoxide poisoning, drowning, apparent suicide attempts, self-inflicted gunshot wounds and crashes – with the patient at the wheel.
In most cases, the patient did not remember the incidents that led to their injuries, according to the FDA.
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As these findings have been based on FDA, it has been possible that FDA reports that it is possible that FDA has reported that FDA officials said.
Millions of Americans experience insomnia and rely on medication to help them sleep, "FDA Acting Commissioner Dr. Ned Sharpless said in a statement.
"These incidents may occur after the first dose of these patients or after a period of treatment, and may occur in the patients at any rate," Sharpless said.
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FDA officials said that these medications trigger complex complex sleep behaviors that can lead to injury. Dr. Janet Woodcock, director of the FDA 's Center for Drug Evaluation and Research, said in the statement, "The agency will continue to monitor medical insomnia and evaluate the risks.
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Originally published on Live Science.
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