Some of the most popular prescription sleep aids will now carry a black box warning, the FDA’s most prominent warning, which will be included in the information given to patients when they pick up the pills.
“Rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake,” the FDA said Tuesday. “These complex sleep behaviors have also resulted in deaths.”
And, the FDA claims the prescription sleep aids most often linked to these incidents are eszopiclone (brand name “Lunesta”), zaleplon (brand name “Sonata”) and zolpidem (brand names “Ambien,” “Ambien CR,” “Edluar,” “Intermezzo,” “Zolpimist”).
“They are in a class of medicines called sedative-hypnotics and have been approved and on the market for many years,” the FDA said. “These insomnia medicines work by slowing activity in the brain to allow sleep.”
The FDA advises those who suffer a loss of memory or one of the aforementioned sleep events to stop taking the sleep aid and contact a health care professional. To doctors, the government agency says don’t prescribe any of the above sleep aids to those who’ve had a “complex sleep behavior.”
To report a serious adverse event, visit the FDA website.