FDA strengthening warnings for some popular sleep aids

A ‘Black Box’ warning was issued for insomnia drugs Ambien, Edluar, Zolpimist, Lunesta, Sonata and others.

FDA strengthening warnings for some popular sleep aids
The Food and Drug Administration said it would require some commonly prescribed sleep aids to carry the agency’s toughest boxed warning about serious risks following reports of at least 20 deaths.

(CNN) - The Food and Drug Administration is strengthening warnings about some commonly used sleep aids.

Sleeping pills marketed under the names Lunesta, Sonata and Ambien, as well as three formulations of zolpidem, the generic name for Ambien. will require new black-box warnings for potentially dangerous side-effects.

The FDA says 20-deaths have been blamed on the pills.

“These cases included accidental overdoses, falls, burns, near drowning, exposure to extreme cold temperatures leading to loss of limb, carbon monoxide poisoning, drowning, hypothermia, motor vehicle collisions with the patient driving, and self-injuries such as gunshot wounds and apparent suicide attempts,” the agency reported. “Patients usually did not remember these events.”

The new ruling requires that labels must note that side effects include risky behaviors, such as sleepwalking and sleep driving, that can lead to injury and even death.

“Patients, stop taking your insomnia medicine and contact your health care professional right away if you experience a complex sleep behavior where you engage in activities while you are not fully awake,” the agency’s safety alert said, “or if you do not remember activities you have done while taking the medicine.”

According to the Centers for Disease Control and Prevention 4 percent of adults have used prescription sleep aids in the past month.

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