Sleep medications including Ambien, have been prompting people to act weirdly when they are in a semi-sleeping stupor, which is why the U.S. Food and Drug Administration (FDA) has asked sleep medication manufacturers to mention a black box warning on the labels.
According to FDA research, “Harrowing incidents related to sleeping pills have 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 wrote, “Patients usually did not remember these events.”
On Tuesday, the FDA announced that a black box warning would be required on all sleep medications such as Lunesta (eszopiclone), Sonata (zaleplon), and Ambien, Edluar, Intermezzo and Zolpimist (zolpidem).
The FDA has also mandated a separate warning to doctors against prescribing the drugs to patients with a history of “complex sleep behavior.”
This is not the first time the FDA has taken the steps to warn against sleep medications. The New York Times reports that the agency had issued a public warning against strange sleeping behavior nearly 12 years ago, which means that this new warning is to merely raise the stakes. Dr. Ilene Rosen of the University of Pennsylvania told The New York Times, “I am surprised to see this warning come out now. This is something I’ve been telling my patients for the last 15 years, and in the sleep community this is well known. And I’d like to think we’ve done a good job putting the news out there, that these drugs have some risks.”
