FDA Warns Against Sleeping Pills

Research indicates 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. Patients usually did not remember these events.”

Rare but serious injuries have occurred with certain common prescription insomnia prescriptions according to the US FDA, and reports of the unusual side effects have grown as use of these pills has increased. As a result sleeping pill manufacturers must now include a prominent Boxed Warning on all medication guides for Ambien, Lunesta, Sonata, Zolpidem, Edluar, Intermezzo, Zolpimist, and other prescription medicines used for sleep.

The FDA has also mandated a separate Contraindication warning against prescribing these drugs to anyone with a history of sleepwalking or complex sleep behavior with eszopicolne, zaleplon, and zolpidem. In addition to warning against use of alcohol the new labels must also warn that these pills should not be taken with other drugs that suppress the nervous system, and describe the side effects of their specific drugs.

This new FDA guideline will affect newer products as well as older and more commonly used drugs that are sold under brand names as well as generic names. Many of these drugs currently carry warnings against alcohol use and risk of hallucinations, now those statements must be more prominent, and their inserts must emphasize the risks when prescriptions are filled. Information is to be included about the rare risk of life threatening allergic reactions, such as some case have reported air passages or faces swelling up after using Rozerem, and other reports of sleep driving and sleep eating involving Ambien.

In addition to the new labelling and insert guidelines the agency is also recommending that the drug makers conduct additional clinical studies involving sleep driving and other adverse reactions to determine whether or not these pill cause these problems. However this is only a suggestion not a requirement, thus far none of the companies have announced plans to conduct any studies according to Dr. Katz, director of neurology products at the FDA.

University of Minnesota has been studying cases of Ambien users who have developed unusual nighttime eating disorders according to Dr. Carlos H. Schenck and Dr. Mark W. Mahowald.

“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.” says Ilene Rosen, physician at the University of Pennsylvania.

This is not the first time the FDA has warned against sleeping pills, over 12 years ago the FDA first issued a public warning against strange sleeping behavior, this new warning is upping the ante in which agency officials say the activities associated with the drugs go beyond mere sleepwalking. Drinking alcohol before or after taking these drugs appears to increase chances of having a reaction according to Dr. Katz.

In 2007 the US FDA warning followed a warning from authorities in Australia, the agency there cited 16 reports of unusual activities including sleep driving and sleep eating, one person woke up with a paintbrush in hand to discover she had painted her front door of her home while asleep involving Ambien which was marketed as Stilnox.