FDA: New label warnings required for sleep drugs

The U.S. Food and Drug Administration (FDA) has asked manufacturers of sleeping pills to strengthen their product labeling to include stronger language concerning potential risks.

This action came about after the FDA determined that these medications -- including popular brands such as Ambien®, Lunesta®, and Sonata® -- can cause strange and possibly dangerous side effects that consumers may not be aware of.

One type of side effect that the FDA is most concerned about is a kind of allergic reaction called anaphylaxis, a severe systemic response that is potentially life-threatening. Another serious type of allergic reaction that is possible is called angioedema, which causes severe swelling of the face, mouth, throat and tongue. While only a small number of people are likely to experience these severe reactions, they can occur without warning, as early the first time of the drug is taken.

The FDA also wants labels on sleeping pills to warn consumers about peculiar sleep-related behaviors that have been reported in some people who took these drugs. These include 'sleep-driving,' making phone calls, and preparing and eating food (while asleep) -- and not remembering afterward.

If you take any kind of prescription sleeping aid, click here to see if your brand is on the FDA warning list.

"There are a number of prescription sleep aids available that are well-tolerated and effective for many people," said Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation and Research. "However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks."

For more information and news about sleep, visit the Sleep News page on the AircrewHealth.com website.