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FDA wants stronger warnings for sleep disorder drugs

Mar 14, 2007 | AP

All sleeping pills, including the blockbusters Ambien and Lunesta, may sometimes cause a bizarre but dangerous side effect, sleep-driving, the Food and Drug Administration warned Wednesday.

It's like sleepwalking but behind-the-wheel: driving while not fully awake after using a sleeping aid with no memory of doing so.

The FDA ordered the makers of 13 products to strengthen warnings on their labels about two rare but serious side effects:

  • Sleep-driving, along with other less dangerous "complex sleep-related behaviors'' like making phone calls or fixing and eating food while still asleep.
  • And life-threatening allergic reactions, as well as severe facial swelling, both of which can occur the first time the pills are taken.

FDA told manufacturers to write letters to doctors to notify them of the new warnings, and all prescription sleeping pills now will come with special brochures called "Medication Guides'' that spell out the risks for patients in easy-to-understand language.

FDA wouldn't say exactly how many cases of sleep-driving it uncovered, or if it knew of any car crashes, saying only that "there have been rare adverse events reported.''

"Due to the potential for embarrassment and/or legal exposure, people are less likely to report some of the more complex sleep behaviors. Therefore, FDA is concerned that there may be extensive under-reporting of these events,'' said FDA spokeswoman Kimberly Rawlings. "It was important to alert people about the risk of complex sleep behaviors, especially sleep-driving because of the potential for this activity to cause harm or death to both the patients and the community.''

This entire class of medicine, known as sedative-hypnotic products, has these rare risks, FDA said. But some drugs may cause the problems more than others, so FDA recommended that manufacturers conduct clinical trials to figure that out.

The drugs are: Ambien; Butisol sodium; Carbrital; Dalmane; Doral; Halcion; Lunesta; Placidyl; Prosom; Restoril; Rozerem; Seconal; Sonata.


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