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.