CME Teaching Brief® - MedPage Today - FDA Warns of Sedative-Aided Sleep Driving and Anaphylaxis

ROCKVILLE, Md., March 14 -- The FDA has taken steps to ensure that clinicians and patients are aware of rare bizarre effects associated with sedative hypnotics, including driving or eating while sleeping.

The agency has ordered makers of all sedative-hypnotic drugs to strengthen label warnings about the risk of "complex sleep-related behaviors" and also severe allergic reactions. The FDA defined sleep driving as "driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event."

Last December, the FDA sent letters to manufacturers of products approved for the treatment of sleep disorders requesting that the whole class of drugs revise product labeling to include warnings about the following potential adverse events:

Anaphylaxis and severe facial angioedema, which can occur the first time the product is taken. Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food while asleep.

"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, the FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks."

Russell Katz, M.D., director of the FDA's division of neurology products at the center, said the new label will warn that a number of complex-sleep related behaviors "including cooking and eating, using the telephone, having sex, and driving" have been reported by persons using the drugs. Typically, the patient has no memory of these actions.

At a press briefing today, Dr. Katz repeatedly emphasized that the allergic reactions, including anaphylaxis and angioedema, and the complex sleep-related behaviors,"are rare by any definition" and he said the FDA has not received any reports of death associated with either side effect....[MORE]