FDA strengthens warnings on sleep drugs

Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event. Along with the labeling revisions, the FDA has requested that each product manufacturer send letters to health care providers to notify them about the new warnings. The medications include Sanofi-Aventis’ Ambien and Abbott’s Placidyl.

“There are a number of prescription sleep aids available that are well-tolerated and effective for many people,” said Steven Galson, 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.”

Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as 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 still asleep.