The U.S. Food and Drug Administration (FDA) has warned consumers about the risk of serious side effects connected with a range of sleep-disorder drugs and has asked drug manufacturers to strengthen their productsÃ¢â‚¬â„¢ label warnings. The new warnings highlight the risk of severe allergic reactions and erratic and dangerous sleep-related behavior.
The agency warned that anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling) can occur as soon as the first dose is taken. They also point to Ã¢â‚¬Å“complex sleep-related behaviors, which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).Ã¢â‚¬Â They define Ã¢â‚¬Å“sleep-drivingÃ¢â‚¬Â as Ã¢â‚¬Å“driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.Ã¢â‚¬Â
Ã¢â‚¬Å“There are a number of prescription sleep aids available that are well-tolerated and effective for many people,Ã¢â‚¬Â said Dr. Steven Galson, director of the FDAÃ¢â‚¬â„¢s Center for Drug Evaluation and Research. Ã¢â‚¬Å“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.Ã¢â‚¬Â
Among the 13 products in the affected class of drugs are SanofiÃ¢â‚¬â„¢s Ambien, SepracorÃ¢â‚¬â„¢s Lunesta, and LillyÃ¢â‚¬â„¢s Seconal. The FDA also recommended that Ã¢â‚¬Å“the drug manufacturers conduct clinical studies to investigate the frequency with which sleep-driving and other complex behaviors occur in association with individual drug products.Ã¢â‚¬Â
Evidence of abnormal sleep-related behavior has been mounting in recent months. A year ago, the New York Times ran a series of articles describing abnormal sleep-related behavior in patients taking Ambien. A study by researchers at the Minnesota Regional Sleep Disorders Center discovered that a sleep-related eating disorder (basically, binge eating while sleeping) was a side effect of growing concern among Ambien users. The Times also reported on the sleep-driving phenomenon among Ambien users last March.
The other 10 sedative-hypnotics in question are: Butisol Sodium (Medpointe Pharm HLC), Carbrital (Parke-Davis), Dalmane (Valeant Pharm), Doral (Questcor Pharms), Halcion (Pharmacia & Upjohn), Placidyl (Abbott), Prosom (Abbott), Restoril (Tyco Healthcare), Rozerem (Takeda), and Sonata (King Pharmaceuticals).