FDA Issues Warning About Sleep Medication

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 products’ 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 “complex sleep-related behaviors, which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).” They define “sleep-driving” as “driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.”

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

Among the 13 products in the affected class of drugs are Sanofi’s Ambien, Sepracor’s Lunesta, and Lilly’s Seconal. The FDA also recommended that “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.”

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).

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