FDA Calls for Stronger Label Warnings on Sleep Medication

The Federal Drug Administration has called for the addition of stronger warning labels on the packaging of prescription sleep aid medications such as Ambien, Lunesta, and Sonata. The request has come after numerous reports of erratic and potentially harmful behavior exhibited by patients using the medications.

The drugs in question are members of a class of prescription pharmaceuticals referred to as sedative-hypnotics that induce of lengthen sleep. Patients have complained of side effects that include sleep eating, sleep driving, and other reckless behaviors such as drug use and high risk sex.

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

The side effects of the prescription sleep aid Ambien made headlines in March of 2006. Users of the drug reported episodes of binge eating during the night that they did not remember in the morning. Patients would find food and candy wrappers throughout their homes but could not recall eating the food. One woman, unable to determine why she had gained over 100 pounds, went as far as to set a video recorder on her refrigerator before going to sleep at night.

In the statement released by the FDA on March 14, 2007, a warning is also issued about the risk of sleep driving. According to the FDA, sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event. Users of prescription sleep aids have previously been involved in traffic accidents.

A total of 13 different prescription sleep medications were listed to receive new warning labels (manufacturer names are listed in parenthesis): Ambien/Ambien CR (Sanofi Aventis), Butisol Sodium (Medpointe Pharm HLC), Carbrital (Parke-Davis), Dalmane (Valeant Pharm), Doral (Questcor Pharms), Halcion (Pharmacia & Upjohn), Lunesta (Sepracor), Placidyl (Abbott), Prosom (Abbott), Restoril (Tyco Healthcare), Rozerem (Takeda), Seconal (Lilly), Sonata (King Pharmaceuticals).

The number of Americans suffering from insomnia is estimated at over 70 million according to the American Academy of Sleep Medicine. In 2005 over 43 million prescriptions for sleep aids were filled by pharmacists, a number expected to have increased in 2006.

Sources: FDA

CBS News

American Academy of Sleep Medicine