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FDA Requests Stronger Risk Labeling on Sleep Drugs

Adverse reactions to sedative-hypnotic drugs include allergic reaction and sleep-driving

THURSDAY, March 15 (HealthDay News) -- The U.S. Food and Drug Administration has requested that the manufacturers of 13 prescription sleep aids re-label the products to better reflect the potential risks. The new warnings, which differ for each drug, include anaphylaxis and angioedema, and complex sleep-related behaviors such as driving, making phone calls and preparing and eating food while asleep.

In addition to the labeling revisions, the FDA has requested that manufacturers of sedative-hypnotic drugs notify health care providers about the new warnings and develop patient medication guides carrying FDA-approved information on the drugs.

"There are a number of prescription sleep aids available that are well-tolerated and effective for many people. 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," said Steven Galston, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research, in a statement.

The medications affected are Ambien/Ambien CR, Butisol Sodium, Carbrital, Dalmane, Doral, Halcion, Lunesta, Placidyl, Prosom, Restoril, Rozerem, Seconal and Sonata.

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