New Warning on Sleep Drugs

The Food and Drug Administration says all prescription insomnia drugs should have tougher labels that warn users they could have severe allergic reactions or unknowingly attempt potentially dangerous activities, such as trying to drive while still asleep.

In addition to strengthening the labels of their products, makers of sedative-hypnotic drugs need to send notices to health care providers and prepare medication guides for patients, the agency says.

The FDA's action, announced Wednesday, covers 13 drugs, most notably Ambien and Ambien CR from Sanofi-Aventis(SNY Quote), Lunesta from Sepracor(SEPR Quote), Rozerem from Takeda and Sonata from King Pharmaceuticals(KG Quote). ...