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, Lunesta from Sepracor, Rozerem from Takeda and Sonata from King Pharmaceuticals.
“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.”
Some people taking the drugs have been known to drive, make phone calls or eat while they were effectively asleep or not fully awake. People experiencing these side effects generally have no memory of what they did.
The FDA sent letters to drugmakers in December telling them to revise their products’ labels. The agency said the companies are sending warning letters to doctors and other health care professionals this week.
Although all sedative-hypnotic drugs can cause behavioral side effects, “there may be differences among products in how often they occur,” the FDA says. The agency has asked companies to conduct clinical tests “to investigate the frequency with which sleep-driving and other complex behaviors occur” due to their products.