FDA Strengthens Warnings on Sleeping Pills

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By Steven Reinberg
HealthDay Reporter
Wednesday, March 14, 2007; 12:00 AM

WEDNESDAY, March 14 (HealthDay News) -- Prescription sleeping pills, including such popular brands as Ambien and Lunesta, can cause strange and potentially dangerous side effects, the U.S. Food and Drug Administration warned Wednesday.

Those side effects can include dangerous allergic reactions and bizarre behaviors such as "sleep-driving," in which a person will drive a car while not fully awake and have no memory of doing so.

The FDA is asking makers of the sleep aids, called sedative-hypnotic drugs, to strengthen product labels to include stronger warnings about the potential risks. In addition to "sleep-driving," the agency said it has received reports of consumers walking or eating while not fully awake, and not remembering it later.

"Because these drugs are designed to put people to sleep, they might not know that they are having a side effect," Dr. Russell Katz, director of the FDA's Division of Neurology in the Office of Drug Evaluation I, Center for Drug Evaluation and Research, said during a teleconference.

Sleep-driving and other strange behaviors might occur if consumers take a higher-than-recommended dose of the drug, or drink alcohol or consume other similar drugs, Katz said. "We believe that all the drugs in the class can produce these effects," he said.

Katz said it's not possible to know how many cases of these side effects have occurred because the system for reporting adverse effects is voluntary. "We believe these are rare occurrences," he said. "But we don't know the actual number of cases."

The 13 drugs involved are: Ambien and Ambien CR, made by Sanofi Aventis; Butisol Sodium, made by Medpointe Pharm HLC; Carbrital, made by Parke-Davis; Dalmane made by Valeant Pharm; Doral made by Questcor Pharms; Halcion, made by Pharmacia & Upjohn; Lunesta, made by Sepracor; Placidyl and Prosom, made by Abbott; Restoril, made by Tyco Healthcare; Rozerem, made by Takeda; Seconal, made by Lilly; and Sonata, made by King Pharmaceuticals.

Last December, the FDA sent letters to the drug makers, asking them to revise their product labels to include warnings about the potential for severe allergic reactions -- called anaphylaxis -- and severe facial swelling -- called angioedema.

At that time, the FDA also asked the manufacturers to add warnings about complex sleep-related behaviors, including sleep-driving, making phone calls, and preparing and eating food or having sex while asleep, Katz said.

In addition to these label changes, the FDA is asking the manufacturers to send letters to health-care providers notifying them about the new warnings. These will start going out this week, according to the FDA.

The FDA has also asked the drug manufacturers to develop "Patient Medication Guides" to inform people about the risks associated with these drugs and precautions they can take. These guides will be given to patients when one of these drugs is prescribed. There is no deadline for the availability of these guides, Katz said.

Katz said people can minimize their risk of side effects by taking only the prescribed dose and not mixing the drugs with alcohol or other medicines that have similar effects.


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