FDA wants stronger warning for sleep disorder drugs.

FDA has requested that all manufacturers of popular sleep drugs such as Ambien and Lunesta add warnings that the products can cause odd and potentially dangerous behaviors such as driving while asleep as well as severe allergic reactions that warrant stronger warnings, the agency stated in a release March 14.

FDA called for the new cautions on 13 prescription sedative-hypnotic medications, but said its concerns were not serious enough to withdraw the drugs, "Yahoo News" also reported.

The medications that are the focus of the revised labeling include the following products:

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)

In December, FDA sent letters to these manufacturers requesting that the whole class of drugs revise product labeling to include warnings about the following potential adverse events:

* Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.

* Complex sleep-related behaviors that may include sleep-driving, making phone calls and preparing and eating food (while asleep).

Russell Katz, M.D., head of FDA's neurology division, told reporters he could not say how many cases of sleep-driving and other side effects had been reported but that they were rare. He added it was likely consumers and doctors underreported such incidents.

Most manufacturers have agreed to place the stronger warnings on their product labels except for one, which Katz declined to identify.

FDA also recommended that manufacturers of sleep drugs conduct trials to see how often the risks affect patients taking their particular product, as well as send letters to health care providers to notify them about the new warnings. Manufacturers will begin sending these letters to providers starting this week.