FDA REQUESTS LABEL CHANGE FOR SLEEP DISORDER DRUGS

The FDA has requested that all manufacturers of sedative-hypnotic drug products strengthen their product labeling to include stronger language about potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving.

The recommendation is part of the agency's initiative to add warnings to the labeling of 13 sleep agents based on adverse event reports.

The FDA sent letters to manufacturers requesting the label warnings in December 2006, which should note "complex sleep-related behaviors, which may include sleep-driving, making phone calls and preparing and eating food (while asleep)," and the agency has been working with drugmakers during the past three months.

Along with the labeling revisions, FDA has requested that each product manufacturer send letters to healthcare providers to notify them about the new warnings. The FDA is also asking companies to produce medication guides and submit them for review by early May.

According to the FDA, the labeling changes will affect the following drugs: sanofi-aventis' Ambein/Ambein CR, Seprecor's Luesta, Takeda's Rozerem and King Pharmaceuticals' Sonata. Updates to labeling for Halicon, Prosom, Placidyl, Restoril, Seconal, Doral, Dalmane, Carbrital and butisol sodium were also requested.