Insomnia drugs should contain stronger labels warning about potential adverse events, including driving while not fully awake, the FDA said.
The labeling change applies to the entire class of drugs approved for sleep disorders, which includes Sanofi-Aventis’ Ambien and Ambien-CR, Sepracor’s Lunesta, Takeda’s Rozerem and Tyco Healthcare's Restoril, which is also sold generically.
Those firms and eight others should alert health providers about the risks and develop medication guides for patients, FDA said. Besides sleep-driving, patients taking the drugs may find themselves making phone calls and preparing and eating food while asleep, FDA said. Other risks may include anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling).
FDA said it decided to call for the label change after reviewing post-marketing adverse event information.
Last year a barrage of anecdotal reports of binge-eating and other odd patient behavior compelled Sanofi-Aventis to launch a print ad campaign with advice on proper use of Ambien. Sales of drugs in the class had suffered in the wake of the reports.
Sanofi, the market leader in the insomnia category, told MM&M Wednesday that information about a "rare" risk of sleepwalking -- fewer than one in 1,000 cases -- has always been included on the Ambien label. A Dear Doctor letter appeared on its site following the FDA announcement, and Sanofi said it will inform US healthcare professionals about the label revisions.
However, an FDA official told The New York Times that the activities associated with insomnia drugs go beyond mere sleepwalking.
"These behaviors are complex and they're different fundamentally because of the complexity," the official told the newspaper. "People get up, they take their car keys and they go drive. As you might imagine, that might be potentially dangerous to the patient and others as well."
FDA also advised the firms to study behaviors like sleep-driving in clinical trials, specifically the frequency with which such behaviors occur in patients taking their products.
Drafts of the patient medication guides are due by next May, noted the Times.