The condition is common in people who take sleeping pills and other sedative-hypnotic drugs indicated to induce or maintain sleep. The FDA has now asked the manufacturers of these drugs to include strong language in their product labeling to warn about sleep driving, as well as other potential risks.
The FDA has reportedly compiled more than a dozen reports of sleep-walking and more are expected to pour in now. The most widely covered case of sleep-driving occurred almost a year ago when Rep. Patrick Kennedy crashed his car after taking Ambien. The Congressman said he had no memory of the event but pleaded guilty to driving under the influence of prescription drugs. He was sentenced to court-ordered drug treatment and a year's probation.
Keeping in mind the seriousness of the problem of sleep driving, the FDA ordered a series of strict new steps Wednesday for the makers of 13 sleep drugs. It includes putting warnings on their labels about the rare but serious side effects like sleep-driving, making phone calls and even eating.
By the end of 2007, the FDA said that all prescription sleeping pills will come with special brochures called "Medication Guides" that would warn about the potential risks for patients in a simple language.
Experts have strictly advised against taking any prescription insomnia drug along with alcohol or any other sedating drug. The FDA also added that higher-than-recommended doses of the pills should never be taken.
The drugs involved in the announcement are: Ambien; Butisol sodium; Carbrital; Dalmane; Doral; Halcion; Lunesta; Placidyl; Prosom; Restoril; Rozerem; Seconal and Sonata.
