WASHINGTON, May 15 (UPI) -- The U.S. Food and Drug Administration said Thursday the manufacturer of the the sleep medication Lunesta, or eszopiclone, must change the label to recommend a lower starting dose.
FDA officials said data showed eszopiclone levels in some patients might be high enough the morning after the user takes the sleep medication to impair alertness and the ability to drive -- even if people say they feel fully awake.
Dr. Ellis Unger, director of the Office of Drug Evaluation at the FDA's Center for Drug Evaluation and Research, said the recommended starting dose of Lunesta has been decreased from 2 milligrams to 1 mg for men and women. The higher dose is more likely to result in next-day impairment of driving and other activities.
The 1 mg dose can be increased to 2 mg or 3 mg if a doctor determines it is needed, but the higher doses are more likely to result in next-day impairment.
"To help ensure patient safety, healthcare professionals should prescribe, and patients should take, the lowest dose of a sleep medicine that effectively treats their insomnia," Unger said in a statement.
"Recently, data from clinical trials and other types of studies have become available, which allowed the FDA to better characterize the risk of next-morning impairment with sleep drugs."
A study of 91 healthy adults ages 25 to 40 were given either 3 mg of Lunesta or a placebo.
The study found the higher doses could cause impairment to driving skills, memory and coordination 11 hours after the drug was taken, yet patients said they were often unaware they were impaired.