FDA Calls for Change in Lunesta Drug Label and Reduction in Starting Dose

The U.S. Food and Drug Administration called for changes to be made in the drug label of the sleep drug Lunesta and also lower the current recommended starting dose.

In a latest announcement, the federal regulators claimed that the manufacture of the sleep drug Eszopiclone (Lunesta) should alter its drug label and also lower the starting dose as this sleep aid drug triggers the risk of impairment the morning after use.

The data reveals that the level of the drug which is mostly taken during the bedtime may be high for some patients the morning after the use. And this high level of eszopiclone impairs activities that demand alertness, including driving even if they feel fully awake.

After this call made by the federal regulators, the manufacturers have lowered the starting dose of Lunesta from 2 milligrams to 1 milligram for both men and women.  And this 1 mg can later be increased to 2 mg or 3 mg based on the requirement but as mentioned earlier, intake of higher dose is known to cause impairment the next day in driving and other activities. With the intake of low dose, the drug stays in the body in the morning hours.

The patients taking 2mg or 3 mg doses of Lunesta should contact their health care professuional and seek instructions on how to continue taking the medicines at the dose that is actually needed.

"To help ensure patient safety, health care professionals should prescribe, and patients should take, the lowest dose of the sleep medicine that effectively treats their insomnia," said Ellis Unger, M.D., director, Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research. "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."'

After lowering the starting dose, a study was conducted on 91 healthy adults of age 25-40. The participants were randomly given either a placebo or the drug.  The researchers noticed that when compared to the placebo, 3mg of Lunesta  was linked to severe psychomotor and memory impairment in men and women, 7.5 hours after taking the drug. 

They also found that the intake of recommended doses can trigger impairment to driving skills, memory and coordination for nearly 11 hours after the intake of the drug. 

The common side effect for all insomnia drug was drowsiness.  The FDA is continuing to evaluate the risk of impaired mental alertness with the entire class of sleep drugs, including over-the-counter drugs, and will update the public as new information becomes available.