No Longer Accepting Cases

May 15, 2014 — The insomnia drug Lunesta (eszopiclone) can cause next-day drowsiness that can impair driving and other activities that require alertness. Therefore, the U.S. Food and Drug Administration (FDA) recommends limiting the starting dose to 1-mg at bedtime.

Recent data from clinical trials and other studies has shown that the previous recommended starting-dose of 3-mg caused severe impairment to coordination, driving skills, and memory.

The effects were worst 7.5 hours after dosing. Impairment was still present 11.5 hours later. Some patients said they did not feel drowsy, but tests showed that they were impaired. Researchers’ conclusions were based on data from 91 healthy adults between the ages of 25 and 40.

Dr. Ellis Unger, director of the Office of Drug Evaluation, said in the FDA news release:

“To help ensure patient safety, health care professionals should prescribe, and patients should take, the lowest dose of a sleep medicine that effectively treats their insomnia.”

Doctors are still allowed to prescribe higher doses of Lunesta. However, patients taking a 3-mg dose are cautioned against driving or engaging in other activities that are hazardous or require complete mental awareness the day after use.

Researchers found that the 3-mg dose of Lunesta caused similar impairment as 7.5-mg of zopiclone, a drug that is often used as a positive control in driving impairment studies. Zopiclone is not approved in the United States.

One year ago, the FDA made a similar recommendation to cut the starting dose of Ambien (zolpidem), especially in women and those taking extended-release versions of the drug. In the case of Lunesta, the FDA said they saw no difference in men and women, and recommended the 1-mg starting dose for all patients.