FDA Warns that Lunesta May Lead to Next Day Impairment, Lowers Recommended Dose

FDA_lunestaThe U.S. Food and Drug Administration (FDA) just issued a warning that Lunesta (eszopiclone), the insomnia drug, may lead to what is known as next-day impairment of driving and other activities that require people to remain alert.

Because of this, the agency has decreased the recommended starting dose of Lunesta to 1 mg at bedtime and advises care professionals to adhere to the new dosing recommendations when patients are starting to take Lunesta. As for patients, they should continue to take their prescribed dose of Lunesta and contact their health care professionals to understand the most appropriate dose for them.

A study of Lunesta revealed that the previously recommended dose of 3 mg may lead to impaired driving skills, memory, and coordination that may continue for more than 11 hours following the evening dose. Meanwhile, according to the FDA, patients were often unaware that they were driving while impaired and believed that they were aware, despite having concentrations of the drug in their bloodstream many hours after taking the drug. The revised, reduced recommended starting dose of 1 mg at bedtime will result in less drug in the blood the following day.

Because women and men are both similarly susceptible to Lunesta impairment, the recommended 1 mg starting dose is the same for both sexes. Although the 1 mg dose may be increased to 2 mg or 3 mg, if necessary, the increased doses are likelier to lead to next-day impairment. The FDA cautions patients who take the 3 mg Lunesta dose that they should not drive or become involved in any activities that may call for complete mental alertness the day following their taking of the higher dose.

The FDA also indicated that it had approved changes to Lunesta prescribing information and the patient Medication Guide that will include these new recommendations and that labeling for the generic versions of eszopiclone will be updated, as well.

“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,” 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.”

The dose change was partly based on study findings involving 91 healthy adults from the ages of 25 to 40. The study revealed that, when compared to a placebo, Lunesta in the 3 mg dose was tied to severe next-morning psychomotor and memory impairment in men and women 7.5 hours after they had taken the drug. The study also revealed that recommended doses may lead to driving skill impairment and impairment of memory and coordination as late as 11 hours after Lunesta was taken. Despite the long-lasting effects, patients were often unaware they were impaired, according to the FDA.

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