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FDA Lowers Dose Recommendation for Sleep Aid Lunesta

Filed May 16th, 2014 Eric

The U.S. Food and Drug Administration (FDA) is warning the public that the insomnia drug Lunesta (eszopiclone) can cause next-day impairment of driving and other activities that may require a person to be alert.

Based on that warning, the FDA has lowered the recommended starting dose of Lunesta to 1 mg at bedtime.  The agency advices health care professionals to follow the new dosing recommendations when starting patients on Lunesta.  Meanwhile, patients are instructed to continue taking their prescribed dose of Lunesta and contact their health care professionals to ask about the most appropriate dose for them, according to the FDA update.  

The FDA previously recommended a 3 mg dose, but changed its stance after a study of Lunesta found that a dose of 3 mg can cause impairment to driving skills, memory, and coordination that can last more than 11 hours after receiving an evening dose. The study was conducted on 91 healthy adults ages 25 to 40. The study showed, compared to an inactive pill (placebo), Lunesta 3 mg was associated with severe next-morning psychomotor and memory impairment in both men and women 7.5 hours after taking the drug. Of great concern was that patients were often unaware they were impaired the next day.  The new lower recommended starting dose of 1 mg at bedtime will result in less drug in the blood the next day, according to the FDA notice.

The study found that men and women are equally susceptible to impairment from Lunesta, so the recommended starting dose of 1 mg is the same for both.  The agency said the dose can be increased to 2 mg or 3 mg when necessary, but the higher doses are more likely to result in next-day impairment of driving and other activities that require full alertness.  The FDA cautions patients taking a 3 mg dose against driving or engaging in other mental activities the day after use.

The FDA has approved changes to the Lunesta prescribing information and the patient Medication Guide to include the new recommendations.  The drug labels for generic eszopiclone products will also be updated to include these changes.

More changes to the sleep aid market could also be on the way as the FDA is continuing to evaluate the risk of impaired mental alertness with the entire class of drugs. The agency is also looking at over-the-counter drugs available without a prescription, and will update the public as new information becomes available.

“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,” Ellis Unger, M.D., director, Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research said in an FDA press release. “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.”

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