FDA Cuts Lunesta Dose in Half

According to its manufacturer, 31 million prescriptions have been written for the sleep drug Lunesta, but its standard dose is dangerous, and the FDA is recommending that it be cut in half.

Known generically as eszopiclone, the drug’s levels in some people may remain high enough the morning after they use it to impair alertness. For many people, even if they feel fully awake, driving, using machinery and other activities can be dangerous.

Last year, we wrote about the dangers of another sleep aid, Ambien and similar drugs, whose dose the FDA required to be reduced. At the time, the feds did not include Lunesta in those revisions because its active ingredient is different from zolpidem, the one in Ambien, but the agency was looking at its safety all along.

“To help ensure patient safety,” according to the announcement, “health-care professionals should prescribe, and patients should take, the lowest dose of a sleep medicine that effectively treats their insomnia,” Dr. Ellis Unger, director of the FDA’s Office of Drug Evaluation, said.

The recommended starting dose of eszopiclone is now 1 mg for both men and women.

“The 1 mg dose can be increased to 2 mg or 3 mg if needed, but the higher doses are more likely to result in next-day impairment of driving and other activities that require full alertness,” the FDA said.

As explained on Medscape.com, the new guidelines are based partly on a study of 91 healthy adults ages 25 to 40 showing that 3 mg of eszopiclone was associated with severe next-morning psychomotor and memory impairment in both men and women compared with a placebo, or fake pill. The effects were notable 7.5 hours after they took the drug. And in some people, the impairment can last as long as 11 hours. “Despite these long-lasting effects, patients were often unaware they were impaired,” the FDA said.

The agency continues to evaluate the entire class of sleep drugs, including those available without a prescription. Label information for Lunesta and generic eszopiclone products will be changed to the new recommended starting dose. In the meantime, if you take these drugs, do so with caution, and only in the smallest dose.

If you have a bad reaction, report it to MedWatch, the FDA’s safety information and adverse event reporting program. You can call in the problem at (800) 332-1088, fax it to (800) 332 -0178 or link here to report it online.

To learn more about sleep problems and how to address them safely, read our newsletter, “The Struggle to Sleep.”

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