Friday, May 30, 2014

FDA Recommends Lower Starting Dose for Popular Sleep Medication

The Food and Drug Administration
(FDA) has announced that it is recommending that health care professionals who prescribe the sleep medication eszopliclone (marketed as Lunesta) lower the current recommended starting dose due to risk of impairment the morning after use of the sleeping aid. The recommended starting dose has been decreased from 2 milligrams to 1 milligram.

The dose change is based in part on findings from a study of nearly 100 healthy volunteers, aged 25 to 40, who were given 3 milligrams of eszopliclone or placebo. The data showed that administration of 3 milligrams of eszoplicone was associated with severe next-morning memory and psychomotor impairment—which included driving skills—in both men and women up to 11 hours after taking the drug. According to the study, despite the long-lasting effects, patients were often unaware that they were impaired.

The FDA recommends that patients currently taking 2 milligram or 3 milligram doses of eszoplicone contact their physician to ask for instructions on how to continue to take their medicine safely at a dose that is best for them.

“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,” commented Ellis Unger, M.D., director of the Office of Drug Evaluation I at the FDA. “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.”

To read the FDA Safety Communication click here. To read more about sleep disorders, see the Psychiatric News articles, "Eating, Sleep Disorder Criteria Revised in DSM-5" and "Combining Insomnia, Depression Treatment May Improve Outcome."


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