FDA Requires Sunovion Pharma To Lower Lunesta Dose
By Cyndi Root
The Food and Drug Administration (FDA) announced in a press release that it required Sunovion Pharmaceuticals, a U.S. subsidiary of Dainippon Sumitomo Pharma, to lower the current recommended starting dose of Lunesta (eszopiclone). The federal agency says that it will change the drug label of the sleep drug due to the risk of impairment the morning after using the drug.
Ellis Unger, director of the Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research said, “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.”
Lunesta
Lunesta (eszopiclone) is a sleep aid approved to help patients fall asleep and stay asleep. A blockbuster drug, physicians have written over 30 million prescriptions for the medication. Currently, the beginning dose is 2 mg for adult men and women. The FDA is reducing the beginning dose to 1 mg. Physicians and patients can agree to raise the dosage to 2 or 3 mg, but higher doses lead to morning impairment. Residual drug concentration in the body can impair mental alertness while carrying out important activities, such as driving.
FDA Action
The FDA changed the dose, in part, because of a clinical study. Ninety-one healthy adults ages 25 to 40 took part comparing Lunesta to a placebo. The participants taking 3 mg of Lunesta at bedtime had severe impairment the following morning. People experienced psychomotor, memory, and driving skill impairment. Of note, patients were unaware of the impairment that lasted 7.5 to 11 hours after taking the drug.
The federal agency is changing the prescribing information (label) and the patient Medication Guide to reflect the dosage change. Physicians are asked to inform patients of the new beginning dose and to educate patients about the risks of impairment after taking any sleep drug, even if they do not feel drowsy.
This new action comes on the heels of last year’s FDA dosage lowering of popular sleep drugs like Ambien and Ambien CR, with the active ingredient zolpidem. The FDA indicated that it will continue to monitor sleep drugs, evaluate morning-after impairment, and will update health professionals and the public as needed.