On May 15, the U.S. Food and Drug Administration (FDA) issued a Safety Announcement warning that the insomnia drug Lunesta® (eszopiclone) can cause next-day impairment that can last more than 11 hours after receiving an evening dose.
Lunesta® is a sedative-hypnotic sleep medication used to treat insomnia in adults. The active ingredient in Lunesta® is eszopiclone. The FDA reports that there were approximately 3 million prescriptions of Lunesta® dispensed in 2013 and 923,000 patients received a dispensed prescription for Lunesta® (eszopiclone) from U.S. outpatient retail pharmacies.
The FDA is requiring the manufacturer to change the drug label to reflect the new dose recommendation. In its news release, the FDA strongly advises against driving or participating in other activities requiring full mental alertness the day after use if taking more than the new recommended dose, as patients are often unaware they are impaired.