FDA Issues New Safety Announcement: Next-Day Impairment with Sleep Aid Lunesta®
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.
A recent study of Lunesta® found that the previously recommended dose of 3mg can cause impairment to driving skills and other activities that require alertness, such as memory and coordination. As a result, the FDA has decreased the recommended starting dose of Lunesta® to 1 mg at bedtime for both men and women. The FDA stated in its Safety Announcement: “Women and men are equally susceptible to impairment from Lunesta, so the recommended starting dose of 1 mg is the same for both. 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. We caution patients taking a 3 mg dose against driving or engaging in other activities that require complete mental alertness the day after use.”
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.
The choice of a lawyer is an important decision and should not be based solely on advertisements.