The dosage change is based, in part, on findings from a study of 91 healthy adults ages 25 to 40. The study shows, compared to an inactive pill (placebo), Lunesta 3 mg was associated with severe next-morning psychomotor and memory impairment in both men and women 7.5 hours after taking the drug. The study found that recommended doses can cause impairment to driving skills, memory, and coordination as long as 11 hours after the drug is taken. Despite these long-lasting effects, patients were often unaware they were impaired.
Taken at bedtime, the recommended starting dose of Lunesta (eszopiclone) has been decreased from 2 milligrams to 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. Using lower doses means less drug will remain in the body in the morning hours.
Patients currently taking the 2 mg and 3 mg doses of Lunesta should contact their health care professional to ask for instructions on how to continue to take their medicine safely at a dose that is best for them.
According
to IMS Health, a health care services company, about 55 million
prescriptions for sleep aids were dispensed in the United States in
2013. Lunesta represents a relatively small part of that market, with
about three million pills prescribed.
It was not the first time the agency has reduced the recommended dose of sleeping pills. In January 2013, the FDA said
that doses of Ambien and other sleeping pills that contain zolpidem
should be halved for women. The agency also told manufacturers that
labels should recommend that health care providers “consider”
prescribing lower doses for men. Drowsiness is listed as a common side effect for all insomnia drugs, along with warnings that people may still feel drowsy the next day after taking one of these products. The FDA is continuing to evaluate the risk of impaired mental alertness with the entire class of sleep drugs, including over-the-counter drugs, and will update the public as new information becomes available.
Studies show that sleepiness can impair driving performance as much or more so than alcohol; the American Automobile Association (AAA) estimates that one out of every six (16.5%) deadly traffic accidents, and one out of eight (12.5%) crashes requiring hospitalization of car drivers or passengers is due to drowsy driving. To learn more about the dangers of poor sleep habits and how you can get a better night's sleep, visit us at the HoustonSleepNet.
Source:
FDA News Release: May 15, 2014
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