FDA Cuts Dose Sleep Drug Lunesta Half, Citing Impairment Next Day

People who take Lunesta to help them get to sleep at night may not be alert the following morning. This concern has prompted the Food and Drug Administration (FDA) to halve the recommended dosage for Sunovion’s sleep aid Lunesta (eszopiclone).

The FDA is requiring Sunovion to change the drug label and lower the current recommended starting dose. The FDA's action is based on data showing that eszopiclone levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving, even if they feel fully awake.

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Dose Decreased from 2 Milligrams to 1 Mg

The recommended starting dose of Lunesta 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, said the FDA in a press statement. Using lower doses means less drug will remain in the body in the morning hours.

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Patients in Study Unaware They Were Impaired

The dose change is based, in part, on findings from a study of 91 healthy adults, ages 25 to 40. The study showed that compared to a 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 also 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.

Ellis Unger, M.D., director of the Office of Drug Evaluation in the FDA's Center for Drug Evaluation and Research, said in a press statement,“To help ensure patient safety, healthcare professionals should prescribe, and patients should take, the lowest dose of a sleep medicine that effectively treats their insomnia. 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.”

Experts Weigh In

Commenting on the FDA’s action, Steven Feinsilver, M.D., director of the Center for Sleep Medicine at Mount Sinai Hospital in New York, told Healthline, “Hypnotic medications, or ‘sleeping pills,' have modest effects at best, and are not the answer for most patients with difficulty initiating or maintaining sleep. The point of sleep is to feel refreshed the next day; some medications could produce more sleep time but leave one less awake the next day, which is obviously not worthwhile. Most sleep problems should first be addressed by focusing on sleep behavior. When hypnotics are needed, the lowest dose possible should always be used, as with any medication.”

Janet P. Engle, Pharm.D., FAPhA, head of the Department of Pharmacy Practice at the University of Illinois at Chicago, told Healthline, “If you are currently taking Lunesta 2mg or 3mg, you should continue taking the dose your doctor prescribed, but contact your prescriber to ask about the most appropriate dose for you. You should not change your dose on your own.”

Engle went on to say that it is possible you may experience withdrawal symptoms depending on the amount you are taking and the length of time you have taken it. “In some cases, such as when travel, stress or other disruptions keep you awake, sleeping pills can be helpful and allow a patient to get some much needed rest. However, the most important treatment for insomnia is to determine its underlying cause and treat it.”

Pointing out that she has seen many patients who complain of insomnia who ingest large amounts of caffeine late in the day, Engle advised, “Addressing an issue like that, for example, is as critical as handing out a prescription for a sleeping pill. Keep in mind that sleeping pills are meant to be used for a short period of time. All medications carry risk and sleeping pills are no exception.”

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The FDA Has Taken Action on Sleep Drugs Before

This is the second time that the FDA has taken action related to sleeping aid drugs. In January 2013, the FDA announced a dose reduction for sleep drugs that contain the active ingredient zolpidem, such as Ambien and Ambien CR, because of the risk of next morning impairment.

Patients currently taking the 2 mg and 3 mg doses of Lunesta are advised to 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.

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.

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