Lunesta is indicated for the treatment of patients who experience difficulty falling asleep as well as for the treatment of patients who are unable to sleep through the night sleep maintenance difficulty. It should not be used in conjunction with other prescription or nonprescription sleep aids, by pregnant women, or by patients with known psychiatric illness without medical supervision.
Patients taking eszopiclone, or any hypnotic agent, may develop dependence and experience withdrawal symptoms when discontinuing use. The product is available in 1 mg, 2 mg, and 3 mg tablets. The recommended starting dose for Lunesta for most non-elderly adults is 2 mg immediately before bedtime.
Dosing can be initiated at or raised to 3 mg if clinically indicated, since 3 mg is more effective for sleep maintenance. For elderly patients whose primary complaint is difficulty falling asleep is 1 mg immediately before bedtime. In these patients, the dose may be increased to 2 mg if clinically indicated. For elderly patients whose primary complaint is difficulty staying asleep, the recommended dose is 2 mg immediately before bedtime.
FDA approval of Lunesta was based on results from six clinical trials enrolling a total of subjects with chronic and transient insomnia. The FDA's decision to approve Lunesta for the long-term treatment of insomnia was based on a six-month, double-blind, placebo-controlled trial enrolling subjects. The total NDA for Lunesta contained data from a total of 24 clinical trials. The treatment of chronic insomnia was established in five controlled studies. Three controlled studies were in adult subjects, and two controlled studies were in elderly subjects with chronic insomnia.
Adverse events associated with the use of Lunesta may include but are not limited to the following:. Lunesta is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. It is the S-isomer of the marketed non-benzodiazepine rapid-acting hypnotic zopiclone. GABA slows down brain activity so that your mind and body can relax, enabling you to fall asleep and stay sleep. Drug Enforcement Administration, Department of Justice.
Schedules of controlled substances: placement of Zopiclone into schedule IV. Final rule. Fed Regist. Drugs R D. M ; 6 2 Food and Drug Administration FDA is warning that the insomnia drug Lunesta eszopiclone can cause next-day impairment of driving and other activities that require alertness.
As a result, we have decreased the recommended starting dose of Lunesta to 1 mg at bedtime. Health care professionals should follow the new dosing recommendations when starting patients on Lunesta. Patients should continue taking their prescribed dose of Lunesta and contact their health care professionals to ask about the most appropriate dose for them.
A study of Lunesta found that the previously recommended dose of 3 mg can cause impairment to driving skills, memory, and coordination that can last more than 11 hours after receiving an evening dose see Data Summary. Despite these driving and other problems, patients were often unaware they were impaired. The new lower recommended starting dose of 1 mg at bedtime will result in less drug in the blood the next day. 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.
We have approved changes to the Lunesta prescribing information and the patient Medication Guide to include these new recommendations. The drug labels for generic eszopiclone products will also be updated to include these changes. We are continuing to evaluate the risk of impaired mental alertness with the entire class of sleep aid drugs, including over-the-counter drugs available without a prescription, and will update the public as new information becomes available.
Health care professionals and patients can refer to our Sleep Disorder Sedative-Hypnotic Drug Information Web page to find updated information and access the latest labels for insomnia drugs. In a double-blind study of 91 healthy adults between 25 and 40 years old, the effects of Lunesta 3 mg on psychomotor function were assessed the following morning, between 7. Measures included tests of psychomotor coordination that are correlated with the ability to maintain a motor vehicle in the driving lane, tests of working memory, and subjective perception of sedation and coordination.
Compared with placebo, Lunesta 3 mg was associated with next-morning psychomotor and memory impairment that was most severe at 7. Subjective perception of sedation and coordination from Lunesta 3 mg was not consistently different from placebo, even though the subjects were objectively impaired. Lunesta 3 mg had an impairing effect almost as large as zopiclone 7. Zopiclone, which is not approved in the United States, causes consistent psychomotor impairment such that it is often used as a positive control in driving impairment studies.
Facts about eszopiclone A sedative-hypnotic sleep medicine used to treat insomnia in adults Marketed under the brand name Lunesta and also as generics In , there were approximately 3 million prescriptions dispensed and , patients who received a dispensed prescription for Lunesta eszopiclone from U.
Additional Information for Patients Patients who take Lunesta eszopiclone and other medicines to help them sleep can experience decreased mental alertness the morning after use, even if they feel fully awake.
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