![]() ![]() The recommended starting dose of Lunesta has been lowered to 1 mg from 2 mg.Lunesta (eszopiclone) can cause next-day impairment of driving and other activities that require full alertness.Report any side effects from Lunesta or other medicines to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of this page.Īdditional Information for Health Care Professionals.Talk to your health care professional if you have any questions or concerns about Lunesta or other insomnia medicines.Over-the-counter (OTC) insomnia medicines that are available without a prescription should not be considered safer than prescription insomnia medicines for next-morning alertness and driving.Take all insomnia medicines exactly as prescribed. ![]() Read the patient Medication Guide that comes with your Lunesta prescription.Patients taking a 3 mg dose of Lunesta are cautioned against driving or engaging in other activities that are hazardous or require complete mental alertness the day after use.Each patient and situation is unique, and the appropriate dose should be discussed with your health care professional. If you are currently taking Lunesta, continue taking your prescribed dose and contact your health care professional to ask about the most appropriate dose for you.Elderly patients and patients with severe liver disease should not take doses of more than 2 mg.The 1 mg dose can be increased to 2 mg or 3 mg if needed, but the higher doses are more likely to impair next-day driving and other activities that require full alertness. The recommended starting dose of Lunesta has been lowered to 1 mg from 2 mg, to be taken once each evening immediately before bedtime.Lunesta can cause next-day impairment of driving and other activities that require full alertness.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.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. 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. The drug labels for generic eszopiclone products will also be updated to include these changes. We have approved changes to the Lunesta prescribing information and the patient Medication Guide to include these new recommendations. We caution patients taking a 3 mg dose against driving or engaging in other activities that require complete mental alertness the day after use. 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. Women and men are equally susceptible to impairment from Lunesta, so the recommended starting dose of 1 mg is the same for both. The new lower recommended starting dose of 1 mg at bedtime will result in less drug in the blood the next day. Despite these driving and other problems, patients were often unaware they were impaired. Patients should continue taking their prescribed dose of Lunesta and contact their health care professionals to ask about the most appropriate dose for them.Ī 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). Health care professionals should follow the new dosing recommendations when starting patients on Lunesta. As a result, we have decreased the recommended starting dose of Lunesta to 1 mg at bedtime. 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. ![]()
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