Safety Alerts & Recalls
What does this mean?
Drowsiness is listed as a common side effect for all insomnia medicines, along with warnings that people may still feel drowsy the next day after taking one of these products. If you take Lunesta (eszopiclone) or other medicines to help you sleep, please be aware that you can experience decreased mental alertness the morning after use, even if you feel fully awake. 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.
Please continue to take your Lunesta or your generic product containing eszopiclone at your prescribed dose. However, you should contact your healthcare provider to ask about the most appropriate dose for you. It is especially important to follow up with your doctor if you are currently taking a dose of 2 mg or 3 mg, if you are elderly, or if you have liver problems, as these factors may increase your risk of next-day impairment and other side effects. Each patient and situation is unique, and the appropriate dose should be discussed with your healthcare provider.
This alert is also a good reminder to review your insomnia treatment with your doctor periodically to make sure the benefits continue to outweigh the risk of side effects and to ask about techniques that you might be able to use to improve your sleeping habits.
Be sure to read the patient Medication Guide that comes with your Lunesta or eszopiclone prescription and talk to your healthcare provider if you have any questions or concerns about your insomnia medicine.
Patients and healthcare providers are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:
--- Telephone: 1-800-332-1088
--- Fax: 1-800-332-0178
--- Mail: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
--- Website: www.fda.gov/safety/medwatch
FDA Requires Lower Starting Dose of Lunesta (eszopiclone) to Reduce Risk of Next-Day Impairment
The U.S. Food and Drug Administration (FDA) is warning that Lunesta (eszopiclone), a medicine used to help with sleeping, can cause next-day impairment of driving and other activities that require alertness. As a result, the FDA has required the manufacturer of Lunesta and generic eszopiclone products to update the prescribing information (also known as the drug label) and the patient Medication Guide to include a lower recommended starting dose. The recommended starting dose of Lunesta has been decreased from 2 milligrams (mg) to 1 mg at bedtime 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 a lower dose means less eszopiclone will remain in the body in the morning hours.
The dose change is based on a recent study that showed, compared with an inactive pill (placebo), Lunesta 3 mg was associated with severe next-morning impairment of driving skills, memory, and coordination in both men and women 7.5 hours after taking the medicine. The study found that the 3 mg dose can cause impairment as long as 11 hours after the medicine is taken. Patients were often unaware they were impaired.
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