FDA Mandates Change to Lunesta Starting Dose

The FDA has announced that the manufacturer of Lunesta (eszopiclone; Sunovion) will be required to change the drug label and patient Medication Guide and lower the current recommended starting dose. The change in dosing will apply to both Lunesta and generic eszopiclone products.

The recommended starting dose of Lunesta has been decreased from 2mg to 1mg for men and women. If needed, the 1mg dose can be increased to 2mg or 3mg, but the FDA warns that higher doses could lead to next-day impairment of activities requiring alertness such as driving. Eszopiclone is currently indicated for treatment of insomnia in adults ≥18 years of age.

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This decision is based on research that shows eszopiclone levels in some patients after waking may be high enough to impair activities requiring alertness, even if the patient feels fully awake. A study of 91 healthy adults ages 25–40 found that Lunesta 3mg was associated with severe next-morning psychomotor and memory impairment 7.5 hours after taking the drug in both men and women. Recommended doses can also cause impairment to driving skills, memory, and coordination for up to 11 hours after the drug is taken, the study data also showed. Many patients were unaware that they were impaired during this time.

Patients that are currently taking the 2mg or 3mg doses of eszopiclone are advised to contact their healthcare professional regarding safety and proper dosing.

For more information visit FDA.gov.