FDA label
What is Lunesta used for?
Lunesta contains eszopiclone. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “LUNESTA® (eszopiclone) is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, LUNESTA administered at bedtime decreased sleep latency and improved sleep maintenance.”
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Lunesta, tablet, coated
Indications and Usage, quoted from the label by Waylis Therapeutics LLC (NDA021476). Cross-references to other label sections are left out.
LUNESTA® (eszopiclone) is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, LUNESTA administered at bedtime decreased sleep latency and improved sleep maintenance.
The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).
Source: DailyMed label, set id 3821f4b7-a3c8-4920-ba80-18aa96532c09, version 2, effective January 8, 2025. NDC 80725-010, one of 3 listings for this product.
Questions
What is Lunesta used for?
The FDA label says: “LUNESTA® (eszopiclone) is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, LUNESTA administered at bedtime decreased sleep latency and improved sleep maintenance.”
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.