FDA label
What is ramelteon used for?
The FDA-approved uses of ramelteon, 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: “Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset.”
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Ramelteon, tablet, film coated
Indications and Usage, quoted from the label by Upsher-Smith Laboratories, LLC (ANDA213815). Cross-references to other label sections are left out.
Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset.
The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six month studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies].
Source: DailyMed label, set id 2d22e6ae-2373-4a2f-8dda-d223230c6010, version 4, effective January 8, 2026. NDC 0832-1250, one of 21 listings for this product.
Ramelteon, tablet
Indications and Usage, quoted from the label by Micro Labs Limited (ANDA215243). Cross-references to other label sections are left out.
Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset.
The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly).
Source: DailyMed label, set id 7545c79a-93ea-4f73-beb5-cac46b2ed7e9, version 2, effective April 23, 2025. NDC 42571-375, one of 19 listings for this product.
Questions
What is ramelteon used for?
The FDA label says: “Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset.”
What drug class is ramelteon?
FDA lists ramelteon in the Melatonin Receptor Agonist established pharmacologic class.
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.