ramelteon
Drug Details
- Generic Name
- ramelteon
- Brand Names
- Rozerem
- Application Number
- NDA021782
- Sponsor
- Takeda Pharmaceuticals America, Inc.
- NDC Codes
- 3
- Dosage Forms
- TABLET, FILM COATED, TABLET
- Routes
- ORAL
- Active Ingredients
- RAMELTEON
Indications and Usage
1 INDICATIONS AND USAGE 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) [see Clinical Studies (14) ]. Ramelteon Tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset.