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These highlights do not include all the information needed to use ROZEREM safely and effectively. See full prescribing information for ROZEREM. ROZEREM (ramelteon) tablets Initial U.S. Approval: 2005
Medication labelWhy this: Advisory · dailymed-prescription
ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency were performed after 2 days of treatment during the crossover study (elderly only), at 5 weeks in the 6-week studies (adults and elderly), and at the end of the 6-month study (adults and elderly) [see Clinical Studies (14)].
- generic_name
- ramelteon
- product_names
- ramelteon
- ndc
- 68151-4881, 64764-805, 68151-4881-1
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en