Key Identifying Information
- Rozerem is manufactured by Takeda Pharmaceutical Company Limited, Osaka, Japan 1
- It is available as an 8 mg tablet formulation 2
- The medication should be taken approximately 30 minutes prior to bedtime 2
Distinguishing Regulatory Features
- Ramelteon/Rozerem is the first melatonin receptor agonist approved by the FDA for insomnia treatment 2, 4
- It is notably NOT classified as a DEA-controlled substance, making it unique among prescription sleep medications 2, 5
- The FDA approval contains no limitation on duration of prescription, though clinical guidelines recommend regular reassessment 2
Mechanism Distinguishing It From Other Sleep Medications
- Ramelteon acts as a selective MT₁/MT₂ melatonin receptor agonist rather than through GABA-ergic sedation like traditional hypnotics 1, 6
- It functions as a "chronohypnotic" working on the suprachiasmatic nucleus (the body's master clock) rather than producing direct sedation 1, 2
- This represents the first new therapeutic mechanism for prescription insomnia medication in over three decades 1