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Rozerem (Ramelteon)
Rozerem (Ramelteon) is a melatonin receptor agonist that binds to melatonin receptors MT1 and MT2, mimicking the action of melatonin to regulate sleep-wake cycles.
Rozerem (Ramelteon) is a melatonin receptor agonist that binds to melatonin receptors MT1 and MT2, mimicking the action of melatonin to regulate sleep-wake cycles. Used for Insomnia characterized by difficulties with sleep initiation.
At a glance
| Generic name | Rozerem (Ramelteon) |
|---|---|
| Also known as | Ramelteon, Rozerem, ramelteon |
| Sponsor | Southern California Institute for Research and Education |
| Drug class | Melatonin receptor agonist |
| Target | MT1 and MT2 |
| Modality | Small molecule |
| Therapeutic area | Sleep disorders |
| Phase | Phase 3 |
Mechanism of action
By activating melatonin receptors, Ramelteon helps to increase the levels of melatonin in the brain, promoting sleepiness and reducing wakefulness. This action is thought to be mediated through the MT1 and MT2 receptors, which are involved in regulating the sleep-wake cycle. Activation of these receptors leads to a decrease in the activity of neurons that promote wakefulness and an increase in the activity of neurons that promote sleepiness.
Approved indications
- Insomnia characterized by difficulties with sleep initiation
Common side effects
- Headache
- Dizziness
- Nausea
- Somnolence
Key clinical trials
- Melatonin Agonist for Shift-time Workers. (PHASE4)
- Comparative Pharmacokinetic Study of Ramelteon Modified-Release Tablets and Ramelteon Tablets in Healthy Subjects (PHASE1)
- The Study of Combination Use of Melatonin Receptor Agonist for Dose Reduction or Interruptions of Benzodiazepine (BZD) and Non-BZD Hypnotics on Chronic Insomnia (PHASE4)
- Delirium Reduction With Ramelteon (PHASE4)
- A Study of Ramelteon in Chinese Patients With Chronic Insomnia (PHASE3)
- The Effect of Ramelteon on Delirium and Sleep in Patients Admitted to the ICU (PHASE4)
- Efficacy and Tolerability of Ramelteon in Patients With Rapid Eye Movement (REM) Behavior Disorder and Parkinsonism (NA)
- Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Rozerem (Ramelteon) CI brief — competitive landscape report
- Rozerem (Ramelteon) updates RSS · CI watch RSS
- Southern California Institute for Research and Education portfolio CI