Last reviewed · How we verify
Rozerem
At a glance
| Generic name | Rozerem |
|---|---|
| Also known as | Ramelteon, TAK-375 |
| Sponsor | Northwestern University |
| Target | Melatonin receptor type 1A, Melatonin receptor type 1B |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
Approved indications
- Initial insomnia
Common side effects
- Dizziness
- Somnolence
- Fatigue
- Nausea
- Insomnia exacerbated
Serious adverse events
- Severe anaphylactic and anaphylactoid reactions
- Abnormal thinking, behavior changes, and complex behaviors
- CNS effects
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 CI brief — competitive landscape report
- Rozerem updates RSS · CI watch RSS
- Northwestern University portfolio CI