ROZEREM (ramelteon)
Rozerem is a sleep medication used for adults and elderly patients who have difficulty falling asleep. It helps patients with insomnia specifically characterized by a long sleep onset time. This medication is prescribed to support the sleep-wake cycle and has been studied for use ranging from a few days up to six months.
How ROZEREM Works
Rozerem works by binding to melatonin MT1 and MT2 receptors, which are responsible for maintaining the circadian rhythm and the normal sleep-wake cycle. Unlike many other sleep aids, it does not interact with GABA receptors or other neurotransmitter systems like serotonin and dopamine. The drug also produces an active metabolite that circulates at high concentrations to further support its sleep-promoting properties.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2005-07-22
- Routes
- ORAL
- Dosage Forms
- TABLET
ROZEREM Approval History
What ROZEREM Treats
1 indicationsROZEREM is approved for 1 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Insomnia
ROZEREM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ROZEREM
3 of 17FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07382843 | C202205038 | Ph 4 | completed | Melatonin Agonist for Shift-time Workers. |
| NCT06512363 | LMTAP2022-III | Ph 3 | not yet recruiting | A Study of Ramelteon in Chinese Patients With Chronic Insomnia |
| NCT03931070 | 1364075 | Ph 4 | completed | The Effect of Ramelteon on Delirium and Sleep in Patients Admitted to the ICU |
| NCT03265951 DORMI | RF-1070471 | Ph 4 | withdrawn | Ramelteon for Complex Insomnia in Veterans With PTSD |
| NCT02324153 RECOVER results posted | IRB00097232 1R21AG050850-01A1 | Ph 2 | completed | Ramelteon in the Prevention of Post-operative Delirium |
| NCT03165695 | 2017P000656 | Ph 4 | withdrawn | Ramelteon vs Placebo for Prevention of Delirium and Improvement of Sleep in Hospitalized Older Adults |
| NCT02560324 RAP results posted | 823286 R21DA040902 | Ph 2 | completed | Effect of Ramelteon on Smoking Abstinence |
| NCT02669082 results posted | Ramelteon-4002 JapicCTI-163143, U1111-1177-4116 | Ph 4 | completed | The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy |
| NCT02840591 | 042016-063 | Ph 4 | withdrawn | Ramelteon and Citicoline for Delirium |
| NCT00539110 Sleep3 results posted | 09-04-07-01 | Ph 2 | completed | Differential Effects of Zolpidem Versus Ramelteon in Burned Children |
| NCT01677182 results posted | TAK-375SL_301 2012-001357-10, U1111-1129-5184 | Ph 3 | terminated | Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolar 1 Disorder |
| NCT00893269 | NA_00017909 R21DA025794 | Ph 1 | completed | The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep |
| NCT00622427 results posted | F071204001 | Ph 4 | completed | Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia |
| NCT00869167 results posted | 07-052R | Ph 3 | terminated | Ramelteon for Insomnia Comorbid With Asthma |
| NCT00595504 results posted | 2007P-001929 FWA00003136 | Ph 4 | completed | Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia |
| NCT00739024 results posted | CRC 0690 | Ph 2 | terminated | A Study of a Melatonin Receptor Agonist to Prevent Migraine |
| NCT00914862 results posted | TAK-375_110 U1111-1112-5188 | Ph 1 | completed | Pharmacokinetic and Safety of Ramelteon Between Adolescents With Insomnia and Healthy Adults |
| NCT01401413 | NEU1640207B | Ph 4 | completed | Study to Determine Whether Ramelteon Helps People With REM Sleep Behavior Disorder |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ROZEREM FDA Label Details
Indications & Usage
FDA Label (PDF)ROZEREM is indicated for the treatment of Insomnia.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment