Rozerem

(Ramelteon)

ApprovedSmall molecule

Ramelteon is used to treat insomnia, specifically to help people who have difficulty falling asleep at the beginning of the night.[2] Rozerem is currently approved and in use across 23 indications[4].[1]

Rozerem is one of 491 small molecule programs targeting Insulin resistance. It is currently in Approved.

Indications

Total Trials

Active Trials

490

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Insulin ResistanceActive, not recruiting

Nicotine DependenceApproved

Neuropathic PainActive, not recruiting

Migraine Without AuraApproved

Depressive DisorderApproved

Migraine DisorderApproved

Circadian Rhythm Sleep DisorderActive, not recruiting

Brain InjuryUnknown status

DeliriumWithdrawn

Obstructive Sleep ApneaApproved

Insulin ResistanceApproved

Active, not recruiting

Nicotine DependenceApproved

Approved

Neuropathic PainPreclinical

Active, not recruiting

Migraine Without AuraApproved

Approved

Depressive DisorderApproved

Approved

Migraine DisorderApproved

Approved

Circadian Rhythm Sleep DisorderPreclinical

Active, not recruiting

Brain InjuryApproved

Unknown status

DeliriumApproved

Withdrawn

Obstructive Sleep ApneaApproved

Approved

Showing 10 of 22 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Rozerem

Takeda

Approved

1 2

Adenocard

Astellas

Preclinical

2 3

Blenoxane

Bristol-Myers Squibb

Preclinical

1 4

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 5

Spravato

WWim Janssens

Preclinical

2 6

Duragesic

CCephalon

Preclinical

1 7

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 8

Acupan

YYonsei University

Preclinical

1 9

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 10

Rilvegostomig

AstraZeneca

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Not yet recruiting

Insomnia

NCT06512363

Clinical

Trials by Indication[1]

Insomnia23 trials

Ramelteon for Complex Insomnia in Veterans With PTSD

Withdrawn·SState University of New York at Buffalo·Phase 4·NCT03265951

Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty

Completed· Takeda logo

Takeda··NCT02058992·3,339 enrolled

Facilitation of Zolpidem (≥10 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia

Completed· Takeda logo

Takeda·Phase 4·NCT00492232·135 enrolled

Show 20 more trials

Study of Efficacy of Ramelteon in Adults With Chronic Insomnia

Completed· Takeda logo

Takeda·Phase 3·NCT00671125·405 enrolled

Efficacy of Ramelteon in Adults With Chronic Insomnia

Terminated· Takeda logo

Takeda·Phase 3·NCT00672724·1,081 enrolled

Efficacy of Ramelteon on Transient Insomnia in Healthy Adults

Completed· Takeda logo

Takeda·Phase 3·NCT00671398·289 enrolled

Ramelteon in Adults With Chronic Insomnia

Completed· Takeda logo

Takeda·Phase 3·NCT00671567·848 enrolled

Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.

Completed· Takeda logo

Takeda·Phase 3·NCT00247390·451 enrolled

Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia

Completed· Takeda logo

Takeda·Phase 3·NCT00671255·829 enrolled

A Study of Ramelteon in Chinese Patients With Chronic Insomnia

Not yet recruiting·NNanjing Chia-tai Tianqing Pharmaceutical·Phase 3·NCT06512363·280 enrolled

Efficacy of Ramelteon on Insomnia Symptoms Associated With Jet Lag in Healthy Adult Volunteers

Completed· Takeda logo

Takeda·Phase 4·NCT00492011·110 enrolled

Ramelteon 8 mg Tablets Specified Drug-use Survey: <Long-term Survey on Insomnia Accompanied by Difficulty Falling Asleep> - Transitional Survey From the Preceding Drug-use Survey -

Completed· Takeda logo

Takeda··NCT02153086·236 enrolled

The Study of Combination Use of Melatonin Receptor Agonist for Dose Reduction or Interruptions of Benzodiazepine (BZD) and Non-BZD Hypnotics on Chronic Insomnia

Completed·TTranslational Research Center for Medical Innovation, Kobe, Hyogo, Japan·Phase 4·NCT03461042·17 enrolled

Ramelteon for Insomnia Comorbid With Asthma

Terminated·NNorthwestern University·Phase 3·NCT00869167·2 enrolled

Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

Completed·UUniversity of Alabama at Birmingham·Phase 4·NCT00622427·32 enrolled

Long-Term Efficacy of Ramelteon on Endocrine Function in Adult Subjects With Chronic Insomnia

Completed· Takeda logo

Takeda·Phase 3·NCT00656994·122 enrolled

Efficacy of Ramelteon in Subjects With Chronic Insomnia

Completed· Takeda logo

Takeda·Phase 3·NCT00671086·1,213 enrolled

Pharmacokinetic and Safety of Ramelteon Between Adolescents With Insomnia and Healthy Adults

Completed· Takeda logo

Takeda·Phase 1·NCT00914862·56 enrolled

Efficacy and Safety of Ramelteon Combined With Gabapentin in Treating Patients With Insomnia

Completed· Takeda logo

Takeda·Phase 2·NCT00755508·378 enrolled

Safety and Efficacy Study of Ramelteon in Subjects With Chronic Insomnia

Completed· Takeda logo

Takeda·Phase 3·NCT00756002·259 enrolled

Safety and Efficacy of Ramelteon in Adults With Chronic Insomnia

Completed· Takeda logo

Takeda·Phase 3·NCT00237497·275 enrolled

Safety and Efficacy of Ramelteon and Doxepin in Subjects With Chronic Insomnia

Completed· Takeda logo

Takeda·Phase 2·NCT00755495·472 enrolled

A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Demonstrate the Subjective Treatment Effects of Ramelteon on Sleep Using a Post Sleep Questionnaire - Interactive Voice Response System (PSQ-IVRS) in an "At-Home Setting" in an Adult Population With Chronic Insomnia

Completed· Takeda logo

Takeda·Approved·NCT00414102·552 enrolled

Delirium6 trials

Ramelteon vs Placebo for Prevention of Delirium and Improvement of Sleep in Hospitalized Older Adults

Withdrawn·—·Phase 4·NCT03165695

Ramelteon Prevention of Delirium - RCT

Unknown status·HHartford Hospital·Phase 4·NCT02564939·240 enrolled

The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery

Unknown status·UUniversity of California, San Diego·N/A·NCT02691013·120 enrolled

Show 3 more trials

Ramelteon and Citicoline for Delirium

Withdrawn·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT02840591

Delirium Reduction With Ramelteon

Recruiting·—·Phase 4·NCT05069428·506 enrolled

The Effect of Ramelteon on Delirium and Sleep in Patients Admitted to the ICU

Completed·RRhode Island Hospital·Phase 4·NCT03931070·112 enrolled

Bipolar I Disorder3 trials

Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder

Terminated· Takeda logo

Takeda·Phase 3·NCT01467700·490 enrolled

Efficacy and Safety of Ramelteon Sublingual as Adjunctive Therapy for Maintenance Treatment of Bipolar I Disorder

Terminated· Takeda logo

Takeda·Phase 3·NCT01467713·642 enrolled

Add-On Ramelteon in Bipolar I Disorder With Clinically Significant Sleep Disturbance

Terminated·LLindner Center of HOPE·Phase 3·NCT00585208·21 enrolled

Sleep2 trials

Treating Sleep/Wake Cycle Disturbances in Basal Ganglia Disorders With Ramelteon

Withdrawn·MMassachusetts General Hospital·N/A·NCT00907595

Improving Sleep in Nursing Homes

Completed·EEmory University·Phase 4·NCT00576927·79 enrolled

Melatonin2 trials

Melatonin Agonist for Shift-time Workers.

Completed·TTri-Service General Hospital·Phase 4·NCT07382843·61 enrolled

Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

Completed·UUS Department of Veterans Affairs·Phase 4·NCT00507546·12 enrolled

25 more indications

Safety and Efficacy2 trials

Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolar 1 Disorder

Terminated· Takeda logo

Takeda·Phase 3·NCT01677182·535 enrolled

Safety and Efficacy of Ramelteon in Healthy Subjects

Completed· Takeda logo

Takeda·Phase 2·NCT00671190·75 enrolled

Brain Injury1 trial

Effect of Rozerem on Sleep Among People With Traumatic Brain Injury

Unknown status·KKessler Foundation·Phase 4·NCT01207050·20 enrolled

Maintenance Treatment1 trial

A Safety and Efficacy Study of Ramelteon Tablets for Sublingual Administration (TAK-375SL) in the Maintenance Treatment of Bipolar 1 Disorder

Withdrawn· Takeda logo

Takeda·Phase 3·NCT01685151

Parkinson's Disease1 trial

Ramelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson's Disease

Terminated·SSouthern California Institute for Research and Education·Phase 4·NCT00462254·4 enrolled

Treatment1 trial

Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder

Completed·LLehigh Valley Hospital·Phase 4·NCT00502320·50 enrolled

Children1 trial

Differential Effects of Zolpidem Versus Ramelteon in Burned Children

Completed·SShriners Hospitals for Children·Phase 2·NCT00539110·10 enrolled

Medication1 trial

The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep

Completed·JJohns Hopkins University·Phase 1·NCT00893269·36 enrolled

Migraine1 trial

A Study of a Melatonin Receptor Agonist to Prevent Migraine

Terminated·SSwedish Medical Center·Phase 2·NCT00739024·18 enrolled

Breast Cancer1 trial

Treating Chronic Insomnia in Breast Cancer Patients

Terminated·AAccelerated Community Oncology Research Network·Phase 4·NCT00337272·16 enrolled

Headache1 trial

A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches

Terminated·CCharlottesville Neuroscience·Phase 4·NCT00391755·4 enrolled

Depressive Symptoms1 trial

Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon

Terminated·UUniversity of Texas Southwestern Medical Center·Phase 3·NCT00642694·29 enrolled

Neuropathic Pain1 trial

Clinical Management of Neuropathic Pain With Ramelteon

Terminated·MMassachusetts General Hospital·N/A·NCT00753623·23 enrolled

REM sleep behavior disorder1 trial

Study to Determine Whether Ramelteon Helps People With REM Sleep Behavior Disorder

Completed·SSleep Medicine Centers of WNY·Phase 4·NCT01401413·20 enrolled

Insulin resistance1 trial

Mechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation and Insulin Resistance

Completed·—·Phase 4·NCT02156271·75 enrolled

Driving1 trial

Effects of Ramelteon on Driving Ability

Completed·UUtrecht Institute for Pharmaceutical Sciences·Phase 1·NCT00319215·30 enrolled

COVID-191 trial

Melatonin Agonist on Hospitalized Patients With Confirmed or Suspected COVID-19

Unknown status·AAssociação Fundo de Incentivo à Pesquisa·Phase 2·NCT04470297·100 enrolled

Hypertension1 trial

Insomnia Prevalence and Treatment Impact on Systemic Hypertension

Terminated·UUniversity of Sao Paulo·Phase 4·NCT05414864·5 enrolled

Post-Operative Delirium1 trial

Ramelteon in the Prevention of Post-operative Delirium

Completed·JJohns Hopkins University·Phase 2·NCT02324153·80 enrolled

Smoking1 trial

Effect of Ramelteon on Smoking Abstinence

Completed·UUniversity of Pennsylvania·Phase 2·NCT02560324·140 enrolled

Schizophrenia1 trial

Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia

Completed·MMassachusetts General Hospital·Phase 4·NCT00595504·25 enrolled

Bipolar Disorder1 trial

Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder

Completed·LLehigh Valley Hospital·Phase 4·NCT00552760·90 enrolled

Major Depressive Disorder1 trial

The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy

Completed· Takeda logo

Takeda·Phase 4·NCT02669082·26 enrolled

Delayed Sleep Phase Syndrome1 trial

Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome

Completed· Takeda logo

Takeda·Phase 2·NCT00593736·132 enrolled

Mild to Moderate Alzheimer's Disease1 trial

Efficacy and Safety of Ramelteon in Subjects With Mild to Moderate Alzheimer's Disease

Completed· Takeda logo

Takeda·Phase 2·NCT00325728·74 enrolled

Unspecified1 trial

Ramelteon for a Nap Prior to a Night Shift

Completed·—·N/A·NCT00595075·11 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 22, 2005

ROZEREM

NDA NDA021782

Aug 18, 2005

ROZEREM

NDA NDA021782

Oct 20, 2008

ROZEREM

NDA NDA021782

Oct 20, 2008

ROZEREM

NDA NDA021782

Oct 20, 2008

ROZEREM

NDA NDA021782

Nov 9, 2010

ROZEREM

NDA NDA021782

Aug 4, 2011

ROZEREM

NDA NDA021782

Feb 21, 2012

ROZEREM

NDA NDA021782

Mar 1, 2012

ROZEREM

NDA NDA021782

Mar 1, 2012

ROZEREM

NDA NDA021782

Jun 14, 2013

ROZEREM

NDA NDA021782

Jul 13, 2016

ROZEREM

NDA NDA021782

Dec 21, 2018

ROZEREM

NDA NDA021782

Nov 3, 2021

ROZEREM

NDA NDA021782

Sources

References

[1]
ClinicalTrials.gov — 62 trial records for Ramelteon. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Rozerem drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Ramelteon compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Ramelteon. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021782). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Melatonin Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Takeda

Rozerem

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Insomnia23 trials

Delirium6 trials

Bipolar I Disorder3 trials

Sleep2 trials

Melatonin2 trials

Safety and Efficacy2 trials

Brain Injury1 trial

Maintenance Treatment1 trial

Parkinson's Disease1 trial

Treatment1 trial

Children1 trial

Medication1 trial

Migraine1 trial

Breast Cancer1 trial

Headache1 trial

Depressive Symptoms1 trial

Neuropathic Pain1 trial

REM sleep behavior disorder1 trial

Insulin resistance1 trial

Driving1 trial

COVID-191 trial

Hypertension1 trial

Post-Operative Delirium1 trial

Smoking1 trial

Schizophrenia1 trial

Bipolar Disorder1 trial

Major Depressive Disorder1 trial

Delayed Sleep Phase Syndrome1 trial

Mild to Moderate Alzheimer's Disease1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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