Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate ramelteon across active, completed, and terminated protocols. Research primarily focuses on primary sleep disorders—including chronic insomnia, pediatric burn-associated sleep disturbances, and hospital-associated delirium—alongside secondary applications such as tobacco use disorder, comorbid asthma, and acute depressive episodes. Supported by pharmaceutical developers like Takeda, government bodies such as the National Institutes of Health, and academic institutions including Rhode Island Hospital and Northwestern University, these studies encompass both core sleep-promoting indications and broader therapeutic uses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07598734 NOT_YET_RECRUITING
Sleep Quality Post-TKA; Postoperative Knee Function; Quality of Life After Primary TKA
University of Washington
 2026-06 PHASE4
NCT06512363 NOT_YET_RECRUITING
Chronic Insomnia
Nanjing Chia-tai Tianqing Pharmaceutical
 2024-08 PHASE3
NCT07382843 COMPLETED
Circadian Rhythm Disorders
Tri-Service General Hospital (TSGH)
 2024-03-04 PHASE4
NCT05069428 UNKNOWN
Delirium
Centennial Medical Center
 2023-03-26 PHASE4
NCT06890715 COMPLETED
Chronic Insomnia Characterized
Overseas Pharmaceuticals, Ltd.
 2024-06-24 PHASE1
NCT05414864 TERMINATED
Insomnia; Hypertension
University of Sao Paulo
 2022-05-01 PHASE4
NCT03931070 COMPLETED
Delirium
Rhode Island Hospital
 2019-05-09 PHASE4
NCT04470297 UNKNOWN
Covid19; Lung Injury
Associação Fundo de Incentivo à Pesquisa
 2020-09 PHASE2
NCT03165695 WITHDRAWN
Delirium in Old Age
Brigham and Women's Hospital
 2019-12-01 PHASE4
NCT03265951 WITHDRAWN
Insomnia
State University of New York at Buffalo
 2018-01-01 PHASE4
NCT03461042 COMPLETED
Chronic Insomnia
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
 2018-02-06 PHASE4
NCT02324153 COMPLETED
Delirium; Delirium, Dementia, Amnestic, Cognitive Disorders; Delayed Emergence From Anesthesia; Cognitive Disorders
Johns Hopkins University
 2017-03-24 PHASE2
NCT03931070 Completed
Delirium
Rhode Island Hospital
 2019-05-09 Phase 4
NCT02564939 UNKNOWN
Delirium
Hartford Hospital
 2017-02-23 PHASE4
NCT03091738 COMPLETED
Cirrhosis
Virginia Commonwealth University
 2017-02-01 PHASE4
NCT02560324 COMPLETED
Tobacco Use Disorder
University of Pennsylvania
 2015-09 PHASE2
NCT03075657 COMPLETED
Schizophrenia
All India Institute of Medical Sciences, Bhubaneswar
 2017-05-01 PHASE4
NCT02669082 COMPLETED
Insomnia; Major Depressive Disorder
Takeda
 2017-05-09 PHASE4
NCT02691013 UNKNOWN
Delirium; Sleep Deprivation
University of California, San Diego
 2016-02
NCT02840591 WITHDRAWN
Delirium
University of Texas Southwestern Medical Center
 2016-07 PHASE4
NCT01685151 WITHDRAWN
Bipolar Disorder
Takeda
 2012-09 PHASE3
NCT02560324 Completed
Tobacco Use Disorder
University of Pennsylvania|National Institute on Drug Abuse (NIDA)|National Institutes of Health (NIH)
 2015-09 Phase 2
NCT02969343 Completed
Central Line-Associated Bloodstream Infection (CLABSI)|Venous Thromboembolism|Patient Fall|Catheter-Associated Infection|Severe Hypoglycemia|Opioid-Related Severe Adverse Drug Event|Hospital Acquired Pressure Ulcer|Adverse Drug Event|Severe Hospital Acquired Delerium|Rapid Response Related to Arrhythmia
Brigham and Women''s Hospital|Northeastern University
 2015-04 Not Applicable
NCT01467700 TERMINATED
Acute Depressive Episode
Takeda
 2011-12 PHASE3
NCT01467713 TERMINATED
Bipolar Disorder
Takeda
 2011-12 PHASE3
NCT01207050 UNKNOWN
Insomnia; Brain Injury
Kessler Foundation
 2010-09 PHASE4
NCT01677182 TERMINATED
Bipolar Disorder
Takeda
 2012-08 PHASE3
NCT00539110 COMPLETED
Sleep; Burns
Shriners Hospitals for Children
 2009-12 PHASE2
NCT01128582 UNKNOWN
Gastroesophageal Reflux Disease; Chronic Insomnia
Southern Arizona VA Health Care System
 2009-03 PHASE3
NCT00914862 COMPLETED
Insomnia
Takeda
 2009-11 PHASE1
NCT00507546 COMPLETED
Insomnia; Spinal Cord Injury; Tetraplegia; Sleep Disorders
US Department of Veterans Affairs
 2007-07 PHASE4
NCT00753623 TERMINATED
Neuropathic Pain
Massachusetts General Hospital
 2008-09
NCT00893269 COMPLETED
Marijuana Dependence
Johns Hopkins University
 2008-10 PHASE1
NCT01180855 UNKNOWN
Insomnia
University of Arizona
 2007-08 PHASE4
NCT00811746 COMPLETED
Obstructive Sleep Apnea
Southern California Institute for Research and Education
 2008-12
NCT01401413 COMPLETED
REM Sleep Behavior Disorder
Sleep Medicine Centers of WNY
 2008-01 PHASE4
NCT00585208 TERMINATED
Insomnia; Bipolar Disorder
Lindner Center of HOPE
 2007-12 PHASE3
NCT00746239 TERMINATED
Panic Disorder; Insomnia
Milton S. Hershey Medical Center
 2008-08
NCT00642694 TERMINATED
Major Depressive Disorder; Insomnia
University of Texas Southwestern Medical Center
 2007-05 PHASE3
NCT00907595 WITHDRAWN
Huntington's Disease; Parkinson's Disease; Dementia With Lewy Bodies; Sleep Disorders; Circadian Dysregulation
Massachusetts General Hospital
 2009-05
NCT00552760 COMPLETED
Bipolar Disorder
Lehigh Valley Hospital
 2007-11 PHASE4
NCT00595504 COMPLETED
Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorders
Massachusetts General Hospital
 2008-01 PHASE4
NCT00622427 COMPLETED
ADHD With Sleep Onset Insomnia
University of Alabama at Birmingham
 2008-02 PHASE4
NCT00576927 COMPLETED
Sleep Deprivation
Emory University
 2007-10 PHASE4
NCT00745030 TERMINATED
REM Behavior Disorder; Parkinsonism
Northwestern University
 2008-06
NCT00391755 TERMINATED
Migraine Headache
Charlottesville Neuroscience
 2006-10 PHASE4
NCT00869167 TERMINATED
Insomnia; Asthma
Northwestern University
 2008-03 PHASE3
NCT00739024 TERMINATED
Migraine; Migraine With Aura; Migraine Without Aura
Swedish Medical Center
 2008-04 PHASE2
NCT01048242 COMPLETED
Insomnia; Obstructive Sleep Apnea
University of Pennsylvania
 2006-07 PHASE3
NCT00595075 COMPLETED
Healthy
Brigham and Women's Hospital
 2007-12
NCT00337272 TERMINATED
Chronic Insomnia
Accelerated Community Oncology Research Network
 2006-08 PHASE4
NCT02156271 COMPLETED
Insomnia
Duke University
 2007-07 PHASE4
NCT00462254 TERMINATED
Parkinson's Disease
Southern California Institute for Research and Education
 2007-06 PHASE4
NCT00593736 COMPLETED
Sleep Disorders, Circadian Rhythm
Takeda
 2007-10 PHASE2
NCT00502320 COMPLETED
Seasonal Affective Disorder
Lehigh Valley Hospital
 2006-09 PHASE4
NCT00756002 COMPLETED
Sleep Initiation and Maintenance Disorders
Takeda
 2007-08 PHASE3
NCT00492232 COMPLETED
Chronic Insomnia
Takeda
 2007-04 PHASE4
NCT00414102 COMPLETED
Chronic Insomnia
Takeda
 2006-10 PHASE4
NCT00325728 COMPLETED
Chronic Insomnia
Takeda
 2006-03-21 PHASE2
NCT00492011 COMPLETED
Circadian Dysregulation
Takeda
 2007-02 PHASE4
NCT00755495 COMPLETED
Sleep Initiation and Maintenance Disorders
Takeda
 2006-07 PHASE2
NCT00247390 COMPLETED
Chronic Insomnia
Takeda
 2005-07 PHASE3
NCT00316992 COMPLETED
Chronic Obstructive Pulmonary Disease
Takeda
 2006-04 PHASE4
NCT00237497 COMPLETED
Balance
Takeda
 2005-07 PHASE3
NCT00568789 COMPLETED
Insomnia
Takeda
 2006-06 PHASE4
NCT00755508 COMPLETED
Sleep Initiation and Maintenance Disorders
Takeda
 2005-11 PHASE2
NCT00568789 Completed
Insomnia
Takeda
 2006-06 Phase 4
NCT00672724 TERMINATED
Chronic Insomnia
Takeda
 2005-02 PHASE3
NCT00671190 COMPLETED
Sleep Disorder
Takeda
 2005-03 PHASE2
NCT00671086 COMPLETED
Sleep Initiation and Maintenance Disorders
Takeda
 2003-02 PHASE3
NCT00656994 COMPLETED
Insomnia
Takeda
 2003-01 PHASE3
NCT00672802 COMPLETED
Chronic Obstructive Pulmonary Disease; COPD
Takeda
 2003-08 PHASE2
NCT00671255 COMPLETED
Chronic Insomnia
Takeda
 2002-12 PHASE3
NCT00671632 COMPLETED
Drug Abuse
Takeda
 2003-06 PHASE2
NCT00672061 COMPLETED
Sleep Apnea, Obstructive
Takeda
 2003-07 PHASE2
NCT00915135 COMPLETED
Chronic Insomnia
Takeda
 2002-05 PHASE2
NCT00671125 COMPLETED
Chronic Insomnia
Takeda
 2003-01 PHASE3
NCT00671567 COMPLETED
Chronic Insomnia
Takeda
 2002-12 PHASE3
NCT00671294 COMPLETED
Chronic Insomnia
Takeda
 2002-10 PHASE3
NCT00671398 COMPLETED
Transient Insomnia
Takeda
 2002-12 PHASE3
NCT00319215 COMPLETED
Insomnia
Utrecht Institute for Pharmaceutical Sciences
 2006-03 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-05-20)

Check the Ramelteon product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ramelteon acts as a selective agonist that binds with high affinity to human MT1 and MT2 melatonin receptors, activating downstream G-protein-coupled receptor signaling pathways in the suprachiasmatic nucleus of the hypothalamus. By regulating circadian rhythm physiology without modulating GABA receptors or other neurotransmitter systems, this action promotes sleep initiation and restores sleep architecture in clinical conditions such as chronic insomnia and delirium.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.