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ClinicalTrials.gov public records Last synced Sep 11, 2026, 10:39 AM EDT

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Showing 1–24 of 40 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Ramelteon 8 mg Clear all
Completed Phase 3 Interventional

Study of Efficacy of Ramelteon in Adults With Chronic Insomnia

NCT00671125
View directory record Official record
Conditions
Chronic Insomnia
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years to 64 Years
Enrollment
405 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003
U.S. locations
25
States / cities
Birmingham, Alabama • Scottsdale, Arizona • Hot Springs, Arkansas + 22 more
Source: ClinicalTrials.gov public record
Updated Nov 11, 2012 · Synced Sep 11, 2026, 10:39 AM EDT
Completed Phase 2 Interventional Results available

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

NCT00593736
View directory record Official record
Conditions
Sleep Disorders, Circadian Rhythm
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years and older
Enrollment
132 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2008
U.S. locations
42
States / cities
Birmingham, Alabama • Tucson, Arizona • Hot Springs, Arkansas + 39 more
Source: ClinicalTrials.gov public record
Updated Feb 27, 2012 · Synced Sep 11, 2026, 10:39 AM EDT
Completed Phase 3 Interventional

Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia.

NCT00671294
View directory record Official record
Conditions
Chronic Insomnia
Interventions
Ramelteon and Placebo (9 possible combinations total)
Drug
Lead sponsor
Takeda
Industry
Eligibility
65 Years and older
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2002 – 2003
U.S. locations
18
States / cities
Hot Springs, Arkansas • Irvine, California • Palm Springs, California + 15 more
Source: ClinicalTrials.gov public record
Updated Feb 27, 2012 · Synced Sep 11, 2026, 10:39 AM EDT
Not listed Phase 4 Interventional

Delirium Reduction With Ramelteon

NCT05069428
View directory record Official record
Conditions
Delirium
Interventions
Ramelteon 8mg
Drug
Lead sponsor
Centennial Medical Center
Other
Eligibility
18 Years and older
Enrollment
506 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Aug 21, 2024 · Synced Sep 11, 2026, 10:39 AM EDT
Completed Phase 3 Interventional Results available

Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)

NCT01048242
View directory record Official record
Conditions
Insomnia, Obstructive Sleep Apnea
Interventions
rozerem, Placebo
Drug
Lead sponsor
University of Pennsylvania
Other
Eligibility
60 Years and older
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2009
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated May 24, 2023 · Synced Sep 11, 2026, 10:39 AM EDT
Terminated Phase 4 Interventional

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

NCT00462254
View directory record Official record
Conditions
Parkinson's Disease
Interventions
ROZEREM, Ramelteon
Drug
Lead sponsor
Southern California Institute for Research and Education
Other
Eligibility
45 Years to 85 Years
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2008
U.S. locations
1
States / cities
Long Beach, California
Source: ClinicalTrials.gov public record
Updated Nov 10, 2010 · Synced Sep 11, 2026, 10:39 AM EDT
Terminated Not applicable Interventional Results available

Efficacy and Tolerability of Ramelteon in Patients With Rapid Eye Movement (REM) Behavior Disorder and Parkinsonism

NCT00745030
View directory record Official record
Conditions
REM Behavior Disorder, Parkinsonism
Interventions
Rozerem, Placebo
Drug
Lead sponsor
Northwestern University
Other
Eligibility
Not listed
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Jan 8, 2024 · Synced Sep 11, 2026, 10:39 AM EDT
Completed Phase 4 Interventional Accepts healthy volunteers Results available

Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

NCT00507546
View directory record Official record
Conditions
Insomnia, Spinal Cord Injury, Tetraplegia, Sleep Disorders
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
US Department of Veterans Affairs
Federal
Eligibility
18 Years to 65 Years
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2007 – 2011
U.S. locations
1
States / cities
Palo Alto, California
Source: ClinicalTrials.gov public record
Updated May 21, 2014 · Synced Sep 11, 2026, 10:39 AM EDT
Completed Phase 2 Interventional Results available

Ramelteon in the Prevention of Post-operative Delirium

NCT02324153
View directory record Official record
Conditions
Delirium, Delirium, Dementia, Amnestic, Cognitive Disorders, Delayed Emergence From Anesthesia, Cognitive Disorders
Interventions
Ramelteon, Microcrystalline Cellulose, Riboflavin 100 mg
Drug
Lead sponsor
Johns Hopkins University
Other
Eligibility
65 Years and older
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Jun 29, 2020 · Synced Sep 11, 2026, 10:39 AM EDT
Completed Phase 4 Interventional Results available

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

NCT00502320
View directory record Official record
Conditions
Seasonal Affective Disorder
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
Lehigh Valley Hospital
Other
Eligibility
18 Years to 65 Years
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2008
U.S. locations
1
States / cities
Allentown, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Oct 5, 2009 · Synced Sep 11, 2026, 10:39 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

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

NCT00914862
View directory record Official record
Conditions
Insomnia
Interventions
Ramelteon
Drug
Lead sponsor
Takeda
Industry
Eligibility
6 Years to 50 Years
Enrollment
56 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009 – 2011
U.S. locations
2
States / cities
Overland Park, Kansas • Kalamazoo, Michigan
Source: ClinicalTrials.gov public record
Updated Apr 3, 2012 · Synced Sep 11, 2026, 10:39 AM EDT
Completed Phase 4 Interventional Results available

Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

NCT00622427
View directory record Official record
Conditions
ADHD With Sleep Onset Insomnia
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
19 Years to 65 Years
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated May 23, 2013 · Synced Sep 11, 2026, 10:39 AM EDT
Not listed Phase 3 Interventional

Effect of Rozerem on the Perception of GERD Symptoms in Patients With Chronic Insomnia.

NCT01128582
View directory record Official record
Conditions
Gastroesophageal Reflux Disease, Chronic Insomnia
Interventions
Rozerem (ramelteon), placebo
Drug
Lead sponsor
Southern Arizona VA Health Care System
Federal
Eligibility
Up to 82 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
1
States / cities
Tucson, Arizona
Source: ClinicalTrials.gov public record
Updated May 11, 2011 · Synced Sep 11, 2026, 10:39 AM EDT
Terminated Phase 4 Interventional Accepts healthy volunteers

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

NCT00391755
View directory record Official record
Conditions
Migraine Headache
Interventions
ramelteon
Drug
Lead sponsor
Charlottesville Neuroscience
Other
Eligibility
18 Years to 65 Years
Enrollment
4 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2006 – 2009
U.S. locations
1
States / cities
Charlottesville, Virginia
Source: ClinicalTrials.gov public record
Updated Feb 9, 2012 · Synced Sep 11, 2026, 10:39 AM EDT
Terminated Phase 2 Interventional Results available

A Study of a Melatonin Receptor Agonist to Prevent Migraine

NCT00739024
View directory record Official record
Conditions
Migraine, Migraine With Aura, Migraine Without Aura
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
Swedish Medical Center
Other
Eligibility
18 Years to 65 Years
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
1
States / cities
Seattle, Washington
Source: ClinicalTrials.gov public record
Updated Aug 22, 2012 · Synced Sep 11, 2026, 10:39 AM EDT
Completed Phase 4 Interventional Results available

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

NCT00552760
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
Lehigh Valley Hospital
Other
Eligibility
18 Years to 65 Years
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2010
U.S. locations
1
States / cities
Allentown, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Apr 13, 2014 · Synced Sep 11, 2026, 10:39 AM EDT
Completed Phase 3 Interventional

Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia

NCT00671255
View directory record Official record
Conditions
Chronic Insomnia
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
65 Years and older
Enrollment
829 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2002 – 2004
U.S. locations
102
States / cities
Columbiana, Alabama • Mobile, Alabama • Muscle Shoals, Alabama + 99 more
Source: ClinicalTrials.gov public record
Updated Feb 27, 2012 · Synced Sep 11, 2026, 10:39 AM EDT
Not yet recruiting Phase 4 Interventional

Doxepin Alone or Combined With Ramelteon Versus Placebo for Improving Sleep Quality After Primary Total Knee Arthroplasty

NCT07598734
View directory record Official record
Conditions
Sleep Quality Post-TKA, Postoperative Knee Function, Quality of Life After Primary TKA
Interventions
Doxepin 6 mg, Ramelteon 8 mg, Placebo Tablets
Drug
Lead sponsor
University of Washington
Other
Eligibility
18 Years to 80 Years
Enrollment
129 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
1
States / cities
Seattle, Washington
Source: ClinicalTrials.gov public record
Updated May 19, 2026 · Synced Sep 11, 2026, 10:39 AM EDT
Completed Phase 4 Interventional Results available

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

NCT00492232
View directory record Official record
Conditions
Chronic Insomnia
Interventions
Ramelteon and zolpidem, Placebo and zolpidem
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years and older
Enrollment
135 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2008
U.S. locations
41
States / cities
Hot Springs, Arkansas • Anaheim, California • Fountain Valley, California + 38 more
Source: ClinicalTrials.gov public record
Updated Jul 19, 2010 · Synced Sep 11, 2026, 10:39 AM EDT
Completed Phase 4 Interventional

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

NCT01401413
View directory record Official record
Conditions
REM Sleep Behavior Disorder
Interventions
ramelteon, placebo
Drug
Lead sponsor
Sleep Medicine Centers of WNY
Other
Eligibility
18 Years to 80 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
1
States / cities
West Seneca, New York
Source: ClinicalTrials.gov public record
Updated Jul 24, 2011 · Synced Sep 11, 2026, 10:39 AM EDT
Terminated Phase 3 Interventional

Efficacy of Ramelteon in Adults With Chronic Insomnia

NCT00672724
View directory record Official record
Conditions
Chronic Insomnia
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years to 64 Years
Enrollment
1,081 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005
U.S. locations
43
States / cities
Mesa, Arizona • Phoenix, Arizona • Scottsdale, Arizona + 40 more
Source: ClinicalTrials.gov public record
Updated Feb 27, 2012 · Synced Sep 11, 2026, 10:39 AM EDT
Withdrawn Phase 4 Interventional

Ramelteon and Citicoline for Delirium

NCT02840591
View directory record Official record
Conditions
Delirium
Interventions
Ramelteon, Citicoline
Drug
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Nov 8, 2017 · Synced Sep 11, 2026, 10:39 AM EDT
Terminated Phase 3 Interventional Results available

Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon

NCT00642694
View directory record Official record
Conditions
Major Depressive Disorder, Insomnia
Interventions
Escitalopram, Ramelteon, Placebo
Drug · Other
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
18 Years to 70 Years
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2010
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Jul 25, 2019 · Synced Sep 11, 2026, 10:39 AM EDT
Completed Phase 3 Interventional Accepts healthy volunteers

Efficacy of Ramelteon on Transient Insomnia in Healthy Adults

NCT00671398
View directory record Official record
Conditions
Transient Insomnia
Interventions
Ramelteon, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years to 64 Years
Enrollment
289 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2002 – 2003
U.S. locations
12
States / cities
Palm Springs, California • San Diego, California • Miami, Florida + 9 more
Source: ClinicalTrials.gov public record
Updated Feb 27, 2012 · Synced Sep 11, 2026, 10:39 AM EDT