MedPath

Ramelteon

Generic Name
Ramelteon
Brand Names
Rozerem
Drug Type
Small Molecule
Chemical Formula
C16H21NO2
CAS Number
196597-26-9
Unique Ingredient Identifier
901AS54I69
Background

Ramelteon is the first in a new class of sleep agents that selectively binds to the melatonin receptors in the suprachiasmatic nucleus (SCN). It is used for insomnia, particularly delayed sleep onset. Ramelteon has not been shown to produce dependence and has shown no potential for abuse.

Indication

用于失眠症，特别适用于治疗难以入睡型失眠症。

Associated Conditions
Insomnia
Clinical Trials
Related News

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

Phase 3
Terminated
Conditions
Bipolar Disorder
Interventions
Drug: Placebo
First Posted Date
2011-11-09
Last Posted Date
2016-05-16
Lead Sponsor
Takeda
Target Recruit Count
642
Registration Number
NCT01467713

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

Phase 3
Terminated
Conditions
Acute Depressive Episode
Interventions
Drug: Placebo
First Posted Date
2011-11-09
Last Posted Date
2016-05-16
Lead Sponsor
Takeda
Target Recruit Count
490
Registration Number
NCT01467700

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

Phase 4
Completed
Conditions
REM Sleep Behavior Disorder
Interventions
Drug: placebo
First Posted Date
2011-07-25
Last Posted Date
2011-07-25
Lead Sponsor
Sleep Medicine Centers of WNY
Target Recruit Count
20
Registration Number
NCT01401413
Locations
🇺🇸

Sleep Medicine Centers of WNY, West Seneca, New York, United States

Effect of Rozerem on Sleep Among People With Traumatic Brain Injury

Phase 4
Conditions
Brain Injury
Insomnia
Interventions
Dietary Supplement: Placebo
First Posted Date
2010-09-22
Last Posted Date
2014-09-09
Lead Sponsor
Kessler Foundation
Target Recruit Count
20
Registration Number
NCT01207050
Locations
🇺🇸

Kessler Foundation Research Center, West Orange, New Jersey, United States

Effects of Ramelteon (8mg) Alone and in Combination With Multi-Component Behavioral Therapy on Sleep and Circadian Phase in Patients With Chronic Insomnia

Phase 4
Conditions
Insomnia
Interventions
Drug: Placebo
Other: Rozerem 8mg in combination with Multi Component Behavior Therapy
First Posted Date
2010-08-12
Last Posted Date
2010-08-12
Lead Sponsor
University of Arizona
Target Recruit Count
30
Registration Number
NCT01180855
Locations
🇺🇸

University of Arizona Sleep Research Laboratory, Tucson, Arizona, United States

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

Phase 3
Conditions
Gastroesophageal Reflux Disease
Chronic Insomnia
Interventions
Drug: placebo
First Posted Date
2010-05-24
Last Posted Date
2011-05-12
Lead Sponsor
Southern Arizona VA Health Care System
Target Recruit Count
40
Registration Number
NCT01128582
Locations
🇺🇸

Southern Arizona Veterans Health Care System, Tucson, Arizona, United States

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

Phase 3
Completed
Conditions
Obstructive Sleep Apnea
Insomnia
Interventions
Drug: Placebo
First Posted Date
2010-01-13
Last Posted Date
2023-05-25
Lead Sponsor
University of Pennsylvania
Target Recruit Count
27
Registration Number
NCT01048242
Locations
🇺🇸

University of Pennsylvania, Philadelphia, Pennsylvania, United States

Efficacy and Safety of Ramelteon on Chronic Insomnia

Phase 2
Completed
Conditions
Chronic Insomnia
Interventions
First Posted Date
2009-06-05
Last Posted Date
2010-06-02
Lead Sponsor
Takeda
Target Recruit Count
66
Registration Number
NCT00915135

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

Phase 1
Completed
Conditions
Insomnia
Interventions
First Posted Date
2009-06-05
Last Posted Date
2012-04-04
Lead Sponsor
Takeda
Target Recruit Count
56
Registration Number
NCT00914862

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

Not Applicable
Withdrawn
Conditions
Huntington's Disease
Parkinson's Disease
Dementia With Lewy Bodies
Sleep Disorders
Circadian Dysregulation
Interventions
Drug: Placebo
First Posted Date
2009-05-22
Last Posted Date
2012-11-06
Lead Sponsor
Massachusetts General Hospital
Registration Number
NCT00907595
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

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