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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

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

Not Applicable
Conditions
Sleep Deprivation
Delirium
Interventions
Drug: Placebo
First Posted Date
2016-02-24
Last Posted Date
2022-02-08
Lead Sponsor
University of California, San Diego
Target Recruit Count
120
Registration Number
NCT02691013

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

Phase 4
Completed
Conditions
Major Depressive Disorder
Insomnia
Interventions
First Posted Date
2016-01-29
Last Posted Date
2019-07-22
Lead Sponsor
Takeda
Target Recruit Count
26
Registration Number
NCT02669082
Locations
🇯🇵

Sangenjaya Neurology and Psychosomatic Clinic, Setagaya, Tokyo, Japan

🇯🇵

Himorogi Kokorono Clinic, Shinjuku, Tokyo, Japan

🇯🇵

Ishikawa Mental Clinic, Sapporo, Hokkaido, Japan

and more 4 locations

Ramelteon Prevention of Delirium - RCT

Phase 4
Conditions
Delirium
Interventions
Drug: Placebo
First Posted Date
2015-10-01
Last Posted Date
2018-08-01
Lead Sponsor
Hartford Hospital
Target Recruit Count
240
Registration Number
NCT02564939
Locations
🇺🇸

Hartford Hospital, Hartford, Connecticut, United States

Effect of Ramelteon on Smoking Abstinence

Phase 2
Completed
Conditions
Tobacco Use Disorder
Interventions
Drug: Placebo
First Posted Date
2015-09-25
Last Posted Date
2019-11-04
Lead Sponsor
University of Pennsylvania
Target Recruit Count
140
Registration Number
NCT02560324
Locations
🇺🇸

Center for Interdisciplinary Research on Nicotine Addiction, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, United States

Ramelteon in the Prevention of Post-operative Delirium

Phase 2
Completed
Conditions
Cognitive Disorders
Delayed Emergence From Anesthesia
Delirium
Delirium, Dementia, Amnestic, Cognitive Disorders
Interventions
First Posted Date
2014-12-24
Last Posted Date
2020-06-30
Lead Sponsor
Johns Hopkins University
Target Recruit Count
80
Registration Number
NCT02324153
Locations
🇺🇸

Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States

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

Phase 4
Completed
Conditions
Insomnia
Interventions
Drug: placebo
First Posted Date
2014-06-05
Last Posted Date
2015-07-28
Lead Sponsor
Duke University
Target Recruit Count
75
Registration Number
NCT02156271

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
Conditions
Insomnia
Interventions
First Posted Date
2014-06-02
Last Posted Date
2016-10-13
Lead Sponsor
Takeda
Target Recruit Count
236
Registration Number
NCT02153086

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

Completed
Conditions
Insomnia
Interventions
First Posted Date
2014-02-11
Last Posted Date
2016-07-14
Lead Sponsor
Takeda
Target Recruit Count
3339
Registration Number
NCT02058992

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

Phase 3
Withdrawn
Conditions
Bipolar Disorder
Interventions
First Posted Date
2012-09-14
Last Posted Date
2013-01-23
Lead Sponsor
Takeda
Registration Number
NCT01685151

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

Phase 3
Terminated
Conditions
Bipolar Disorder
Interventions
Drug: Placebo
First Posted Date
2012-08-31
Last Posted Date
2016-03-16
Lead Sponsor
Takeda
Target Recruit Count
535
Registration Number
NCT01677182
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