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Ramelteon 8 mg QD for Chronic Insomnia

Phase 3
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

The purpose of this study is to evaluate subjectively reported treatment effects of ramelteon, once daily (QD), in adults with chronic insomnia.

Eligible Conditions
  • Chronic Insomnia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2008 Phase 4 trial • 50 Patients • NCT00502320
4%
Depression
4%
Nightmares
4%
Anxiety
4%
Fatigue
4%
Worsening depression leading to hospitalization
4%
Insomnia Exacerbation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ramelteon
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ramelteon 8 mg QDExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ramelteon
FDA approved

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,232 Previous Clinical Trials
4,146,815 Total Patients Enrolled
VP Clinical ScienceStudy DirectorTakeda
16 Previous Clinical Trials
4,724 Total Patients Enrolled
~53 spots leftby Sep 2025
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