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Melatonin Receptor Agonist

Ramelteon 8 mg QD and current Zolpidem therapy for Chronic Insomnia

Phase 4
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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and weeks 9-10
Awards & highlights

Summary

The purpose of this study is to assess whether ramelteon, once daily (QD), can facilitate the discontinuation of zolpidem in subjects with chronic insomnia.

Eligible Conditions
  • Chronic Insomnia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and weeks 9-10
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and weeks 9-10 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Who Discontinued Zolpidem Therapy
Secondary study objectives
Change From Baseline in Weekly Zolpidem Dosage During Weeks 1-2
Change From Baseline in Weekly Zolpidem Dosage During Weeks 3-4
Change From Baseline in Weekly Zolpidem Dosage During Weeks 5-6
+10 more

Side effects data

From 2008 Phase 4 trial • 135 Patients • NCT00492232
8%
Upper Respiratory Tract Infections
6%
Dizziness
3%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ramelteon 8 mg QD
Placebo QD

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ramelteon 8 mg QD and current Zolpidem therapyExperimental Treatment1 Intervention
Zolpidem therapy will be reduced by dose, frequency, or both for up to 10 weeks.
Group II: Placebo QD and current Zolpidem therapyPlacebo Group1 Intervention
Zolpidem therapy will be reduced by dose, frequency, or both for up to 10 weeks.
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
4,147,761 Total Patients Enrolled
Medical Director Clinical ScienceStudy DirectorTakeda Global Research & Development Center
197 Previous Clinical Trials
63,094 Total Patients Enrolled
~7 spots leftby Sep 2025
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