Randomized, Double Blind, Placebo-Controlled Study to Assess Whether the Administration of Ramelteon Could Facilitate the Discontinuation of Zolpidem (Ambien®) ≥10 mg Therapy in Subjects With Chronic Insomnia
Overview
- Phase
- Phase 4
- Intervention
- Ramelteon and zolpidem
- Conditions
- Chronic Insomnia
- Sponsor
- Takeda
- Enrollment
- 135
- Primary Endpoint
- Percentage of Participants Who Discontinued Zolpidem Therapy
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief 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.
Detailed Description
Approximately 60 to 70 million adults in the United States alone are affected by insomnia. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and irritability. Recent epidemiologic research focusing on the quality of life has identified significant insomnia-related morbidities that relate to work productivity, health care utilization, and risk of depression. Insomnia is associated with diminished work output, absenteeism, and greater rates of accidents. Zolpidem is the most commonly prescribed hypnotic in the United States for patients suffering from insomnia. The purpose of this study is to assess whether ramelteon therapy can facilitate the discontinuation of benzodiazepine therapy in long term users. Subject participation in this study is anticipated to be about 17 weeks. Subjects were screened and enrolled in a 4-week placebo run-in period, may have been randomized to a 10-week double-blind treatment period, and may have completed with a 2-week open-label treatment period. In the double-blind treatment period, subjects were randomized to one of two treatments: either ramelteon 8 mg tablets taken orally once-daily with concomitant current zolpidem therapy or to placebo-matching tablets once daily with concomitant current zolpidem therapy. Subjects incrementally reduced zolpidem therapy by dose, frequency, or both for up to 10 weeks. Only those subjects who completed the double-blind treatment period and had achieved a 50% reduction in zolpidem therapy during the double-blind treatment period participated in the open-label treatment period in which 8 mg ramelteon was administered. Zolpidem consumed during the open-label treatment period was recorded.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Ramelteon 8 mg QD and current Zolpidem therapy
Zolpidem therapy will be reduced by dose, frequency, or both for up to 10 weeks.
Intervention: Ramelteon and zolpidem
Placebo QD and current Zolpidem therapy
Zolpidem therapy will be reduced by dose, frequency, or both for up to 10 weeks.
Intervention: Placebo and zolpidem
Outcomes
Primary Outcomes
Percentage of Participants Who Discontinued Zolpidem Therapy
Time Frame: Week 10
Participants reduced zolpidem incrementally from Week 3 to Week 10 of the double-blind treatment period (DBTP). A participant who did not take any zolpidem during the last 7 days of the DBTP was defined as having completely discontinued zolpidem by that time point. The number of subjects who discontinued zolpidem at the end of the DBTP was summarized.
Secondary Outcomes
- Change From Baseline in Weekly Zolpidem Dosage During Weeks 1-2(Baseline and Weeks 1-2)
- Change From Baseline in Weekly Zolpidem Dosage During Weeks 3-4(Baseline and Weeks 3-4)
- Change From Baseline in Weekly Zolpidem Dosage During Weeks 5-6(Baseline and Weeks 5-6)
- Change From Baseline in Weekly Zolpidem Dosage During Weeks 7-8(Baseline and Weeks 7-8)
- Change From Baseline in Weekly Zolpidem Dosage During Weeks 9-10(Baseline and Weeks 9-10)
- Change From Baseline in Weekly Zolpidem Frequency During Weeks 1-2(Baseline and Weeks 1-2)
- Change From Baseline in Weekly Zolpidem Frequency During Weeks 3-4(Weeks 3-4)
- Change From Baseline in Weekly Zolpidem Frequency During Weeks 5-6(Weeks 5-6)
- Change From Baseline in Weekly Zolpidem Frequency During Weeks 7-8(Baseline and Weeks 7-8)
- Change From Baseline in Weekly Zolpidem Frequency During Weeks 9-10(Baseline and Weeks 9-10)
- Participants Who Completely Discontinued Zolpidem at the End of Double-Blind Treatment Period, by Method of Discontinuation(Weeks 1-10)
- Participants Who Achieved a 50% Reduction in Zolpidem Dosage at the End of the Double-Blind Treatment Period(Baseline and Week 10)
- Participants Who Achieved a 50% Reduction in Zolpidem Dosage at Any Time During the Double-Blind Treatment Period(Baseline and Weeks 1-10)