Trial · NCT00492232
Facilitation of Zolpidem (≥10 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia
NCT00492232, Phase 4, Completed, Takeda; results first posted 2009-07-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Facilitation of Zolpidem (≥10 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia. Trials, record NCT00492232. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00492232
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Facilitation of Zolpidem (≥10 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia
- NCT number
- NCT00492232
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 135 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Chronic Insomnia
- Interventions
- Ramelteon and zolpidem, Placebo and zolpidem
- First posted
- 2007-06-27
- Last updated
- 2010-07-20
- Results first posted
- 2009-07-17
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Discontinued Zolpidem Therapy | 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 | Change From Baseline in Weekly Zolpidem Dosage During Weeks 1-2 | Baseline and Weeks 1-2 | Dosages of zolpidem taken were recorded during Weeks 1-2 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7. |
| Secondary | Change From Baseline in Weekly Zolpidem Dosage During Weeks 3-4 | Baseline and Weeks 3-4 | Dosages of zolpidem taken were recorded during Weeks 3-4 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7. |
| Secondary | Change From Baseline in Weekly Zolpidem Dosage During Weeks 5-6 | Baseline and Weeks 5-6 | Dosages of zolpidem taken were recorded during Weeks 5-6 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7. |
| Secondary | Change From Baseline in Weekly Zolpidem Dosage During Weeks 7-8 | Baseline and Weeks 7-8 | Dosages of zolpidem taken were recorded during Weeks 7-8 of the double blind period. Differences in dosages from baseline were summarized. |
| Secondary | Change From Baseline in Weekly Zolpidem Dosage During Weeks 9-10 | Baseline and Weeks 9-10 | Dosages of zolpidem taken were recorded during Weeks 9-10 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7. |
| Secondary | Change From Baseline in Weekly Zolpidem Frequency During Weeks 1-2 | Baseline and Weeks 1-2 | The number of nights zolpidem was taken was recorded during Weeks 1-2 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from BL were summarized. |
| Secondary | Change From Baseline in Weekly Zolpidem Frequency During Weeks 3-4 | Weeks 3-4 | The number of nights zolpidem was taken was recorded during Weeks 3-4 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized. |
| Secondary | Change From Baseline in Weekly Zolpidem Frequency During Weeks 5-6 | Weeks 5-6 | The number of nights zolpidem was taken was recorded during Weeks 5-6 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized. |
| Secondary | Change From Baseline in Weekly Zolpidem Frequency During Weeks 7-8 | Baseline and Weeks 7-8 | The number of nights zolpidem was taken was recorded during Weeks 7-8 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Discontinued Zolpidem Therapy | Week 10 | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Weekly Zolpidem Dosage During Weeks 1-2 | Baseline and Weeks 1-2 | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP. | Dose (mg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Zolpidem Dosage During Weeks 3-4 | Baseline and Weeks 3-4 | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP. | Dose (mg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Zolpidem Dosage During Weeks 5-6 | Baseline and Weeks 5-6 | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP. | Dose (mg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Zolpidem Dosage During Weeks 7-8 | Baseline and Weeks 7-8 | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP. | Dose (mg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Zolpidem Dosage During Weeks 9-10 | Baseline and Weeks 9-10 | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP. | Dose (mg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Zolpidem Frequency During Weeks 1-2 | Baseline and Weeks 1-2 | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP. | nights per week | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Zolpidem Frequency During Weeks 3-4 | Weeks 3-4 | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP. | nights per week | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Zolpidem Frequency During Weeks 5-6 | Weeks 5-6 | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP. | nights per week | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Zolpidem Frequency During Weeks 7-8 | Baseline and Weeks 7-8 | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP. | nights per week | LEAST_SQUARES_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Discontinued Zolpidem Therapy | Ramelteon 8 mg QD | 28.8 | Percentage of participants | ||
| Percentage of Participants Who Discontinued Zolpidem Therapy | Placebo QD | 32.7 | Percentage of participants | ||
| Change From Baseline in Weekly Zolpidem Dosage During Weeks 1-2 | Ramelteon 8 mg QD | -11.8 | Standard Error 3.06 | Dose (mg) | |
| Change From Baseline in Weekly Zolpidem Dosage During Weeks 1-2 | Placebo QD | -11.6 | Standard Error 3.11 | Dose (mg) | |
| Change From Baseline in Weekly Zolpidem Dosage During Weeks 3-4 | Ramelteon 8 mg QD | -35.3 | Standard Error 2.89 | Dose (mg) | |
| Change From Baseline in Weekly Zolpidem Dosage During Weeks 3-4 | Placebo QD | -35.6 | Standard Error 2.93 | Dose (mg) | |
| Change From Baseline in Weekly Zolpidem Dosage During Weeks 5-6 | Ramelteon 8 mg QD | -40.2 | Standard Error 3.18 | Dose (mg) | |
| Change From Baseline in Weekly Zolpidem Dosage During Weeks 5-6 | Placebo QD | -42.1 | Standard Error 3.22 | Dose (mg) | |
| Change From Baseline in Weekly Zolpidem Dosage During Weeks 7-8 | Ramelteon 8 mg QD | -52.1 | Standard Error 3.49 | Dose (mg) | |
| Change From Baseline in Weekly Zolpidem Dosage During Weeks 7-8 | Placebo QD | -49.9 | Standard Error 3.49 | Dose (mg) |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Placebo Run-in | STARTED | Ramelteon 8 mg QD | 0 | |
| Placebo Run-in | STARTED | Placebo QD | 205 | |
| Placebo Run-in | COMPLETED | Ramelteon 8 mg QD | 0 | |
| Placebo Run-in | COMPLETED | Placebo QD | 135 | |
| Placebo Run-in | NOT COMPLETED | Ramelteon 8 mg QD | 0 | |
| Placebo Run-in | NOT COMPLETED | Placebo QD | 70 | |
| Double-Blind Treatment | STARTED | Ramelteon 8 mg QD | 65 | |
| Double-Blind Treatment | STARTED | Placebo QD | 70 | |
| Double-Blind Treatment | COMPLETED | Ramelteon 8 mg QD | 47 | |
| Double-Blind Treatment | COMPLETED | Placebo QD | 45 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper Respiratory Tract Infections | Infections and infestations | Ramelteon 8 mg QD | 5 | 64 | 5 |
| other | Upper Respiratory Tract Infections | Infections and infestations | Placebo QD | 2 | 70 | 2 |
| other | Dizziness | Nervous system disorders | Ramelteon 8 mg QD | 4 | 64 | 5 |
| other | Dizziness | Nervous system disorders | Placebo QD | 1 | 70 | 1 |
| other | Headache | Nervous system disorders | Ramelteon 8 mg QD | 2 | 64 | 2 |
| other | Headache | Nervous system disorders | Placebo QD | 4 | 70 | 4 |
| serious | Coronary Artery Disease | Cardiac disorders | Ramelteon 8 mg QD | 0 | 64 | 0 |
| serious | Coronary Artery Disease | Cardiac disorders | Placebo QD | 1 | 70 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ramelteon 8 mg QD | ||
| Total, all-cause mortality | Placebo QD | ||
| Total, other adverse events | Ramelteon 8 mg QD | 11 | 64 |
| Total, other adverse events | Placebo QD | 7 | 70 |
| Total, serious adverse events | Ramelteon 8 mg QD | 0 | 64 |
| Total, serious adverse events | Placebo QD | 1 | 70 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ramelteon 8 mg QD vs Placebo QD: Participants Who Achieved a 50% Reduction in Zolpidem Dosage at the End of the Double-Blind Treatment Period | Trial comparisons |
| Ramelteon 8 mg QD vs Placebo QD: Participants Who Achieved a 50% Reduction in Zolpidem Dosage at Any Time During the Double-Blind Treatment Period | Trial comparisons |
| Ramelteon 8 mg QD vs Placebo QD: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00492232
GET https://conductscience.org/api/trials/v1/NCT00492232/results?page=2