Trial · NCT00466193
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
NCT00466193, Phase 3, Completed, Transcept Pharmaceuticals; results first posted 2012-01-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia. Trials, record NCT00466193. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00466193
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
- NCT number
- NCT00466193
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 295 participants, actual
- Lead sponsor
- Transcept Pharmaceuticals
- Conditions
- Insomnia
- Interventions
- zolpidem tartrate sublingual tablet, Placebo
- First posted
- 2007-04-27
- Last updated
- 2012-02-14
- Results first posted
- 2012-01-20
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline | Weeks -1 to 0 | Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication? |
| Primary | Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment | Weeks 1 to 4 | Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication? |
| Secondary | Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline | Weeks -1 to 0 | Total sleep time in minutes after waking in the middle of the night. The values were recorded by participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how long did you sleep until you woke up this morning? |
| Secondary | Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment | Weeks 1 to 4 | Total sleep time in minutes after waking in the middle of the night. The values were recorded by participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how long did you sleep until you woke up this morning? |
| Secondary | Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline. | Weeks -1 to 0 | Number of awakenings following middle-of-the-night awakening were recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how many times did you wake up again before waking up in the morning? |
| Secondary | Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment | Weeks 1 to 4 | Number of awakenings following middle-of-the-night awakening were recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how many times did you wake up again before waking up in the morning? |
| Secondary | Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline | Weeks -1 to 0 | The number of minutes subjects reported being awake after onset of sleep following middle-of-the-night awakening during the baseline period. Values were recorded using a telephone interactive voice response system (IVRS) to answer the question: Considering all of these awakenings (after taking study medication and returning to sleep), how long were you awake from the time you went back to sleep after dosing until you got out of bed this morning? |
| Secondary | Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment | Weeks 1 to 4 | The number of minutes subjects reported being awake after onset of sleep following middle-of-the-night awakening during double-blind treatment. Values were recorded using a telephone interactive voice response system (IVRS) to answer the question: Considering all of these awakenings (after taking study medication and returning to sleep), how long were you awake from the time you went back to sleep after dosing until you got out of bed this morning? |
| Secondary | Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening at Baseline | Weeks -1 to 0 | Morning sleepiness was assessed using a 9-point sleepiness scale (1=very sleepy to 9=wide awake and alert). During the baseline period, all participants received placebo. |
| Secondary | Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening During Double-blind Treatment | Weeks 1 to 4 | Morning sleepiness was assessed using a 9-point sleepiness scale (1=very sleepy to 9=wide awake and alert). Values are from dosing nights during double-blind treatment. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline | Weeks -1 to 0 | Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline | Weeks -1 to 0 | Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment | Weeks 1 to 4 | Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline. | Weeks -1 to 0 | Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value. | percentage of participants | NUMBER |
| SECONDARY | Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment | Weeks 1 to 4 | Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value. | percentage of participants | NUMBER |
| SECONDARY | Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline | Weeks -1 to 0 | Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value. | percentage of participants | NUMBER |
| SECONDARY | Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment | Weeks 1 to 4 | Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value. | percentage of participants | NUMBER |
| SECONDARY | Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening at Baseline | Weeks -1 to 0 | Safety population: participants who took at least one dose of study medication post-randomization. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment | Weeks 1 to 4 | Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening During Double-blind Treatment | Weeks 1 to 4 | Safety population: participants who took at least one dose of study medication post-randomization. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline | Zolpidem 3.5 mg | 68.13 | 95% Confidence Interval 63.90 to 72.64 | minutes | |
| Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline | Placebo | 69.42 | 95% Confidence Interval 65.03 to 74.10 | minutes | |
| Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline | Zolpidem 3.5 mg | 241.2 | 95% Confidence Interval 229.1 to 253.4 | minutes | |
| Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline | Placebo | 222.9 | 95% Confidence Interval 210.5 to 235.3 | minutes | |
| Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment | Zolpidem 3.5 mg | 264.1 | 95% Confidence Interval 255.7 to 272.4 | minutes | |
| Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment | Placebo | 255.0 | 95% Confidence Interval 246.5 to 263.5 | minutes | |
| Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline. | Zolpidem 3.5 mg | 0 awakenings | 16.7 | percentage of participants | |
| Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline. | Placebo | 0 awakenings | 11.8 | percentage of participants | |
| Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline. | Zolpidem 3.5 mg | >0 and <=1 awakenings | 46.0 | percentage of participants | |
| Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline. | Placebo | >0 and <=1 awakenings | 45.1 | percentage of participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zolpidem 3.5 mg | 150 | |
| Overall Study | STARTED | Placebo | 145 | |
| Overall Study | COMPLETED | Zolpidem 3.5 mg | 138 | |
| Overall Study | COMPLETED | Placebo | 137 | |
| Overall Study | NOT COMPLETED | Zolpidem 3.5 mg | 12 | |
| Overall Study | NOT COMPLETED | Placebo | 8 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zolpidem 3.5 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Zolpidem 3.5 mg | 0 | 150 |
| Total, other adverse events | Placebo | 0 | 145 |
| Total, serious adverse events | Zolpidem 3.5 mg | 0 | 150 |
| Total, serious adverse events | Placebo | 0 | 145 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Zolpidem 3.5 mg vs Placebo: serious adverse events |
Source 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/NCT00466193
GET https://conductscience.org/api/trials/v1/NCT00466193/results?page=2