Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-01 @ 7:36 PM
Study NCT ID:
NCT00466193
Status:
COMPLETED
Last Update Posted:
2012-02-14
First Post:
2007-04-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077334', 'term': 'Zolpidem'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-733-1333', 'title': 'Clinical Leader', 'organization': 'Purdue Pharma LP'}, 'certainAgreement': {'otherDetails': 'Sponsor agrees to review manuscripts within sixty (60) days prior to submission for publication. If sponsor determines the publication includes patentable subject matter, sponsor may take an additional sixty (60) days to permit the filing of any patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Weeks 1-4', 'eventGroups': [{'id': 'EG000', 'title': 'Zolpidem 3.5 mg', 'description': 'Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.', 'otherNumAtRisk': 150, 'otherNumAffected': 0, 'seriousNumAtRisk': 150, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo sublingual tablet taken following a middle-of-the-night awakening.', 'otherNumAtRisk': 145, 'otherNumAffected': 0, 'seriousNumAtRisk': 145, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zolpidem 3.5 mg', 'description': 'Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo sublingual tablet taken following a middle-of-the-night awakening.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.13', 'groupId': 'OG000', 'lowerLimit': '63.90', 'upperLimit': '72.64'}, {'value': '69.42', 'groupId': 'OG001', 'lowerLimit': '65.03', 'upperLimit': '74.10'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks -1 to 0', 'description': '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?', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zolpidem 3.5 mg', 'description': 'Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo sublingual tablet taken following a middle-of-the-night awakening.'}], 'classes': [{'categories': [{'measurements': [{'value': '241.2', 'groupId': 'OG000', 'lowerLimit': '229.1', 'upperLimit': '253.4'}, {'value': '222.9', 'groupId': 'OG001', 'lowerLimit': '210.5', 'upperLimit': '235.3'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks -1 to 0', 'description': '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?', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zolpidem 3.5 mg', 'description': 'Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo sublingual tablet taken following a middle-of-the-night awakening.'}], 'classes': [{'categories': [{'measurements': [{'value': '264.1', 'groupId': 'OG000', 'lowerLimit': '255.7', 'upperLimit': '272.4'}, {'value': '255.0', 'groupId': 'OG001', 'lowerLimit': '246.5', 'upperLimit': '263.5'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 1 to 4', 'description': '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?', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zolpidem 3.5 mg', 'description': 'Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo sublingual tablet taken following a middle-of-the-night awakening.'}], 'classes': [{'title': '0 awakenings', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}]}]}, {'title': '>0 and <=1 awakenings', 'categories': [{'measurements': [{'value': '46.0', 'groupId': 'OG000'}, {'value': '45.1', 'groupId': 'OG001'}]}]}, {'title': '>1 and <=2 awakenings', 'categories': [{'measurements': [{'value': '26.0', 'groupId': 'OG000'}, {'value': '27.1', 'groupId': 'OG001'}]}]}, {'title': '>2 awakenings', 'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000'}, {'value': '16.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks -1 to 0', 'description': '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?', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zolpidem 3.5 mg', 'description': 'Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo sublingual tablet taken following a middle-of-the-night awakening.'}], 'classes': [{'title': '0 awakenings', 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}]}]}, {'title': '>0 and <=1 awakenings', 'categories': [{'measurements': [{'value': '46.0', 'groupId': 'OG000'}, {'value': '43.1', 'groupId': 'OG001'}]}]}, {'title': '>1 and <=2 awakenings', 'categories': [{'measurements': [{'value': '17.3', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': '>2 awakenings', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '15.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'p-value is for treatment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 1 to 4', 'description': '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?', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zolpidem 3.5 mg', 'description': 'Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo sublingual tablet taken following a middle-of-the-night awakening.'}], 'classes': [{'title': 'No wake time', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}]}]}, {'title': '>0 to 20 minutes', 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000'}, {'value': '14.6', 'groupId': 'OG001'}]}]}, {'title': '21 to 60 minutes', 'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000'}, {'value': '32.6', 'groupId': 'OG001'}]}]}, {'title': '>60 minutes', 'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000'}, {'value': '41.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks -1 to 0', 'description': '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?', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zolpidem 3.5 mg', 'description': 'Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo sublingual tablet taken following a middle-of-the-night awakening.'}], 'classes': [{'title': 'No wake time', 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}]}]}, {'title': '>0 to 20 minutes', 'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000'}, {'value': '26.4', 'groupId': 'OG001'}]}]}, {'title': '21 to 60 minutes', 'categories': [{'measurements': [{'value': '26.0', 'groupId': 'OG000'}, {'value': '31.9', 'groupId': 'OG001'}]}]}, {'title': '> 60 minutes', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'p-value is for treatment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 1 to 4', 'description': '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?', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zolpidem 3.5 mg', 'description': 'Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo sublingual tablet taken following a middle-of-the-night awakening.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.87', 'groupId': 'OG000', 'lowerLimit': '4.61', 'upperLimit': '5.13'}, {'value': '4.71', 'groupId': 'OG001', 'lowerLimit': '4.45', 'upperLimit': '4.97'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks -1 to 0', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: participants who took at least one dose of study medication post-randomization.'}, {'type': 'PRIMARY', 'title': 'Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zolpidem 3.5 mg', 'description': 'Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo sublingual tablet taken following a middle-of-the-night awakening.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.22', 'groupId': 'OG000', 'lowerLimit': '35.06', 'upperLimit': '41.66'}, {'value': '56.37', 'groupId': 'OG001', 'lowerLimit': '51.63', 'upperLimit': '61.56'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 1 to 4', 'description': '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?', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening During Double-blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zolpidem 3.5 mg', 'description': 'Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo sublingual tablet taken following a middle-of-the-night awakening.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.59', 'groupId': 'OG000', 'lowerLimit': '5.42', 'upperLimit': '5.76'}, {'value': '5.24', 'groupId': 'OG001', 'lowerLimit': '5.06', 'upperLimit': '5.41'}]}]}], 'analyses': [{'pValue': '0.0041', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for treatment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 1 to 4', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: participants who took at least one dose of study medication post-randomization.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zolpidem 3.5 mg', 'description': 'Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo sublingual tablet taken following a middle-of-the-night awakening.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '145'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'comment': 'One patient did not report at least one Latency Sleep Onset following middle-of-the-night awakening.', 'groupId': 'FG001', 'numSubjects': '137'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Patient refused Visit 4 procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Seven hundred and three (703) subjects were screened. Three hundred (300) subjects were randomized, but 5 subjects never took drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Zolpidem 3.5 mg', 'description': 'Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo sublingual tablet taken following a middle-of-the-night awakening.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.3', 'spread': '11.38', 'groupId': 'BG000'}, {'value': '43.4', 'spread': '11.30', 'groupId': 'BG001'}, {'value': '42.8', 'spread': '11.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '26.17', 'spread': '3.860', 'groupId': 'BG000'}, {'value': '26.55', 'spread': '3.754', 'groupId': 'BG001'}, {'value': '26.35', 'spread': '3.807', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index is an estimate of body fat based on body weight divided by height squared.', 'unitOfMeasure': 'kilogram per square meter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '74.27', 'spread': '15.050', 'groupId': 'BG000'}, {'value': '75.73', 'spread': '13.434', 'groupId': 'BG001'}, {'value': '74.99', 'spread': '14.273', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 295}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-10', 'studyFirstSubmitDate': '2007-04-24', 'resultsFirstSubmitDate': '2011-12-15', 'studyFirstSubmitQcDate': '2007-04-24', 'lastUpdatePostDateStruct': {'date': '2012-02-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-12-15', 'studyFirstPostDateStruct': {'date': '2007-04-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline', 'timeFrame': 'Weeks -1 to 0', 'description': '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?'}, {'measure': 'Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment', 'timeFrame': 'Weeks 1 to 4', 'description': '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?'}], 'secondaryOutcomes': [{'measure': 'Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline', 'timeFrame': 'Weeks -1 to 0', 'description': '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?'}, {'measure': 'Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment', 'timeFrame': 'Weeks 1 to 4', 'description': '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?'}, {'measure': 'Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline.', 'timeFrame': 'Weeks -1 to 0', 'description': '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?'}, {'measure': 'Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment', 'timeFrame': 'Weeks 1 to 4', 'description': '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?'}, {'measure': 'Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline', 'timeFrame': 'Weeks -1 to 0', 'description': '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?'}, {'measure': 'Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment', 'timeFrame': 'Weeks 1 to 4', 'description': '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?'}, {'measure': 'Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening at Baseline', 'timeFrame': 'Weeks -1 to 0', 'description': '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.'}, {'measure': 'Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening During Double-blind Treatment', 'timeFrame': 'Weeks 1 to 4', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Insomnia'], 'conditions': ['Insomnia']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with history of sleeplessness\n\nExclusion Criteria:\n\n* Allergic to investigational drug\n* Any conditions and medications that may interfere with study drug evaluation'}, 'identificationModule': {'nctId': 'NCT00466193', 'briefTitle': 'A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Transcept Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of the Zolpidem Tartrate Sublingual Tablet in Adult Subjects With Insomnia Characterized by Difficulty Returning to Sleep After Awakening in the Middle-of-the-Night (MOTN)', 'orgStudyIdInfo': {'id': 'ZI-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zolpidem 3.5mg', 'interventionNames': ['Drug: zolpidem tartrate sublingual tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'zolpidem tartrate sublingual tablet', 'type': 'DRUG', 'otherNames': ['Intermezzo®'], 'description': '3.5 milligram zolpidem tartrate sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.', 'armGroupLabels': ['Zolpidem 3.5mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Transcept Investigational Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Andrew Krystal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Neurophysiology Training Program, Duke University'}, {'name': 'Thomas Roth, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sleep Disorders and Research Center, Henry Ford Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Transcept Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}