Trial · NCT04468776

CBT-I or Zolpidem/Trazodone for Insomnia

NCT04468776, Phase 4, Completed, California Pacific Medical Center Research Institute; results first posted 2025-02-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. CBT-I or Zolpidem/Trazodone for Insomnia. Trials, record NCT04468776. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04468776

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: CBT-I or Zolpidem/Trazodone for Insomnia
NCT number: NCT04468776
Status: Completed
Phases: Phase 4
Enrollment: 155 participants, actual
Lead sponsor: California Pacific Medical Center Research Institute
Conditions: Chronic Insomnia
Interventions: Zolpidem, Internet Cognitive Behavioral Therapy for Insomnia (CBT-I), Trazodone
First posted: 2020-07-13
Last updated: 2025-02-24
Results first posted: 2025-02-24

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Insomnia Symptom Severity	Baseline, 6 months	Change in Insomnia Severity Index score from baseline to follow-up. The Insomnia Severity Index is a 7-item self-report questionnaire that measures severity of insomnia symptoms during the last two weeks. Each item is scored 0 (no problem) to 4 (very severe problem) and total between 0-28, with higher scores indicating more severe insomnia symptoms. Change is estimated mean change from mixed-effects linear regression model. Fixed effects: Baseline ISI, Treatment Arm, Visit and Treatment Arm\*Visit interaction. Random effects: intercept for Subject, nested within Site.
Secondary	Number of Participants With Treatment Response of Insomnia Symptoms	Baseline, 6 months	Treatment response defined as a ≥6 point reduction in Insomnia Severity Index score from baseline to follow-up. The Insomnia Severity Index is a 7-item self-report questionnaire that measures severity of insomnia symptoms during the last two weeks. Each item is scored 0 (no problem) to 4 (very severe problem) and total between 0-28, with higher scores indicating more severe insomnia symptoms. Data presented as count of participants meeting treatment response criteria at 6 months.
Secondary	Number of Participants With Remission of Insomnia Symptoms	6 months	Remission of Insomnia symptoms defined as Insomnia Severity Index \<8 at follow-up. The Insomnia Severity Index is a 7-item self-report questionnaire that measures severity of insomnia symptoms during the last two weeks. Each item is scored 0 (no problem) to 4 (very severe problem) and total between 0-28, with higher scores indicating more severe insomnia symptoms. Data presented as count of participants meeting insomnia remission criteria at 6 months.
Other	Change in Anxiety and Depression	Baseline, 6 months	The Patient Health Questionnaire (PHQ-8) is an 8-item self-report measure for assessing depression severity. The items are summed to yield a score between 0 and 24, with higher scores indicating more frequent depression symptoms. The Generalized Anxiety Disorder (GAD-7) Scale is a 7-item self-report measure used for screening and assessing severity of GAD. The items are summed to yield a score between 0 and 21, with higher scores indicating more severe GAD symptoms. Change is estimated mean change in mixed-effects linear regression model. Fixed effects: Treatment Arm, Visit and Treatment Arm\*Visit interaction. Random effects: intercept for Subject, nested within Site.
Other	Change in Cognitive Function	Baseline, 6 months	The PROMIS Cognitive Function Short Form (8a) is an 8-item self-report measure related to executive functioning. Individual item responses range from 1 (very often) to 5 (never) and the total raw score is converted to standardized T-scores using established United States general adult population with a mean of 50 and a standard deviation of 10. Higher T-scores signify better cognitive function. Estimated mean change in T-score from baseline to follow-up is reported from mixed-effects linear regression model. Fixed effects: Treatment Arm, Visit and Treatment Arm\*Visit interaction. Random effects: intercept for Subject, nested within Site. Positive change indicates improved cognitive function.
Other	Change in Patient-Reported Health	Baseline, 6 months	The PROMIS Global Health is a 10-item self-report measure that assess general health and functioning. Item responses range from 1 (excellent/none) to 5 (poor/always) and a single pain item ranges from 0 (no pain) to 10 (worst pain). Physical and mental health sub-scores are calculated from 4 items each, and the total raw sub-scores (range: 4-20) are converted to T-scores using distributions standardized to mean 50 (SD 10) for the US general population. Higher score indicates greater health-related quality of life. The Medical Outcome Survey (SF-12) is a 12-item self-report measure of physical and mental health. The Physical Component Score (PCS) and Mental Component Score (MCS) sub-scores range 0-100; higher score indicates better health. Change is estimated mean change from baseline to follow-up in mixed-effects linear regression model. Fixed effects: Treatment Arm, Visit and Treatment Arm\*Visit interaction. Random effects: intercept for Subject, nested within Site.
Other	Change in Fatigue	Baseline, 6 months	The PROMIS Fatigue instrument is a 7-item self-report measure that assesses recent fatigue and how fatigue interfered with daily activities. Scores range from 7 to 35, with higher scores indicating greater fatigue. Change is estimated mean change from mixed-effects linear regression model. Fixed effects: Treatment Arm, Visit and Treatment Arm\*Visit interaction. Random effects: intercept for Subject, nested within Site.
Other	Change in Pain Intensity and Interference	Baseline, 6 months	The PROMIS Pain Intensity scale is a 3-item instrument used to assess how much pain a person has. Scores range from 3-15, with higher scores indicating greater pain intensity. The PROMIS Pain Interference scale is a 6-item instrument used to assess the consequences of pain in different domains of daily life. Scores range from 6-30, with higher scores indicating greater interference. Change is estimated mean change from mixed-effects linear regression model. Fixed effects: Treatment Arm, Visit and Treatment Arm\*Visit interaction. Random effects: intercept for Subject, nested within Site.
Other	Change in Pittsburgh Sleep Quality Index	Baseline, 6 months	The Pittsburgh Sleep Quality Index (PSQI) is an 18-item self-report measure that assesses sleep quality in the past month. These items are combined into seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction). The seven component scores are added to produce a global sleep quality score ranging from 0 to 21; higher total score indicates worse sleep quality. Change is estimated mean change from mixed-effects linear regression model. Fixed effects: Treatment Arm, Visit and Treatment Arm\*Visit interaction. Random effects: intercept for Subject, nested within Site.
Other	Change in Daytime Sleepiness	Baseline, 6 months	The Epworth Sleepiness Scale (ESS) is an 8-item self-report measure that assesses daytime sleepiness by asking about the likelihood of dozing in certain situations. Individual items are summed to yield the ESS score between 0 (never doze) to 24 (doze a lot) with higher scores indicating more sleepiness. Change is estimated mean change from mixed-effects linear regression model. Fixed effects: Treatment Arm, Visit and Treatment Arm\*Visit interaction. Random effects: intercept for Subject, nested within Site.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Insomnia Symptom Severity	Baseline, 6 months		change score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants With Treatment Response of Insomnia Symptoms	Baseline, 6 months	Only participants who completed the 6 months follow-up assessment were analyzed.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Remission of Insomnia Symptoms	6 months	Only participants who completed the 6 months follow-up assessment were analyzed.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Change in Anxiety and Depression	Baseline, 6 months		change score on a scale	LEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIED	Change in Cognitive Function	Baseline, 6 months		T-score	LEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIED	Change in Patient-Reported Health	Baseline, 6 months		change score on a scale	LEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIED	Change in Fatigue	Baseline, 6 months		change score on a scale	LEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIED	Change in Pain Intensity and Interference	Baseline, 6 months		change score on a scale	LEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIED	Change in Pittsburgh Sleep Quality Index	Baseline, 6 months		change score on a scale	LEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIED	Change in Daytime Sleepiness	Baseline, 6 months		change score on a scale	LEAST_SQUARES_MEAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group62

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Insomnia Symptom Severity	Medication (Zolpidem or Trazodone)		-8.05	95% Confidence Interval -9.44 to -6.65	change score on a scale
Change in Insomnia Symptom Severity	Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)		-7.82	95% Confidence Interval -9.32 to -6.32	change score on a scale
Change in Insomnia Symptom Severity	Combination		-10.19	95% Confidence Interval -11.66 to -8.73	change score on a scale
Number of Participants With Treatment Response of Insomnia Symptoms	Medication (Zolpidem or Trazodone)		22		Participants
Number of Participants With Treatment Response of Insomnia Symptoms	Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)		21		Participants
Number of Participants With Treatment Response of Insomnia Symptoms	Combination		31		Participants
Number of Participants With Remission of Insomnia Symptoms	Medication (Zolpidem or Trazodone)		16		Participants
Number of Participants With Remission of Insomnia Symptoms	Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)		13		Participants
Number of Participants With Remission of Insomnia Symptoms	Combination		16		Participants
Change in Anxiety and Depression	Medication (Zolpidem or Trazodone)	Patient Health Questionnaire (PHQ-8)	-2.37	95% Confidence Interval -3.39 to -1.36	change score on a scale

1 to 10 of 62Source ClinicalTrials.gov

See all 62 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Medication (Zolpidem or Trazodone)	49
Overall Study	STARTED	Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)	54
Overall Study	STARTED	Combination	52
Overall Study	9 Weeks Follow-up	Medication (Zolpidem or Trazodone)	40
Overall Study	9 Weeks Follow-up	Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)	37
Overall Study	9 Weeks Follow-up	Combination	41
Overall Study	6 Months Follow-up	Medication (Zolpidem or Trazodone)	38
Overall Study	6 Months Follow-up	Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)	32
Overall Study	6 Months Follow-up	Combination	34
Overall Study	12 Months Follow-up	Medication (Zolpidem or Trazodone)	37

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events50

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
other	Palpatations	Cardiac disorders	Medication (Zolpidem)	1	11
other	Palpatations	Cardiac disorders	Medication (Trazodone)	0	38
other	Palpatations	Cardiac disorders	Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)	0	54
other	Palpatations	Cardiac disorders	Combination (Zolpidem)	0	11
other	Palpatations	Cardiac disorders	Combination (Trazodone)	0	41
other	Fall	Injury, poisoning and procedural complications	Medication (Zolpidem)	1	11
other	Fall	Injury, poisoning and procedural complications	Medication (Trazodone)	2	38
other	Fall	Injury, poisoning and procedural complications	Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)	2	54
other	Fall	Injury, poisoning and procedural complications	Combination (Zolpidem)	0	11
other	Fall	Injury, poisoning and procedural complications	Combination (Trazodone)	4	41

1 to 10 of 50Source ClinicalTrials.gov

See all 50 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Medication (Zolpidem)	0	11
Total, all-cause mortality	Medication (Trazodone)	0	38
Total, all-cause mortality	Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)	0	54
Total, all-cause mortality	Combination (Zolpidem)	0	11
Total, all-cause mortality	Combination (Trazodone)	0	41
Total, other adverse events	Medication (Zolpidem)	4	11
Total, other adverse events	Medication (Trazodone)	10	38
Total, other adverse events	Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)	6	54
Total, other adverse events	Combination (Zolpidem)	2	11
Total, other adverse events	Combination (Trazodone)	7	41

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

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
Medication (Zolpidem or Trazodone) vs Combination: Medication Adherence

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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