InsomniaPhase 4NCT05838430
Solriamfetol and CBT-I in Patients With Insomnia Disorder
A Phase 4 study testing Solriamfetol 75 MG, Cognitive Behavioral Therapy for Insomnia (CBT-I) and Monitoring in people with Insomnia, run by University of Pennsylvania at 1 site in United States.
Trial summary
Medication is FDA approved. The objective of this project is to test the efficacy of solriamfetol for treating insomnia (alone and in combination with Cognitive Behavioral Therapy for Insomnia [CBT-I]). Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Solriamfetol 75 MG, Cognitive Behavioral Therapy for Insomnia (CBT-I) and Monitoring
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2023to 30 Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants will meet the diagnostic criteria for Insomnia Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- In addition, the complaint of disturbed sleep will meet the following criteria:
- ≥ 30 minutes to fall asleep (SL) and/or ≥ 2 awakenings per night of ≥ 15 minutes duration and/or wake after sleep onset (WASO) time of ≥ 30 minutes where total sleep time (TST) did not exceed 6 hours (unless sleep efficiency [SE] is ≤ 80%).
- The problem is present for > 3 nights per week.
- The problem duration exceeds ≥ 6 months.
- The complaint of impaired daytime function must include, although not limited to, the report of daytime fatigue, sleepiness, or both.
- Preferred regular sleep phase between 10:00 PM and 8:00 AM
- Must garner physician's assent from their primary care clinician
Who cannot join
- Use of medication expressly for the purpose of falling or staying asleep (e.g., trazodone/ desyrel, melatonin, Tylenol PM, Nyquil, Benadryl).
- Night shift work
- Compromised renal function
- Major Coronary Artery Disease and/or uncontrolled (with meds) Hypertension
- Planning to become pregnant, pregnant, and/or breastfeeding
- Unstable medical or psychiatric illness
Show all 13Show fewer
- Symptoms suggestive of sleep disorders other than insomnia
- Polysomnographic data indicating sleep disorders other than insomnia
- Evidence of active illicit substance use, abuse, or dependence
- Use of CNS active medications that are for treatment of insomnia or are thought to have caused insomnia as a side effect
- Inadequate language comprehension
- Current or past experience with CBT-I
- No access to the computers, I-Pads, or the internet
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania, Behavioral Sleep Medicine Program
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Effects of Solriamfetol and CBT-I (Alone and in Combination) on Sleep Continuity, Sleepiness, Fatigue, and Performance in Patients With Insomnia Disorder
Medication is FDA approved. The objective of this project is to test the efficacy of solriamfetol for treating insomnia (alone and in combination with Cognitive Behavioral Therapy for Insomnia [CBT-I]). Ultimately, this study will test whether wake extension (regardless of how it is achieved) will consolidate sleep and improve sleep continuity.
Read the detailed description
The current proposal is for a one-year study to investigate whether solriamfetol can improve sleep continuity and daytime performance, alone and in combination with Cognitive Behavioral Therapy for Insomnia. It is expected (given a common mechanism [wake extension]) that both Cognitive Behavioral Therapy for Insomnia and treatment with solriamfetol will improve sleep continuity, and that such effects will potentially be additive.
- Conditions
- Insomnia
- Being tested
- Solriamfetol 75 MG, Cognitive Behavioral Therapy for Insomnia (CBT-I), Monitoring, Placebo
- Keywords
- Insomnia, Medication, Fatigue, Performance, CBT-I
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solriamfetol 75 MGDrug
Solriamfetol (trade name Sunosi), is a norepinephrine-dopamine reuptake inhibitor available in 75mg and 150mg tablets for oral administration during the day. Solriamfetol's primary indication is to treat excessive daytime sleepiness (EDS) in patients diagnosed with obstructive sleep apnea or Narcolepsy. It binds to the dopamine and the norepinephrine transporters with affinities (Ki) of 14.2 μM and 3.7 μM, respectively),does not undergo significant metabolism in humans, and has a Tmax of ~2 hours (range 1.25-3.0 hours) and a T1/2 of ~7.1 hours.
Cognitive Behavioral Therapy for Insomnia (CBT-I)Behavioural
Treatment will be conducted via a HIPAA compliant video link (Zoom). Sessions 1-8 will follow our published protocol (published in 2005 by Springer).
Each session will be conducted individually and have a singular focus per session.
All sessions following the delivery of sleep restriction therapy \& stimulus control instructions (post Session 2) will include, as needed, management of non-adherence and/or time-in-bed titration.
MonitoringOther
No CBT-I will be administered, however, the tracking system used for CBT-I will be used for all subject conditions. This includes a sleep disorder symptoms screener, the administration of several questionnaires on a weekly basis, and the administration of daily sleep diaries online or via iPhone. Note: it is a common effect that regular monitoring of this type produces perceived clinical benefit.
PlaceboOther
Placebo, identical in appearance to the active drug.
| Study group | Role | What they receive |
|---|---|---|
| Solriamfetol+ CBT-I | Experimental | Not described Receives: Drug: Solriamfetol 75 MG; Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) |
| Solriamfetol Only | Experimental | Not described Receives: Drug: Solriamfetol 75 MG; Other: Monitoring |
| Placebo + CBT-I | Active comparator | Not described Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I); Other: Placebo |
| Placebo Only | Placebo comparator | Not described Receives: Other: Monitoring; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Continuity
Reflected by total wake time [time spent awake in bed] as measured via a web based self-report Sleep Diary. This variable is calculated by summing the estimates for sleep latency (SL), sleep after wake onset (WASO), and early morning awakening (EMA).
Measured: End of Treatment (12 Weeks)
Secondary outcomes (7)
Insomnia Severity
As measured by the Insomnia Severity Index. Range of scores = 0 to 28, with a higher score indicating more severe insomnia.
Measured: End of Treatment (12 Weeks)
Daytime Sleepiness
As measured by the Epworth Sleepiness Scale. Range of scores = 0 to 24, with a higher score indicating more severe daytime sleepiness.
Measured: End of Treatment (12 Weeks)
Fatigue
As measured by Fatigue Severity Scale. Range of scores = 9 to 63, with a higher score indicating more severe fatigue.
Measured: End of Treatment (12 Weeks)
Adherence to "sleep rescheduling"
Sleep rescheduling is a core component of Cognitive Behavioral Therapy for Insomnia, and adherence to it will be measured by the difference between prescribed time to bed and time out of bed and actual time to bed and time out of bed as reported on daily sleep diary entries.
Measured: Throughout treatment (over 8 weeks)
Daytime Function
As measured by Functional Outcomes of Sleep Questionnaire (FOSQ-10) Range of scores = 10-40, with lower scores indicating more severe daytime function impairment.
Measured: End of Treatment (12 Weeks)
Mood Disturbance
Total Mood Disturbance Score on Profile of Mood States Range of scores = 0-20, with higher scores indicating more severe mood disturbance.
Measured: End of Treatment (12 Weeks)
Alertness
As measured by average response time (milliseconds) on a Psychomotor Vigilance Test.
Range of scores = 0 to 180000 milliseconds, with a higher score indicating lower levels of alertness.
Measured: Throughout treatment (over 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start31 Jul 2023
- Primary completion31 Jan 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- A 2x2 mixed model design. The two factors will be 1) treatment (+/- solriamfetol and +/- CBT-I) and 2) Time (pre-post assessment, with additional follow-up data).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Axsome Therapeutics, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838430
- Sponsor's protocol ID
- 850945
- Status last verified
- May 2026
- First submitted
- 6 Mar 2023
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan on sharing IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Solriamfetol and CBT-I (Alone and in Combination) on Sleep Continuity, Sleepiness, Fatigue, and Performance in Patients With Insomnia Disorder
- ClinicalTrials.gov ID
- NCT05838430
- Acronym / sponsor ID
- 850945
- Conditions
- Insomnia
- Keywords
- Insomnia, Medication, Fatigue, Performance, CBT-I
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Axsome Therapeutics, Inc.
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Medication is FDA approved. The objective of this project is to test the efficacy of solriamfetol for treating insomnia (alone and in combination with Cognitive Behavioral Therapy for Insomnia [CBT-I]). Ultimately, this study will test whether wake extension (regardless of how it is achieved) will consolidate sleep and improve sleep continuity.
Detailed description
The current proposal is for a one-year study to investigate whether solriamfetol can improve sleep continuity and daytime performance, alone and in combination with Cognitive Behavioral Therapy for Insomnia. It is expected (given a common mechanism [wake extension]) that both Cognitive Behavioral Therapy for Insomnia and treatment with solriamfetol will improve sleep continuity, and that such effects will potentially be additive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A 2x2 mixed model design. The two factors will be 1) treatment (+/- solriamfetol and +/- CBT-I) and 2) Time (pre-post assessment, with additional follow-up data).
| Arm | Type | Receives |
|---|---|---|
| Solriamfetol+ CBT-I | Experimental | Drug: Solriamfetol 75 MG, Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) |
| Solriamfetol Only | Experimental | Drug: Solriamfetol 75 MG, Other: Monitoring |
| Placebo + CBT-I | Active comparator | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I), Other: Placebo |
| Placebo Only | Placebo comparator | Other: Monitoring, Other: Placebo |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participants will meet the diagnostic criteria for Insomnia Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- ≥ 30 minutes to fall asleep (SL) and/or ≥ 2 awakenings per night of ≥ 15 minutes duration and/or wake after sleep onset (WASO) time of ≥ 30 minutes where total sleep time (TST) did not exceed 6 hours (unless sleep efficiency [SE] is ≤ 80%).
- The problem is present for > 3 nights per week.
- The problem duration exceeds ≥ 6 months.
- The complaint of impaired daytime function must include, although not limited to, the report of daytime fatigue, sleepiness, or both.
Key exclusion criteria (13 listed)
- Use of medication expressly for the purpose of falling or staying asleep (e.g., trazodone/ desyrel, melatonin, Tylenol PM, Nyquil, Benadryl).
- Night shift work
- Compromised renal function
- Major Coronary Artery Disease and/or uncontrolled (with meds) Hypertension
- Planning to become pregnant, pregnant, and/or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solriamfetol 75 MGSolriamfetol (trade name Sunosi), is a norepinephrine-dopamine reuptake inhibitor available in 75mg and 150mg tablets for oral administration during the day. Solriamfetol's primary indication is to treat excessive daytime sleepiness (EDS) in patients diagnosed with obstructive sleep apnea or Narcolepsy. It binds to the dopamine and the norepinephrine transporters with affinities (Ki) of 14.2 μM and 3.7 μM, respectively),does not undergo significant metabolism in humans, and has a Tmax of ~2 hours (range 1.25-3.0 hours) and a T1/2 of ~7.1 hours. | Drug | Solriamfetol Only, Solriamfetol+ CBT-I |
| Cognitive Behavioral Therapy for Insomnia (CBT-I)Treatment will be conducted via a HIPAA compliant video link (Zoom). Sessions 1-8 will follow our published protocol (published in 2005 by Springer). Each session will be conducted individually and have a singular focus per session. All sessions following the delivery of sleep restriction therapy \& stimulus control instructions (post Session 2) will include, as needed, management of non-adherence and/or time-in-bed titration. | Behavioural | Placebo + CBT-I, Solriamfetol+ CBT-I |
| MonitoringNo CBT-I will be administered, however, the tracking system used for CBT-I will be used for all subject conditions. This includes a sleep disorder symptoms screener, the administration of several questionnaires on a weekly basis, and the administration of daily sleep diaries online or via iPhone. Note: it is a common effect that regular monitoring of this type produces perceived clinical benefit. | Other | Placebo Only, Solriamfetol Only |
| PlaceboPlacebo, identical in appearance to the active drug. | Other | Placebo + CBT-I, Placebo Only |
Primary outcome
Sleep Continuity
Time frame: End of Treatment (12 Weeks)
Reflected by total wake time [time spent awake in bed] as measured via a web based self-report Sleep Diary. This variable is calculated by summing the estimates for sleep latency (SL), sleep after wake onset (WASO), and early morning awakening (EMA).
7 secondary outcomes
Insomnia Severity
Time frame: End of Treatment (12 Weeks)
Daytime Sleepiness
Time frame: End of Treatment (12 Weeks)
Fatigue
Time frame: End of Treatment (12 Weeks)
Adherence to "sleep rescheduling"
Time frame: Throughout treatment (over 8 weeks)
Daytime Function
Time frame: End of Treatment (12 Weeks)
Mood Disturbance
Time frame: End of Treatment (12 Weeks)
Alertness
Time frame: Throughout treatment (over 8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No. The investigators do not plan on sharing IPD with other researchers.
Related trials for Insomnia
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Solriamfetol 75 MG, Cognitive Behavioral Therapy for Insomnia (CBT-I) and Monitoring in people with Insomnia, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Continuity (time frame: End of Treatment (12 Weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.