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Completed

NCT Number: NCT05838430

Solriamfetol and CBT-I 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.

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Key information

Conditions

Insomnia Dyssomnias Fatigue Mental Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Pennsylvania, Behavioral Sleep Medicine Program

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Solriamfetol 75 MG

Drug

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)

Behavioral

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.

monitoring

Other

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.

Placebo

Other

Placebo, identical in appearance to the active drug.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Insomnia Severity

    Time frame: End of Treatment (12 Weeks)

    As measured by the Insomnia Severity Index. Range of scores = 0 to 28, with a higher score indicating more severe insomnia.

  2. Daytime Sleepiness

    Time frame: End of Treatment (12 Weeks)

    As measured by the Epworth Sleepiness Scale. Range of scores = 0 to 24, with a higher score indicating more severe daytime sleepiness.

  3. Fatigue

    Time frame: End of Treatment (12 Weeks)

    As measured by Fatigue Severity Scale. Range of scores = 9 to 63, with a higher score indicating more severe fatigue.

  4. Adherence to "sleep rescheduling"

    Time frame: Throughout treatment (over 8 weeks)

    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.

  5. Daytime Function

    Time frame: End of Treatment (12 Weeks)

    As measured by Functional Outcomes of Sleep Questionnaire (FOSQ-10) Range of scores = 10-40, with lower scores indicating more severe daytime function impairment.

  6. Mood Disturbance

    Time frame: End of Treatment (12 Weeks)

    Total Mood Disturbance Score on Profile of Mood States Range of scores = 0-20, with higher scores indicating more severe mood disturbance.

  7. Alertness

    Time frame: Throughout treatment (over 8 weeks)

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Axsome Therapeutics, Inc.

Registry information

Official study title

The Effects of Solriamfetol and CBT-I (Alone and in Combination) on Sleep Continuity, Sleepiness, Fatigue, and Performance in Patients With Insomnia Disorder

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 1, 2023
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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