Solriamfetol and CBT-I in Patients With Insomnia Disorder

NCT05838430 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 850945
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 \[CBT-I\]). Ultimately, this study will test whether wake extension (regardless of how it is achieved) will consolidate sleep and improve sleep continuity.

Conditions

Insomnia

Keywords

Insomnia; Medication; Fatigue; Performance; CBT-I

Outcome Measures

Primary Outcomes (1)

• 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).

  End of Treatment (12 Weeks)

Secondary Outcomes (7)

• Insomnia Severity

  End of Treatment (12 Weeks)

• Daytime Sleepiness

  End of Treatment (12 Weeks)

• Fatigue

  End of Treatment (12 Weeks)

• Adherence to "sleep rescheduling"

  Throughout treatment (over 8 weeks)

• Daytime Function

  End of Treatment (12 Weeks)

Study Arms (4)

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

Interventions

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.

Solriamfetol Only; Solriamfetol+ CBT-I

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.

Placebo + CBT-I; Solriamfetol+ CBT-I

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 Only; Solriamfetol Only

Placebo OTHER

Placebo, identical in appearance to the active drug.

Placebo + CBT-I; Placebo Only

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Axsome Therapeutics, Inc.: collaborator

Study Sites (1)

University of Pennsylvania, Behavioral Sleep Medicine Program

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Fatigue

Interventions

solriamfetol; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding only applies to the medication arm. The randomization schedule was developed by our statistician and sent directly to research pharmacy for implementation. The four arms are as follows: 1. Solriamfetol + CBT-I 2. Placebo + CBT-I 3. Solriamfetol Only 4. Placebo Only All conditions engage in monitoring and assessment.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: May 1, 2023
• Study Start: July 31, 2023
• Primary Completion: January 31, 2026
• Study Completion: April 30, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)