Solriamfetol + CBT-I for Insomnia
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Pennsylvania
Must not be taking: Sleep aids, CNS active
Disqualifiers: Night shift, Renal issues, CAD, others
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
Do I need to stop taking my current medications for the trial?
You will need to stop taking any medications that are used specifically to help you fall or stay asleep, such as trazodone, melatonin, or Tylenol PM. The trial does not specify other medication restrictions, but you should discuss your current medications with the trial team.
What data supports the effectiveness of the treatment Solriamfetol + CBT-I for Insomnia?
Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective in improving sleep and related outcomes in various populations, including cancer survivors and heart failure patients. It is considered the gold standard for treating insomnia, suggesting it could be beneficial when combined with other treatments like Solriamfetol.
12345Is Solriamfetol safe for humans?
Solriamfetol has been studied for excessive daytime sleepiness in conditions like narcolepsy and obstructive sleep apnea. It is generally well tolerated, with common side effects including headache, nausea, decreased appetite, insomnia, and anxiety. Unlike some stimulants, it does not have cardiac effects or withdrawal issues.
678910How is the drug Solriamfetol unique for treating insomnia?
Solriamfetol is unique because it is a selective dopamine and norepinephrine reuptake inhibitor, originally used to treat excessive daytime sleepiness in conditions like narcolepsy and obstructive sleep apnea. Unlike traditional insomnia treatments, it targets the brain's wakefulness-promoting pathways, potentially offering a novel approach when combined with cognitive behavioral therapy for insomnia (CBT-I).
69111213Eligibility Criteria
This trial is for adults with Insomnia Disorder as per DSM-5, experiencing specific sleep disturbances more than three nights a week for over six months. They must have daytime impairment and prefer to sleep between 10 PM and 8 AM. Excluded are pregnant or breastfeeding individuals, those with unstable health conditions, no internet access, night shift workers, renal issues, severe heart disease or hypertension, other sleep disorders, using certain medications or substances.Inclusion Criteria
I often feel very tired or sleepy during the day.
Participants will meet the diagnostic criteria for Insomnia Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
Must garner physician's assent from their primary care clinician
+4 more
Exclusion Criteria
No access to computers, I-Pads, or the internet
I experience symptoms of sleep disorders other than insomnia.
Night shift work
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive solriamfetol and/or CBT-I for insomnia treatment
12 weeks
Regular visits as per study protocol
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests the effectiveness of solriamfetol (a medication) alone and combined with Cognitive Behavioral Therapy for Insomnia (CBT-I). It aims to see if extending wakefulness can improve sleep quality. Participants will be monitored and may receive either the drug at a specified dose, CBT-I therapy sessions, placebo pills that contain no active drug or just monitoring without intervention.
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Solriamfetol+ CBT-IExperimental Treatment2 Interventions
Group II: Solriamfetol OnlyExperimental Treatment2 Interventions
Group III: Placebo + CBT-IActive Control2 Interventions
Group IV: Placebo OnlyPlacebo Group2 Interventions
Solriamfetol is already approved in United States for the following indications:
🇺🇸 Approved in United States as Sunosi for:
- Excessive daytime sleepiness in patients with narcolepsy
- Excessive daytime sleepiness in patients with obstructive sleep apnea
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Pennsylvania, Behavioral Sleep Medicine ProgramPhiladelphia, PA
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Who Is Running the Clinical Trial?
University of PennsylvaniaLead Sponsor
Axsome Therapeutics, Inc.Industry Sponsor
References
Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients. [2022]Individuals with cancer are disproportionately affected by sleep disturbance and insomnia relative to the general population. These problems can be a consequence of the psychological, behavioral, and physical effects of a cancer diagnosis and treatment. Insomnia often persists for years and, when combined with already high levels of cancer-related distress, may place cancer survivors at a higher risk of future physical and mental health problems and poorer quality of life. The recommended first-line treatment for insomnia is cognitive behavioral therapy for insomnia (CBT-I), a non-pharmacological treatment that incorporates cognitive and behavior-change techniques and targets dysfunctional attitudes, beliefs, and habits involving sleep. This article presents a comprehensive review of the literature examining the efficacy of CBT-I on sleep and psychological outcomes in cancer patients and survivors. The search revealed 12 studies (four uncontrolled, eight controlled) that evaluated the effects of CBT-I in cancer patients or survivors. Results suggest that CBT-I is associated with statistically and clinically significant improvements in subjective sleep outcomes in patients with cancer. CBT-I may also improve mood, fatigue, and overall quality of life, and can be successfully delivered through a variety of treatment modalities, making it possible to reach a broader range of patients who may not have access to more traditional programs. Future research in this area should focus on the translation of evidence into clinical practice in order to increase awareness and access to effective insomnia treatment in cancer care.
The future of cognitive behavioral therapy for insomnia: what important research remains to be done? [2018]The efficacy of cognitive-behavioral therapy for insomnia (CBT-I) to improve both short- and long-term outcomes in both uncomplicated and comorbid insomnia patients has been repeatedly and conclusively demonstrated. Further demonstrations of efficacy, per se, in additional comorbid insomnia populations are likely not the best use of limited energy and resources. Rather, we propose that future CBT-I research would be better focused on three key areas: (a) increasing treatment efficacy, particularly for more clinically relevant outcomes; (b) increasing treatment effectiveness and potential for translation into the community, with a particular focus on variants of CBT-I and alternative delivery modalities within primary healthcare systems; and (c) increasing CBT-I practitioner training and dissemination.
Effects of Cognitive Behavioral Therapy for Insomnia on Sleep-Related Cognitions Among Patients With Stable Heart Failure. [2020]Cognitive behavioral therapy for insomnia (CBT-I) improves insomnia and fatigue among chronic heart failure (HF) patients, but the extent to which sleep-related cognitions explain CBT-I outcomes in these patients is unknown. We examined the effects of CBT-I on sleep-related cognitions, associations between changes in sleep-related cognitions and changes in sleep and symptoms after CBT-I, and the extent to which cognitions mediated the effects of CBT-I.
Testing delivery of components of cognitive behavioral therapy for insomnia to breast cancer survivors by smart speaker: a study protocol. [2022]Insomnia is common in breast cancer survivors (BCS), affecting an estimated 30-50% of the 3.8 million BCS in the US. Insomnia is associated with health consequences for cardiometabolic and immune systems, neurobehavioral function, depression, fatigue, and quality of life and may put BCS at particular risk. While pharmacotherapy for insomnia may address symptoms in the short-term, cognitive behavioral therapy for insomnia (CBT-I) is considered the gold standard insomnia treatment. We describe our protocol to determine the efficacy of voice-activated delivery of CBT-I components on insomnia symptoms compared to a sleep education control among BCS.
Pilot randomized controlled trial of eHealth cognitive-behavioral therapy for insomnia among Spanish-speaking breast cancer survivors. [2023]Cognitive-Behavioral Therapy for Insomnia (CBT-I) is the gold-standard treatment for insomnia, which is common among breast cancer survivors (BCS). This pilot randomized controlled trial tested the first CBT-I intervention for Spanish-speaking BCS delivered using eHealth. Participants (N = 30) were Spanish-speaking BCS with insomnia symptoms recruited in Puerto Rico and randomized to a 6-week eHealth CBT-I group intervention or a waitlist control. Primary outcomes were acceptability (recruitment, treatment satisfaction) and feasibility (retention, attendance). Secondary outcomes were group differences in sleep outcomes post-treatment (i.e., insomnia symptoms, sleep disturbance, sleep efficiency). Recruitment (95%) and retention (97%) were excellent. All CBT-I participants (100%) attended ≥ 3 of 6 sessions. Satisfaction with CBT-I was acceptable. Post-intervention, there were medium to large group differences for average insomnia symptoms (d = 1.02), sleep disturbance (d = 1.25), and sleep efficiency (d = 0.77) favoring CBT-I. There were small/medium to medium/large group differences for the proportion of participants with clinically significant insomnia symptoms (d = 0.52), sleep disturbance (d = 0.67), and low sleep efficiency (d = 0.33) favoring CBT-I. Spanish-language eHealth CBT-I for BCS was acceptable and feasible and showed preliminary efficacy.ClinicalTrials.gov TRN: NCT04101526 (Posted September 24, 2019).
Solriamfetol Titration and AdministRaTion (START) in Patients with Obstructive Sleep Apnea: A Retrospective Chart Review and Hypothetical Patient Scenario. [2022]Solriamfetol (Sunosi™), a dopamine/norepinephrine reuptake inhibitor, is approved (USA and EU) to treat excessive daytime sleepiness (EDS) in adults with obstructive sleep apnea (OSA) (37.5-150 mg/day). Real-world research on solriamfetol initiation is limited. The objective of this study was to describe dosing and titration strategies used when initiating solriamfetol and to assess whether and how patient factors affected these strategies.
Solriamfetol for the Management of Excessive Daytime Sleepiness. [2022]To review efficacy, safety, and place in therapy of solriamfetol for management of excessive daytime sleepiness (EDS) in patients with narcolepsy and obstructive sleep apnea (OSA).
Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea. [2021]To evaluate long-term safety and maintenance of efficacy of solriamfetol treatment for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea (OSA).
Solriamfetol for the treatment of daytime sleepiness in obstructive sleep apnea. [2020]Introduction: Obstructive sleep apnea (OSA) is highly prevalent and constitutes a major health hazard. Current pharmacotherapy is ineffective in correcting sleep-disordered breathing and is used adjunctively to address residual sleepiness. A new drug, solriamfetol, a selective norepinephrine-dopamine reuptake inhibitor, is the first drug of its class that is being considered by the US Food and Drug Administration (FDA) to treat excessive sleepiness in OSA and narcolepsy patients. Areas covered: This review covers drug chemistry, pharmacodynamics, pharmacokinetics, and metabolism of solriamfetol. Results of three Phase 3 trials, Treatment of OSA and Narcolepsy Excessive Sleepiness (TONES 3, 4, 5), relevant to OSA patients are summarized. Published abstracts/articles and a 2017 Jazz Investor Presentation provided data. Databases searched included PubMed, Google Scholar, Lexi-Comp, Scopus, Science, and Ovid. Expert commentary: Solriamfetol shows promise as adjunctive therapy in OSA. It is well tolerated and effective in reducing sleepiness and is an alternative to modafinil or armodafinil. Unlike stimulants like methylphenidate or dextroamphetamine, it does not have cardiac effects, rebound hypersomnia, or withdrawal effects.
Solriamfetol for the treatment of excessive daytime sleepiness associated with narcolepsy. [2020]Introduction: Narcolepsy is a chronic disabling condition, excessive daytime somnolence is the main symptoms of it. There is currently no cure for narcolepsy, and hence there is a great need for new treatment options. Solriamfetol is a new selective dopamine and norepinephrine reuptake inhibitor with robust wake-promoting effects. The purpose of this paper is to review solriamfetol. Areas covered: The chemical property, mechanism of action, pharmacokinetics, clinical efficacy, and safety of solriamfetol are introduced in this paper. Expert opinion: Solriamfetol can bind to dopamine and norepinephrine transporters and inhibit reuptake of dopamine and norepinephrine. Clinical trials showed that solriamfetol could significantly improve the ability to stay awake and subjective symptoms of excessive sleepiness in adults with narcolepsy. Solriamfetol was well tolerated. Very common adverse reactions were headache, nausea, decreased appetite, insomnia, and anxiety.
Solriamfetol: First Global Approval. [2020]Solriamfetol (Sunosi™) is an orally active, selective dopamine and norepinephrine reuptake inhibitor that was recently approved in the USA as a treatment for excessive daytime sleepiness (hypersomnia) associated with narcolepsy and obstructive sleep apnoea (OSA). Norepinephrine and dopamine influence various physiologic functions, including sleep-wake regulation, and excessive sleepiness has been linked with dysregulation of dopaminergic and norepinephrine systems. This article summarizes the milestones in the development of solriamfetol leading to this first approval as a treatment for excessive daytime sleepiness associated with narcolepsy and OSA.
Efficacy and safety of solriamfetol for excessive sleepiness in narcolepsy and obstructive sleep apnea: findings from randomized controlled trials. [2021]Solriamfetol is developed for the treatment of excessive sleepiness in adult patients with narcolepsy and obstructive sleep apnea (OSA). No systematic review of existing literature has been investigated before. Therefore, the meta-analysis is conducted to assess the efficacy and safety of solriamfetol for excessive sleepiness in narcolepsy and OSA.
Clinically relevant effects of solriamfetol on excessive daytime sleepiness: a posthoc analysis of the magnitude of change in clinical trials in adults with narcolepsy or obstructive sleep apnea. [2022]To evaluate the clinical relevance of solriamfetol in treating excessive daytime sleepiness in participants with narcolepsy or obstructive sleep apnea (OSA).