Solriamfetol for Shift Work Disorder

Recruiting at 21 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Axsome Therapeutics, Inc.

Disqualifiers: Prior solriamfetol exposure, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

520 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the drug Solriamfetol for treating shift work disorder?

Solriamfetol is effective in reducing excessive sleepiness in conditions like narcolepsy and obstructive sleep apnea, as shown in various studies. It helps people stay awake and alert, which might suggest it could also help those with shift work disorder who struggle with staying awake during non-traditional work hours. ^{1 2 3 4 5}

Is solriamfetol safe for humans?

Solriamfetol has been shown to have a consistent safety profile in clinical studies for excessive daytime sleepiness in conditions like narcolepsy and obstructive sleep apnea. Common side effects usually appear within the first two weeks of treatment and often resolve quickly. ^{1 5 6 7 8}

How does the drug Solriamfetol differ from other treatments for Shift Work Disorder?

Solriamfetol is unique because it works by increasing the levels of dopamine and norepinephrine (chemicals in the brain that help with alertness and wakefulness), making it different from other treatments that might not target these specific pathways. ^{9 10 11 12 13}

What is the purpose of this trial?

SUSTAIN (Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with excessive sleepiness associated with shift work disorder (SWD).

Eligibility Criteria

This trial is for adults with excessive sleepiness due to shift work disorder. Participants must meet certain health standards, but specific inclusion and exclusion criteria are not detailed here.

Inclusion Criteria

Meets International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria for Shift Work Disorder (SWD)

Provides written informed consent to participate in the study before the conduct of any study procedures

Exclusion Criteria

Unable to comply with study procedures

Medically inappropriate for study participation in the opinion of the investigator.

I have previously taken solriamfetol/Sunosi.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive solriamfetol or placebo once per night shift for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Solriamfetol

Trial Overview The SUSTAIN study tests the effects of Solriamfetol at two different doses (150 mg and 300 mg) compared to a placebo in managing sleepiness related to shift work. It's a Phase 3 trial where participants are randomly assigned to one of these groups without knowing which one they're in.

Participant Groups

Group I: Solriamfetol 300mg Experimental Treatment 1 Intervention

Up to 12 weeks

Group II: Solriamfetol 150mg Experimental Treatment 1 Intervention

Up to 12 weeks

Group III: Placebo Placebo Group 1 Intervention

Up to 12 weeks

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

Who Is Running the Clinical Trial?

Axsome Therapeutics, Inc.

Lead Sponsor

Trials

34

Recruited

11,600+

Findings from Research

In a 4-week phase 2 trial involving adults with Parkinson's disease and excessive daytime sleepiness, solriamfetol was found to be safe and well-tolerated, with common side effects including nausea and dizziness.

While there were no significant improvements in the Epworth Sleepiness Scale, solriamfetol showed a dose-dependent increase in the Maintenance of Wakefulness Test, suggesting it may help improve alertness in patients with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Solriamfetol for Excessive Daytime Sleepiness in Parkinson's Disease: Phase 2 Proof-of-Concept Trial. Videnovic, A., Amara, AW., Comella, C., et al.[2022]

Solriamfetol significantly improves excessive sleepiness in adults with narcolepsy and obstructive sleep apnea, as evidenced by increased mean sleep latency and reduced Epworth Sleepiness Scale scores in a meta-analysis of 1177 patients from five randomized controlled trials.

While solriamfetol is effective, it is associated with a higher risk of adverse events compared to placebo, although the risk of serious adverse events is not significantly different between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of solriamfetol for excessive sleepiness in narcolepsy and obstructive sleep apnea: findings from randomized controlled trials. Wang, J., Yang, S., Li, X., et al.[2021]

Solriamfetol significantly improved wakefulness in adults with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA), showing effectiveness regardless of whether participants adhered to their primary OSA therapy.

The study, which included 459 participants over 12 weeks, found that solriamfetol did not affect the use of primary OSA therapy, indicating it can be safely used alongside existing treatments without altering their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of Solriamfetol for Excessive Daytime Sleepiness in OSA: An Analysis of Subgroups Adherent or Nonadherent to OSA Treatment. Schweitzer, PK., Mayer, G., Rosenberg, R., et al.[2021]

Solriamfetol is an effective first-line treatment for excessive sleepiness in patients with obstructive sleep apnea (OSA) and narcolepsy, approved by both the FDA and EMA, showing significant improvements in wakefulness and reduced sleepiness compared to placebo.

The drug works by selectively inhibiting the reuptake of dopamine and norepinephrine, and clinical trials demonstrated its efficacy through improved maintenance of wakefulness and lower scores on the Epworth Sleepiness Scale, indicating its potential as an initial or add-on therapy for patients not fully controlled by other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Profile of Solriamfetol in the Management of Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea: Focus on Patient Selection and Perspectives. Abad, VC.[2021]

In a study involving 50 patients with obstructive sleep apnea (OSA), most physicians initiated solriamfetol at doses of 37.5 or 75 mg/day, with many patients adjusting to stable doses of 75 or 150 mg/day within a median of 14 days.

The primary reason for initiating solriamfetol was the need for better efficacy in managing excessive daytime sleepiness, and most patients (96%) remained stable on the medication at the time of data collection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Solriamfetol Titration and AdministRaTion (START) in Patients with Obstructive Sleep Apnea: A Retrospective Chart Review and Hypothetical Patient Scenario. Singh, H., Hyman, D., Parks, GS., et al.[2022]

Solriamfetol has been shown to significantly improve wakefulness in patients with narcolepsy and obstructive sleep apnea, with improvements of 7.65 to 10.14 minutes in narcolepsy and 4.5 to 12.8 minutes in OSA compared to placebo, based on data from 6 clinical trials involving both phase II and phase III studies.

The medication has a favorable safety profile, with fewer adverse effects and a lower risk of drug interactions compared to other treatments for excessive daytime sleepiness, making it a viable option for patients with narcolepsy and OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Solriamfetol for the Management of Excessive Daytime Sleepiness. Cuomo, MC., Sheehan, AH., Jordan, JK.[2022]

Solriamfetol significantly improves wakefulness in patients with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA), showing a mean increase of nearly 10 minutes in the maintenance of wakefulness test compared to placebo.

The safety profile of solriamfetol is favorable, with common side effects including headache and nausea, but it remains well tolerated, making it a recommended treatment option for EDS in these patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of solriamfetol for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea: a systematic review and meta-analysis of clinical trials. Subedi, R., Singh, R., Thakur, RK., et al.[2021]

Solriamfetol (SUNOSI®) is effective in improving wakefulness in adults with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnoea, showing significant reductions in sleepiness after 12 weeks of treatment in phase III studies with dosages of 37.5 mg to 150 mg once daily.

The drug has a consistent safety profile, with common side effects appearing within the first two weeks and typically resolving quickly, making it a viable treatment option for managing EDS in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Solriamfetol: A Review in Excessive Daytime Sleepiness Associated with Narcolepsy and Obstructive Sleep Apnoea. Hoy, SM.[2023]

Implementing earlier and more consistent referrals to the occupational health service for employees with long-term sickness absence led to a significant reduction in average sickness absence durations, with time off before medical retirement decreasing from 72 weeks to 53 weeks.

The estimated financial savings from this intervention were around £760,000 in the first year, highlighting the economic benefits of timely medical assessments in managing long-term sickness absence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of changing the pattern of sickness absence referrals in a local authority. Malcolm, RM., Harrison, J., Forster, H.[2019]

A new return-to-work (RTW) program has been developed specifically for temporary agency workers and unemployed individuals with musculoskeletal disorders, focusing on their unique challenges since they lack a workplace to return to.

The program uses a structured approach involving stakeholder participation and the Attitude-Social influence-self-Efficacy (ASE) model to identify obstacles and create tailored solutions, with plans for evaluation through a randomized controlled trial to assess its cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention mapping for development of a participatory return-to-work intervention for temporary agency workers and unemployed workers sick-listed due to musculoskeletal disorders. Vermeulen, SJ., Anema, JR., Schellart, AJ., et al.[2021]

The article emphasizes the need for better management of chronic conditions like cancer and mental illness in the workplace, highlighting issues such as fatigue, stigma, and lack of support that can hinder return-to-work practices.

Future research should focus on early identification of at-risk workers and innovative accommodation strategies to better support employees with chronic conditions, integrating workplace practices with ongoing rehabilitation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustaining Work Participation Across the Life Course. Pransky, GS., Fassier, JB., Besen, E., et al.[2022]

A specific occupational health intervention significantly reduced sickness absence days from an average of 30 days in the usual care group to 19 days in the intervention group, demonstrating its effectiveness in managing high-risk workers.

The intervention was also cost-effective, saving approximately €43 per sickness absence day avoided, indicating that it is a beneficial use of healthcare resources compared to usual occupational health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An occupational health intervention programme for workers at high risk for sickness absence. Cost effectiveness analysis based on a randomised controlled trial. Taimela, S., Justén, S., Aronen, P., et al.[2021]

A new stay-at-work intervention was developed to provide work-related support for patients with chronic diseases, emphasizing the need for behavioral change among healthcare professionals (HCPs) to improve patient outcomes.

The intervention includes a care pathway with screening and tailored support, along with practical tools and training for HCPs, making it adaptable to different healthcare settings while considering local resources and regulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Work-related support in clinical care for patients with a chronic disease: development of an intervention. Butink, M., Dona, D., Boonen, A., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Solriamfetol for Excessive Daytime Sleepiness in Parkinson's Disease: Phase 2 Proof-of-Concept Trial. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy and safety of solriamfetol for excessive sleepiness in narcolepsy and obstructive sleep apnea: findings from randomized controlled trials. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of Solriamfetol for Excessive Daytime Sleepiness in OSA: An Analysis of Subgroups Adherent or Nonadherent to OSA Treatment. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Profile of Solriamfetol in the Management of Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea: Focus on Patient Selection and Perspectives. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Solriamfetol Titration and AdministRaTion (START) in Patients with Obstructive Sleep Apnea: A Retrospective Chart Review and Hypothetical Patient Scenario. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Solriamfetol for the Management of Excessive Daytime Sleepiness. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy and safety of solriamfetol for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea: a systematic review and meta-analysis of clinical trials. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Solriamfetol: A Review in Excessive Daytime Sleepiness Associated with Narcolepsy and Obstructive Sleep Apnoea. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Effects of changing the pattern of sickness absence referrals in a local authority. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Intervention mapping for development of a participatory return-to-work intervention for temporary agency workers and unemployed workers sick-listed due to musculoskeletal disorders. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Sustaining Work Participation Across the Life Course. [2022]

12. England pubmed.ncbi.nlm.nih.gov

An occupational health intervention programme for workers at high risk for sickness absence. Cost effectiveness analysis based on a randomised controlled trial. [2021]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Work-related support in clinical care for patients with a chronic disease: development of an intervention. [2023]