Solriamfetol for Shift Work Disorder

Recruiting at 38 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests solriamfetol, a medication that may reduce excessive sleepiness in adults with shift work disorder. Shift work disorder occurs when irregular hours, such as night shifts, cause difficulty staying awake at work or sleeping at home. Researchers will give some participants solriamfetol and others a placebo (a pill with no active medication) to determine which is more effective over 12 weeks. The trial seeks participants diagnosed with shift work disorder who experience significant sleepiness affecting their daily life. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that solriamfetol reduces sleepiness, particularly in night shift workers. One study found it significantly decreased both objective and subjective sleepiness compared to a placebo. People taking solriamfetol felt less sleepy and more alert.

Regarding safety, research suggests solriamfetol is generally well-tolerated. Clinical use has not reported major safety concerns. Some harmful effects occurred only at very high doses, which are not typically used in treatment. At the doses tested, the drug is considered safe for most people.

Solriamfetol is already approved for other uses, supporting its safety profile. It has been linked to improvements in work productivity and quality of life over the long term, indicating a positive overall impact on health. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for shift work disorder?

Unlike the standard treatments for Shift Work Disorder, which often include lifestyle changes and medications like modafinil or armodafinil, Solriamfetol offers a different approach. It works by targeting the dopamine and norepinephrine reuptake pathways, potentially improving wakefulness more effectively. Researchers are excited about Solriamfetol because it might provide a quicker onset of action and reduced side effects compared to existing options, offering a promising alternative for those who struggle with maintaining alertness during non-traditional work hours.

What evidence suggests that solriamfetol might be an effective treatment for shift work disorder?

Studies have shown that solriamfetol can greatly reduce sleepiness in people with shift work disorder. In this trial, participants will receive either solriamfetol at 150mg or 300mg, or a placebo. One study found that solriamfetol outperformed a placebo in reducing sleepiness and the severity of the condition. Research also shows that solriamfetol can improve quality of life and work performance for people with sleep problems, such as obstructive sleep apnea. These findings suggest that solriamfetol could be a promising option for managing excessive sleepiness. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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 (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]

Citations

1. academic.oup.com academic.oup.com/sleep/article/48/Supplement_1/A383/8135873

0881 Clinical Trial of Solriamfetol for Excessive Sleepiness ... Solriamfetol significantly improved objective and subjective sleepiness and reduced the severity of illness compared to placebo in participants ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7393785/

Effects of Solriamfetol on Quality-of-Life Measures from a ... Conclusions: Solriamfetol improved measures of functioning, quality of life, and work productivity in participants with obstructive sleep apnea and excessive ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04788953

Clinical Trial of Solriamfetol for Excessive Sleepiness ... In this clinical trial, the investigators will test whether Solriamfetol (SUNOSITM), a drug approved for the treatment of ES in patients with obstructive sleep ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0012369224054709

Results of the Solriamfetol's Effect on Cognitive Health in ... This study found that solriamfetol, compared with placebo, improved cognitive function in participants with cognitive impairment associated with OSA and ...

5. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.9384

Long-term effects of solriamfetol on quality of life and work ... Study Impact: Long-term solriamfetol treatment was associated with sustained improvements in functional status, work productivity, and quality of life for up ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8494093/

Long-term effects of solriamfetol on quality of life and work ... Study Impact: Long-term solriamfetol treatment was associated with sustained improvements in functional status, work productivity, and quality of life for up to ...

7. ema.europa.eu ema.europa.eu/en/documents/rmp/sunosi-epar-risk-management-plan_en.pdf

Sunosi, INN-solriamfetol - EMA No significant safety concerns for the clinical use of solriamfetol arose from toxicology studies. The principal toxicities noted at high doses of solriamfetol ...

8. journal.chestnet.org journal.chestnet.org/article/S0012-3692(24)05470-9/fulltext

Results of the Solriamfetol's Effect on Cognitive Health in ... Interpretation: This study found that solriamfetol, compared with placebo, improved cognitive function in participants with cognitive impairment ...