Solriamfetol for Shift Work Disorder
Recruiting in Palo Alto (17 mi)
+21 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Axsome Therapeutics, Inc.
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
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).
Is the drug Solriamfetol a promising treatment for Shift Work Disorder?Yes, Solriamfetol is a promising treatment for Shift Work Disorder because it can help people stay awake and alert during their work hours, improving their ability to perform tasks effectively.123813
What safety data exists for Solriamfetol?Solriamfetol, also known as Sunosi, has been evaluated for safety in several studies. It is approved in the US and EU for treating excessive daytime sleepiness in conditions like narcolepsy and obstructive sleep apnea. Clinical trials, including phase III studies, have shown that Solriamfetol has a consistent safety and tolerability profile. Common adverse reactions typically occur within the first two weeks of treatment and often resolve within the same period. The drug's safety has been supported by both clinical and real-world studies.1011121415
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the idea that Solriamfetol for Shift Work Disorder is an effective drug?The available research does not provide specific data on Solriamfetol for treating Shift Work Disorder. Instead, it focuses on another drug, armodafinil, which has been shown to help people with this condition by reducing sleepiness and improving alertness during work shifts. This suggests that similar drugs might also be effective, but there is no direct evidence for Solriamfetol in the provided information.45679
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
I am between 18 and 65 years old.
Exclusion Criteria
I have previously taken solriamfetol/Sunosi.
Participant Groups
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.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Solriamfetol 300mgExperimental Treatment1 Intervention
Up to 12 weeks
Group II: Solriamfetol 150mgExperimental Treatment1 Intervention
Up to 12 weeks
Group III: PlaceboPlacebo Group1 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Clinical Research SiteChula Vista, CA
Clinical Research SiteStockbridge, GA
Clinical Research SiteCincinnati, OH
Clinical Research SiteColumbia, SC
More Trial Locations
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Who is running the clinical trial?
Axsome Therapeutics, Inc.Lead Sponsor
References
Effects of changing the pattern of sickness absence referrals in a local authority. [2019]The high costs of sickness absence in North Tyneside Metropolitan Borough Council prompted a review of the system of referral of cases of long-term sickness absence to their occupational health service for opinion about fitness to work. Earlier and more consistent referral of these employees produced reductions in average lengths of sickness absence. Time off before medical retirement was reduced from 72 weeks to 53 weeks, and time off before returning to work was reduced from 40 weeks to 25 weeks. Exact figures of the financial savings could not be calculated, but the estimated saving was 760,000 pounds in the first year. Although the occupational health service was not responsible for the whole of this saving, it played an important role in the exercise. It was concluded that earlier referral of employees with long-term sickness absence enabled decisions about returning to work to be made sooner, thus saving large amounts of money.
An occupational health intervention programme for workers at high risk for sickness absence. Cost effectiveness analysis based on a randomised controlled trial. [2021]To determine whether, from a healthcare perspective, a specific occupational health intervention is cost effective in reducing sickness absence when compared with usual care in occupational health in workers with high risk of sickness absence.
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]In the past decade in activities aiming at return-to-work (RTW), there has been a growing awareness to change the focus from sickness and work disability to recovery and work ability. To date, this process in occupational health care (OHC) has mainly been directed towards employees. However, within the working population there are two vulnerable groups: temporary agency workers and unemployed workers, since they have no workplace/employer to return to, when sick-listed. For this group there is a need for tailored RTW strategies and interventions. Therefore, this paper aims to describe the structured and stepwise process of development, implementation and evaluation of a theory- and practise-based participatory RTW program for temporary agency workers and unemployed workers, sick-listed due to musculoskeletal disorders (MSD). This program is based on the already developed and cost-effective RTW program for employees, sick-listed due to low back pain.
Is shift work making your patient sick? Emerging theories and therapies for treating shift work disorder. [2011]"Shift work" is a term that applies to a wide array of nontraditional work schedules. Shift work disorder (SWD) is a circadian rhythm sleep disorder experienced by a subset of shift workers that is characterized by excessive sleepiness during work and/or insomnia during scheduled sleep times. It is estimated to affect up to 2 million Americans, and is associated with increased morbidity and mortality from metabolic risk factors, cardiovascular and gastrointestinal diseases, depression, accidents, and some kinds of cancers. Patient history is all that is needed to make a diagnosis with the International Classification of Sleep Disorders-Second Edition criteria as described herein. Circadian rhythm disorders, in which an underlying misalignment of circadian rhythm with the sleep-wake cycle occurs, may be treated by behavioral and pharmacologic approaches, including the use of hypnotics to improve the duration of sleep. However, evidence is limited with these approaches in patients diagnosed with SWD. Other treatment options may include pharmacologic interventions such as modafinil and armodafinil, which have shown efficacy in this population. Combined therapy can reduce insomnia and excessive sleepiness, and improve attention and alertness during work shifts and the subsequent commute home.
Efficacy and tolerability of armodafinil: effect on clinical condition late in the shift and overall functioning of patients with excessive sleepiness associated with shift work disorder. [2018]This study examined the effect of armodafinil on late-in-shift clinical condition, wakefulness, and overall functioning of patients with shift work disorder.
The effect of armodafinil on patient-reported functioning and quality of life in patients with excessive sleepiness associated with shift work disorder: a randomized, double-blind, placebo-controlled trial. [2021]To examine whether treatment with armodafinil for 6 weeks affected patient-reported overall functioning and daily quality of life compared with placebo in patients with excessive sleepiness associated with shift work disorder.
The impact of shift duration on the efficacy and tolerability of armodafinil in patients with excessive sleepiness associated with shift work disorder. [2018]To examine the impact of night-shift duration (≤9 hours or >9 hours) on efficacy and tolerability of armodafinil in patients with shift work disorder (SWD).
Sustaining Work Participation Across the Life Course. [2022]Introduction Many disability prevention strategies are focused on acute injuries and brief illness episodes, but there will be growing challenges for employers to manage circumstances of recurrent, chronic, or fluctuating symptoms in an aging workforce. The goal of this article is to summarize existing peer-review research in this area, compare this with employer discourse in the grey literature, and recommend future research priorities. Methods The authors participated in a year-long sponsored collaboration that ultimately led to an invited 3-day conference, "Improving Research of Employer Practices to Prevent Disability", held October 14-16, 2015, in Hopkinton, Massachusetts, USA. The collaboration included a topical review of the scientific and industry literature, group discussion to identify key areas and challenges, drafting of initial documents, and feedback from peer researchers and a special panel of experts with employer experience. Results Cancer and mental illness were chosen as examples of chronic or recurring conditions that might challenge conventional workplace return-to-work practices. Workplace problems identified in the literature included fatigue, emotional exhaustion, poor supervisor and co-worker support, stigma, discrimination, and difficulties finding appropriate accommodations. Workplace intervention research is generally lacking, but there is preliminary support for improving workplace self-management strategies, collaborative problem-solving, and providing checklists and other tools for job accommodation, ideas echoed in the literature directed toward employers. Research might be improved by following workers from an earlier stage of developing workplace concerns. Conclusions Future research of work disability should focus on earlier identification of at-risk workers with chronic conditions, the use of more innovative and flexible accommodation strategies matched to specific functional losses, stronger integration of the workplace into on-going rehabilitation efforts, and a better understanding of stigma and other social factors at work.
Shift Work Disorder. [2020]Shift work and its negative consequences are becoming more relevant as the economy becomes increasing globalized. For many individuals, shift work serves as a significant biological and psychosocial challenge leading to Shift Work Disorder (SWD). Beyond the symptoms of sleep and excessive sleepiness, the range of consequences for health and daily functioning in those with SWD are reviewed, along with evidence-based recommendations for clinical management, including comprehensive clinical assessments and intervention strategies that target multiple domains through pharmacologic and nonpharmacologic methods. A review of important recent scientific and technological developments for assessment and intervention is also provided.
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]Excessive daytime sleepiness (EDS) is the inability to maintain wakefulness and alertness during the major waking episodes of the day, with sleep occurring unintentionally or at inappropriate times. Solriamfetol is a selective norepinephrine-dopamine reuptake inhibitor approved for EDS. This review was done to assess the efficacy and safety of solriamfetol in patients with EDS in narcolepsy or OSA.
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).
Solriamfetol for Excessive Daytime Sleepiness in Parkinson's Disease: Phase 2 Proof-of-Concept Trial. [2022]Solriamfetol is approved (US and EU) for excessive daytime sleepiness (EDS) in narcolepsy and obstructive sleep apnea.
Work-related support in clinical care for patients with a chronic disease: development of an intervention. [2023]Patients with a chronic disease are more vulnerable in the labor market, and work-related support in clinical care would enhance the timely support greatly needed in each phase of their working life. This paper describes the development of a generic stay-at-work intervention to provide work-related support in clinical care to patients with a chronic disease.
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: A Review in Excessive Daytime Sleepiness Associated with Narcolepsy and Obstructive Sleep Apnoea. [2023]Solriamfetol (SUNOSI®) is an oral selective dopamine and norepinephrine reuptake inhibitor approved in the EU and the USA for improving wakefulness in adults with excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnoea (OSA). In phase III studies, 12 weeks' therapy with solriamfetol within the recommended dosage range for narcolepsy (75 mg or 150 mg once daily) or OSA (37.5 mg, 75 mg or 150 mg once daily) provided early and sustained reductions in excessive sleepiness and improvements in wakefulness relative to placebo. These effects were generally sustained through 52 weeks. The drug's effectiveness in adults with EDS associated with narcolepsy is supported by results from real-world studies. Solriamfetol demonstrated a consistent safety and tolerability profile across clinical studies, with commonly reported adverse reactions generally occurring within 2 weeks of treatment initiation and mostly resolving within 2 weeks. Thus, solriamfetol represents a useful treatment option for adults with EDS associated with narcolepsy or OSA.