Solriamfetol Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Solriamfetol comprises 12 peer-reviewed publications across 11 journals, 2 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Fatigue Syndrome, Chronic, Disorders of Excessive Somnolence, Attention Deficit Disorder with Hyperactivity, and Binge-Eating Disorder. Most recent publication: Solriamfetol for Excessive Sleepiness in Early-Morning Shift Work Disorder., NEJM Evid, 2026.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. Solriamfetol for Excessive Sleepiness in Early-Morning Shift Work Disorder.
    Zitting KM, Gilmore KR, Lockyer BJ, et al. · NEJM Evid · 2026
    PubMed: PMID 41590992 · NCT04788953 · Disorders of Excessive Somnolence
  2. Solriamfetol improves daily fatigue symptoms in adults with myalgic encephalomyelitis/chronic fatigue syndrome after 8 weeks of treatment.
    Young JL, Powell RN, Powell A, et al. · J Psychopharmacol · 2025
    PubMed: PMID 40958377 · NCT04622293 · Fatigue Syndrome, Chronic
  3. Results of the Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-Controlled Study (SHARP): A Randomized Placebo-Controlled Double-Blind Repeated-Measures Crossover Phase IV Clinical Trial of the Effect of the Wake-Promoting Agent Solriamfetol on Cognitive Function in OSA With Excessive Daytime Sleepiness and Cognitive Impairment.
    Van Dongen HPA, Leary EB, Drake C, et al. · Chest · 2025
    PubMed: PMID 39528111 · NCT04789174 (SHARP) · Disorders of Excessive Somnolence
  4. Solriamfetol for Attention-Deficit/Hyperactivity Disorder in Adults: A Double-Blind Placebo-Controlled Pilot Study.
    Surman CBH, Walsh DM, Horick N, et al. · J Clin Psychiatry · 2023
    PubMed: PMID 37819836 · NCT04839562 · Attention Deficit Disorder with Hyperactivity
  5. Study protocol and rationale for a randomized, placebo-controlled trial of solriamfetol to treat binge eating disorder.
    Guerdjikova AI, Romo-Nava F, Blom TJ, et al. · Contemp Clin Trials · 2021
    PubMed: PMID 34610482 · NCT04602936 · Binge-Eating Disorder
  6. Efficacy and Safety of Solriamfetol on Excessive Daytime Sleepiness Associated with Obstructive Sleep Apnea in China: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial.
    Cheng H, Deng L, Meng Z, et al. · CNS Drugs · 2026
    PubMed: PMID 41128833 · NCT06103825 · Disorders of Excessive Somnolence
  7. Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study.
    Strollo PJ, Hedner J, Collop N, et al. · Chest · 2019
    PubMed: PMID 30471270 · NCT04622293 · Fatigue Syndrome, Chronic
  8. The Fatigue Symptom Inventory: a systematic review of its psychometric properties.
    Donovan KA, Jacobsen PB · Support Care Cancer · 2011
    PubMed: PMID 20824482 · NCT04622293 · Fatigue Syndrome, Chronic

Primary-outcome results across pivotal trials

Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.

TrialIndicationPrimary endpointArmValue
NCT04839562Attention Deficit Disorder with HyperactivityA Priori Definition of Clinical Improvement
six weeks
Placebo2 Participants
Solriamfetol13 Participants
NCT04839562Attention Deficit Disorder with HyperactivityAdult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score
six weeks
Placebo-2.1 score on a scale
Solriamfetol-7.6 score on a scale

Publications by year

1998–2026: 12 publications.

1998
1
2003
1
2009
1
2011
2
2019
1
2021
1
2023
1
2025
2
2026
2

Publications by indication

Fatigue Syndrome, Chronic (7)

  • Solriamfetol improves daily fatigue symptoms in adults with myalgic encephalomyelitis/chronic fatigue syndrome after 8 weeks of treatment.
    J Psychopharmacol · 2025 · PMID 40958377 · NCT04622293
  • Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study.
    Chest · 2019 · PMID 30471270 · NCT04622293
  • The Fatigue Symptom Inventory: a systematic review of its psychometric properties.
    Support Care Cancer · 2011 · PMID 20824482 · NCT04622293
  • The clinical global impressions scale: applying a research tool in clinical practice.
    Psychiatry (Edgmont) · 2011 · PMID 20526405 · NCT04622293
  • Identifying clinically meaningful fatigue with the Fatigue Symptom Inventory.
    J Pain Symptom Manage · 2009 · PMID 18495413 · NCT04622293

Disorders of Excessive Somnolence (3)

  • Solriamfetol for Excessive Sleepiness in Early-Morning Shift Work Disorder.
    NEJM Evid · 2026 · PMID 41590992 · NCT04788953
  • Efficacy and Safety of Solriamfetol on Excessive Daytime Sleepiness Associated with Obstructive Sleep Apnea in China: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial.
    CNS Drugs · 2026 · PMID 41128833 · NCT06103825
  • Results of the Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-Controlled Study (SHARP): A Randomized Placebo-Controlled Double-Blind Repeated-Measures Crossover Phase IV Clinical Trial of the Effect of the Wake-Promoting Agent Solriamfetol on Cognitive Function in OSA With Excessive Daytime Sleepiness and Cognitive Impairment.
    Chest · 2025 · PMID 39528111 · NCT04789174

Attention Deficit Disorder with Hyperactivity (1)

  • Solriamfetol for Attention-Deficit/Hyperactivity Disorder in Adults: A Double-Blind Placebo-Controlled Pilot Study.
    J Clin Psychiatry · 2023 · PMID 37819836 · NCT04839562

Binge-Eating Disorder (1)

  • Study protocol and rationale for a randomized, placebo-controlled trial of solriamfetol to treat binge eating disorder.
    Contemp Clin Trials · 2021 · PMID 34610482 · NCT04602936

Publications by journal

Trial-results highlights

For individuals diagnosed with Attention Deficit Disorder with Hyperactivity, the six-week study NCT04839562 investigated the effects of Solriamfetol. One of the primary outcomes evaluated in this study was the A Priori Definition of Clinical Improvement. In the Solriamfetol arm of NCT04839562, 13 participants met the A Priori Definition of Clinical Improvement. Separately, the placebo arm in NCT04839562 reported 2 participants meeting the A Priori Definition of Clinical Improvement.

Another key primary outcome assessed in the six-week study NCT04839562, which focused on Attention Deficit Disorder with Hyperactivity, was the Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score. The Solriamfetol arm in NCT04839562 reported a mean score of -7.6 on the Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score. In contrast, the placebo arm within NCT04839562 reported a mean score of -2.1 on the Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score.

All values are sourced from primary registry reporting, and individual papers should be consulted for clinical decisions.

All Solriamfetol publications (12)

2026 (2 papers)

  1. Solriamfetol for Excessive Sleepiness in Early-Morning Shift Work Disorder.
    Zitting KM, Gilmore KR, Lockyer BJ, et al. · NEJM Evid · 2026 · Derived
    PubMed: PMID 41590992 · NCT04788953 · Disorders of Excessive Somnolence
  2. Efficacy and Safety of Solriamfetol on Excessive Daytime Sleepiness Associated with Obstructive Sleep Apnea in China: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial.
    Cheng H, Deng L, Meng Z, et al. · CNS Drugs · 2026 · Derived
    PubMed: PMID 41128833 · NCT06103825 · Disorders of Excessive Somnolence

2025 (2 papers)

  1. Solriamfetol improves daily fatigue symptoms in adults with myalgic encephalomyelitis/chronic fatigue syndrome after 8 weeks of treatment.
    Young JL, Powell RN, Powell A, et al. · J Psychopharmacol · 2025 · Derived
    PubMed: PMID 40958377 · NCT04622293 · Fatigue Syndrome, Chronic
  2. Results of the Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-Controlled Study (SHARP): A Randomized Placebo-Controlled Double-Blind Repeated-Measures Crossover Phase IV Clinical Trial of the Effect of the Wake-Promoting Agent Solriamfetol on Cognitive Function in OSA With Excessive Daytime Sleepiness and Cognitive Impairment.
    Van Dongen HPA, Leary EB, Drake C, et al. · Chest · 2025 · Derived
    PubMed: PMID 39528111 · NCT04789174 (SHARP) · Disorders of Excessive Somnolence

2023 (1 paper)

  1. Solriamfetol for Attention-Deficit/Hyperactivity Disorder in Adults: A Double-Blind Placebo-Controlled Pilot Study.
    Surman CBH, Walsh DM, Horick N, et al. · J Clin Psychiatry · 2023 · Derived
    PubMed: PMID 37819836 · NCT04839562 · Attention Deficit Disorder with Hyperactivity

2021 (1 paper)

  1. Study protocol and rationale for a randomized, placebo-controlled trial of solriamfetol to treat binge eating disorder.
    Guerdjikova AI, Romo-Nava F, Blom TJ, et al. · Contemp Clin Trials · 2021 · Derived
    PubMed: PMID 34610482 · NCT04602936 · Binge-Eating Disorder

2019 (1 paper)

  1. Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study.
    Strollo PJ, Hedner J, Collop N, et al. · Chest · 2019 · Background
    PubMed: PMID 30471270 · NCT04622293 · Fatigue Syndrome, Chronic

2011 (2 papers)

  1. The Fatigue Symptom Inventory: a systematic review of its psychometric properties.
    Donovan KA, Jacobsen PB · Support Care Cancer · 2011 · Background
    PubMed: PMID 20824482 · NCT04622293 · Fatigue Syndrome, Chronic
  2. The clinical global impressions scale: applying a research tool in clinical practice.
    Busner J, Targum SD · Psychiatry (Edgmont) · 2011 · Background
    PubMed: PMID 20526405 · NCT04622293 · Fatigue Syndrome, Chronic

2009 (1 paper)

  1. Identifying clinically meaningful fatigue with the Fatigue Symptom Inventory.
    Donovan KA, Jacobsen PB, Small BJ, et al. · J Pain Symptom Manage · 2009 · Background
    PubMed: PMID 18495413 · NCT04622293 · Fatigue Syndrome, Chronic

2003 (1 paper)

  1. Validation of two global impression questionnaires for incontinence.
    Yalcin I, Bump RC · Am J Obstet Gynecol · 2003 · Background
    PubMed: PMID 12861145 · NCT04622293 · Fatigue Syndrome, Chronic

1998 (1 paper)

  1. Measurement of fatigue in cancer patients: development and validation of the Fatigue Symptom Inventory.
    Hann DM, Jacobsen PB, Azzarello LM, et al. · Qual Life Res · 1998 · Background
    PubMed: PMID 9610214 · NCT04622293 · Fatigue Syndrome, Chronic

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).