Solriamfetol
| Evidence Level: L2 | Predicted Indications: 10 |
Table of Contents
Solriamfetol: Attention deficit-hyperactivity disorder
Note: the page language is English, so the disease name is written once without parentheses: Solriamfetol: dopamine and norepinephrine reuptake inhibitor → attention deficit-hyperactivity disorder
One-Sentence Summary
Solriamfetol is a wake-promoting dopamine and norepinephrine reuptake inhibitor marketed in Canada as SUNOSI. The TxGNN model predicts it may be effective for attention deficit-hyperactivity disorder, with 5 clinical trials and 6 publications currently supporting this direction, at evidence level L2.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Attention deficit-hyperactivity disorder |
| TxGNN Prediction Score | 0.9999 |
| Evidence Level | L2 |
| Canada Market Status | Marketed (marketed DINs: 2 of 2) |
| Number of DINs | 2 (marketed: 2) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on general pharmacological knowledge, solriamfetol inhibits the reuptake of dopamine and norepinephrine. Stronger catecholamine signalling in prefrontal circuits is the established basis of ADHD treatment, as with methylphenidate and atomoxetine. This mechanism should be verified against primary sources.
The link is therefore direct and plausible: a drug that raises dopamine and norepinephrine activity targets the same pathways as current ADHD medicines. Solriamfetol also acts on a different profile from classic stimulants, which makes it of interest for people who do not tolerate or respond adequately to existing treatments.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT05972044 | Phase 3 | Completed | 516 | FOCUS: randomized, double-blind, placebo-controlled trial in adults with ADHD; results should be reviewed to confirm efficacy and safety |
| NCT04839562 | Phase 2/3 | Completed | 66 | Double-blind, placebo-controlled pilot in adults aged 18–65 with ADHD; consistent with PMID 37819836 |
| NCT07717892 | Phase 3 | Recruiting | 468 | 6-week placebo-controlled trial in adolescents aged 12 to <18 years; no results yet |
| NCT07717879 | Phase 3 | Recruiting | 468 | 6-week placebo-controlled trial in children aged 6 to <12 years; no results yet |
| NCT07773883 | Phase 3 | Enrolling by invitation | 300 | Open-label long-term safety study in children and adolescents; no results yet |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 37819836 | 2023 | RCT | The Journal of Clinical Psychiatry | Remote, randomized, double-blind, placebo-controlled 6-week dose-optimization pilot (75 or 150 mg) in adults with ADHD, examining effects and tolerability |
| 40986064 | 2025 | Review | Expert Opinion on Pharmacotherapy | Review of Phase III trials of potential new ADHD treatments, for patients who respond partially to or cannot tolerate current drugs |
| 38771653 | 2024 | Review | Expert Opinion on Pharmacotherapy | Recent advances in ADHD drug treatment beyond stimulants, which carry misuse and dependence risks |
| 41621729 | 2026 | Review | Pharmacology & Therapeutics | Overview of pharmacological, neuromodulatory and psychotherapeutic options for adult ADHD |
| 33870884 | 2022 | Review | CNS Spectrums | Commentary on solriamfetol for ADHD |
| 34534876 | 2021 | Review | Epilepsy & Behavior | Drugs for epilepsy with excessive daytime sleepiness; ADHD is mentioned as a comorbid condition |
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02515814 | SUNOSI | Not specified | Not specified |
| 02515822 | SUNOSI | Not specified | Not specified |
Safety Considerations
- Drug Interactions: 35 interactions were identified in total. One is rated Major: methylene blue. Most others are rated Moderate and involve adrenergic agents, including epinephrine, ephedrine, pseudoephedrine, phenylephrine, isometheptene, mazindol, and beta-agonists such as salbutamol, formoterol, olodaterol and vilanterol.
- Cardiovascular considerations: Possible effects on blood pressure and heart rate call for monitoring in any new population.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: The main prediction is supported by a completed Phase 3 placebo-controlled trial in adults (NCT05972044) and a completed Phase 2/3 pilot (NCT04839562, PMID 37819836), which places evidence at L2. The paediatric Phase 3 trials are still recruiting, so there is not yet a body of multiple completed Phase 3 trials.
To proceed, the following is needed:
- Review of the reported results from NCT05972044 and the published pilot to confirm efficacy and safety
- Package insert warnings and contraindications from Health Canada
- Verified mechanism of action data from primary sources
- Results from the paediatric Phase 3 trials and the long-term safety study before considering younger populations
- Cardiovascular and interaction monitoring plan, especially with adrenergic agents and methylene blue
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.