Rankings / Cognitive

Solriamfetol (Sunosi)

Cognitive · DNRI / wakefulness-promoting

Tier B

Reviewed by Read Off Label · Last reviewed · How we grade

dopaminednriadhdcontrolled-substanceprescription
6.8 / 10
Tier B
Ev 8 Bn 8 Sf 5

Bottom line

Read Off Label grades Solriamfetol (Sunosi) as B (6.8/10) based on strong evidence, strong benefit magnitude, and a med-risk safety profile.

Originally developed by Aerial BioPharma and Jazz Pharmaceuticals; **Axsome Therapeutics acquired Sunosi from Jazz in March 2022** and now drives the development program.

Studied, labeled, or reported-use context: 75-150 mg PO once daily (FOCUS Ph3 300 mg dose was numerically superior but NOT statistically… — Rx; not individualized guidance.

What the evidence says

Originally developed by Aerial BioPharma and Jazz Pharmaceuticals; **Axsome Therapeutics acquired Sunosi from Jazz in March 2022** and now drives the development program. Distinguishing pharmacology vs modafinil: direct dopamine + norepinephrine reuptake inhibition (closer to a mild amphetamine than to modafinil); preclinical mouse data show comparable wake-promotion but less anxiety-related behavior and lower locomotor activation than modafinil at equivalent wake-promoting doses. **Major 2025 development**: FOCUS Phase 3 in adult ADHD (Axsome press release March 25 2025) met primary endpoint at 150 mg (AISRS reduction -17.7 vs placebo -14.3; statistically significant; 53.5% response rate vs 41.3% placebo). Axsome announced sNDA preparation for the ADHD indication. SUSTAIN Phase 3 in shift work disorder ongoing with topline expected 2026. **Cardiovascular caveat**: dose-related SBP/DBP increases at peak (~2 hr post-dose) are transient across 24 hr at 150 mg/day, but the indicated populations all carry elevated baseline CV risk — small chronic BP elevations are clinically meaningful for MACE risk. 2024 FAERS retrospective pharmacovigilance (Q3 2019 – Q1 2024) identified 30 disproportionality signals; AE profile consistent with label. Real-world preference: in a 62-patient retrospective, 71% of patients preferred solriamfetol over modafinil/armodafinil after switching; 29% reverted. Distinct from Pitolisant (Wakix) — the only non-scheduled wakefulness Rx — see adjacent row.

Mechanism

Selective dopamine and norepinephrine reuptake inhibitor (DNRI); mechanistically distinct from modafinil's adenosine/orexin pathway; FDA-approved 2019 for excessive daytime sleepiness in narcolepsy and OSA; March 2025 FOCUS Phase 3 also positive in adult ADHD

Studied, labeled, or reported dose & route

75-150 mg PO once daily (FOCUS Ph3 300 mg dose was numerically superior but NOT statistically significant on primary)

This records doses and routes described in studies, approved labeling, clinical practice, or documented use. It is not individualized guidance and does not establish safety; context changes with indication, formulation, health history, monitoring, and other medicines.

Citations

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Common questions

What does the evidence show about Solriamfetol (Sunosi)'s effects?
Read Off Label rates the evidence for Solriamfetol (Sunosi) as Strong and the benefit magnitude as strong, producing an overall grade of B (6.8/10). Originally developed by Aerial BioPharma and Jazz Pharmaceuticals; **Axsome Therapeutics acquired Sunosi from Jazz in March 2022** and now drives the development program.
What safety findings are reported for Solriamfetol (Sunosi)?
Solriamfetol (Sunosi) has a med risk profile in the database. Med (dose-related BP/HR elevation — meaningful given OSA/narcolepsy/ADHD populations carry elevated baseline CV risk; headache, anxiety, decreased appetite, insomnia all confirmed in 2024 FAERS pharmacovigilance; Schedule IV abuse potential) Legal status: Rx (Schedule IV US).
What doses or routes are reported for Solriamfetol (Sunosi)?
75-150 mg PO once daily (FOCUS Ph3 300 mg dose was numerically superior but NOT statistically significant on primary) This is context from studies, approved labeling, clinical practice, or documented use; it is not individualized guidance and does not establish safety.
How does Solriamfetol (Sunosi) work?
Selective dopamine and norepinephrine reuptake inhibitor (DNRI); mechanistically distinct from modafinil's adenosine/orexin pathway; FDA-approved 2019 for excessive daytime sleepiness in narcolepsy and OSA; March 2025 FOCUS Phase 3 also positive in adult ADHD

This is an independent synthesis of published research by a non-clinician. Scores are opinions supported by citations, not prescriptions. See the full disclaimer and methodology for how this score was produced and what it does and doesn't mean.