SUNOSI (solriamfetol hydrochloride)
Sunosi (solriamfetol) is indicated to improve wakefulness in adult patients with excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA). It is not a treatment for the underlying airway obstruction in OSA. For patients with OSA, primary treatment modalities (such as CPAP) must be utilized for at least one month prior to initiating Sunosi and must be continued during treatment. Sunosi is intended as an adjunct therapy and not a replacement for primary OSA treatments.
How SUNOSI Works
Solriamfetol is a dopamine and norepinephrine reuptake inhibitor (DNRI). While the precise mechanism by which it improves wakefulness in patients with narcolepsy or OSA is not fully established, its efficacy is thought to be mediated through its activity as a DNRI.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-03-20
- Patent Cliff
- 2042
- Routes
- ORAL
- Dosage Forms
- TABLET
SUNOSI Approval History
What SUNOSI Treats
2 indicationsSUNOSI is approved for 2 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Narcolepsy
- Obstructive Sleep Apnea
SUNOSI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in SUNOSI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SUNOSI treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to SUNOSI
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SUNOSI FDA Label Details
Indications & Usage
FDA Label (PDF)SUNOSI is indicated for the treatment of Narcolepsy; Obstructive Sleep Apnea.
SUNOSI Patents & Exclusivity
Patents (42 active)
Exclusivity
Pro Intelligence Preview
Deep insights for SUNOSI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2042
- • 162 active patents
Trial Analysis
- • 6 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment