Solriamfetol Clinical Trials (2026): 19 Studies for Obstructive Sleep Apnea & Excessive Sleepiness
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
Synced daily from ClinicalTrials.gov via AACT. Last sync: .
19 Solriamfetol clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 15 indications (including Obstructive Sleep Apnea & Excessive Sleepiness) and 6,310 total planned enrollment. 7 Phase 3 Solriamfetol trials and 4 Phase 2, 5 Phase 4 are listed. 7 Solriamfetol clinical trials are actively recruiting at 92 U.S. sites across 23 states. Most recent activity: NCT06413420 (Sep 2029).
Where to Participate: All Solriamfetol Trial Sites in the U.S. (92 sites across 23 states)
Every actively recruiting Solriamfetoltrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| AL | Clinical Research Site | Cullman35055 | NCT06568367 | Map |
| AZ | Clinical Research Site | Chandler85224 | NCT06568367 | Map |
| AZ | Clinical Research Site | Tucson85704 | NCT06568367 | Map |
| AR | Clinical Research Site | Little Rock72211 | NCT06568367 | Map |
| CA | Clinical Research Site | Cerritos90703 | NCT06568367 | Map |
| CA | Clinical Research Site | Chino91710 | NCT07484217 | Map |
| CA | Clinical Research Site | Chula Vista91910 | NCT06568367 | Map |
| CA | Clinical Research Site | Encino91316 | NCT06413433 | Map |
| CA | Clinical Research Site | Garden Grove92845 | NCT06413433 | Map |
| CA | Clinical Research Site | Huntington Beach92647 | NCT06568367 | Map |
| CA | Clinical Research Site | Long Beach90805 | NCT06568367 | Map |
| CA | Clinical Research Site | Long Beach90806 | NCT06413433 | Map |
| CA | Clinical Research Site | Newport Beach92660 | NCT06413433 | Map |
| CA | Clinical Research Site | Redlands92374 | NCT07484217 | Map |
| CA | Clinical Research Site | Santa Ana92705 | NCT06568367 | Map |
| CA | Clinical Research Site | Santa Ana92705 | NCT06413433 | Map |
| CA | Clinical Research Site | Walnut Creek94596 | NCT06413433 | Map |
| CA | Clinical Research Site | Walnut Creek94596 | NCT07484217 | Map |
| CA | Clinical Research Site | West Covina91790 | NCT06413433 | Map |
| CO | Clinical Research Site | Colorado Springs80918 | NCT06568367 | Map |
| CO | Clinical Research Site | Colorado Springs80910 | NCT06413433 | Map |
| CT | Clinical Research Site | Cromwell06416 | NCT06413433 | Map |
| FL | Clinical Research Site | Brandon33511 | NCT06568367 | Map |
| FL | Clinical Research Site | Fort Myers33912 | NCT06413433 | Map |
| FL | Clinical Research Site | Hialeah33016 | NCT06568367 | Map |
| FL | Clinical Research Site | Hialeah33012 | NCT06413433 | Map |
| FL | Clinical Research Site | Jacksonville32256 | NCT06413433 | Map |
| FL | Clinical Research Site | Jacksonville32256 | NCT07484217 | Map |
| FL | Clinical Research Site | Lauderhill33319 | NCT06413433 | Map |
| FL | Clinical Research Site | Miami33135 | NCT06568367 | Map |
| FL | Clinical Research Site | Miami33144 | NCT06568367 | Map |
| FL | Clinical Research Site | Miami33176 | NCT06568367 | Map |
| FL | Clinical Research Site | Miami33145 | NCT06413433 | Map |
| FL | Clinical Research Site | Miami33176 | NCT06413433 | Map |
| FL | Clinical Research Site | Miami33176 | NCT07484217 | Map |
| FL | Clinical Research Site | Miami Lakes33016 | NCT06568367 | Map |
| FL | Clinical Research Site | Orlando32801 | NCT06413433 | Map |
| GA | Clinical Research Site | Atlanta30238 | NCT06568367 | Map |
| GA | Clinical Research Site | Marietta30060 | NCT06413433 | Map |
| GA | Clinical Research Site | Stockbridge30281 | NCT06568367 | Map |
| KS | Clinical Research Site | Overland Park66210 | NCT06413433 | Map |
| MD | Johns Hopkins University | Baltimore21287 | NCT06170970 | Map |
| MD | Clinical Research Site | Towson21286 | NCT06568367 | Map |
| MA | Clinical Research Site | Boston02115 | NCT06568367 | Map |
| MA | Clinical Research Site | Boston02131 | NCT06413433 | Map |
| MI | Clinical Research Site | Lansing48911 | NCT06568367 | Map |
| MI | Clinical Research Site | Novi48377 | NCT06568367 | Map |
| MI | Clinical Research Site | Southfield48075 | NCT06568367 | Map |
| MO | Clinical Research Site | Chesterfield63017 | NCT06568367 | Map |
| MO | Clinical Research Site | Saint Charles63304 | NCT06413433 | Map |
| MO | Clinical Research Site | St Louis63123 | NCT06568367 | Map |
| NV | Clinical Research Site | Henderson89052 | NCT06568367 | Map |
| NJ | Clinical Research Site | Cherry Hill08002 | NCT06413433 | Map |
| NJ | Clinical Research Site | Cherry Hill08002 | NCT07484217 | Map |
| NJ | Clinical Research Site | Middletown07748 | NCT06568367 | Map |
| NJ | Clinical Research Site | Princeton08540 | NCT06413433 | Map |
| NJ | Clinical Research Site | Toms River08755 | NCT07484217 | Map |
| NY | Clinical Research Site | Brooklyn11235 | NCT07484217 | Map |
| NY | Clinical Research Site | Mount Kisco10549 | NCT06413433 | Map |
| NY | Clinical Research Site | New York10128 | NCT06413433 | Map |
| NY | Clinical Research Site | The Bronx10464 | NCT07484217 | Map |
| NC | Clinical Research Site | Denver28037 | NCT06568367 | Map |
| NC | Clinical Research Site | Fayetteville28304 | NCT06568367 | Map |
| NC | Clinical Research Site | Huntersville28078 | NCT06568367 | Map |
| NC | Evidera, a PPD business unit | Morrisville27560 | NCT06413420 | Map |
| NC | Clinical Research Site | Raleigh27607 | NCT06413433 | Map |
| NC | PPD, Inc. | Wilmington28401 | NCT06413420 | Map |
| OH | Clinical Research Site | Cincinnati45212 | NCT06568367 | Map |
| OH | Clinical Research Site | Cincinnati45245 | NCT06568367 | Map |
| OH | Clinical Research Site | Cincinnati45215 | NCT06413433 | Map |
| OH | Clinical Research Site | Cincinnati45215 | NCT07484217 | Map |
| OH | Clinical Research Site | Mason45040 | NCT06413433 | Map |
| OH | Clinical Research Site | Middleburg Heights44130 | NCT06413433 | Map |
| OR | Clinical Research Site | Portland97210 | NCT06413433 | Map |
| OR | Clinical Research Site | Portland97210 | NCT07484217 | Map |
| PA | Clinical Research Site | Allentown18104 | NCT06413433 | Map |
| PA | Clinical Research Site | Media19063 | NCT06413433 | Map |
| PA | Clinical Research Site | Wyomissing19610 | NCT06568367 | Map |
| SC | Clinical Research Site | Charleston29425 | NCT06568367 | Map |
| SC | Clinical Research Site | Columbia29201 | NCT06568367 | Map |
| SC | Clinical Research Site | Greenville29615 | NCT06413433 | Map |
| SC | Clinical Research Site | North Charleston29405 | NCT06413433 | Map |
| TN | Clinical Research Site | Memphis38119 | NCT06413433 | Map |
| TN | Clinical Research Site | Memphis38119 | NCT07484217 | Map |
| TX | Clinical Research Site | Austin73787 | NCT06413433 | Map |
| TX | Clinical Research Site | Austin78731 | NCT06413433 | Map |
| TX | Clinical Research Site | Dallas75231 | NCT06413433 | Map |
| TX | Clinical Research Site | Dallas75243 | NCT07484217 | Map |
| TX | Clinical Research Site | Houston77070 | NCT06568367 | Map |
| TX | Clinical Research Site | San Antonio78229 | NCT06568367 | Map |
| TX | Clinical Research Site | San Antonio78229 | NCT06413433 | Map |
| TX | Clinical Research Site | Sugar Land77478 | NCT06568367 | Map |
Solriamfetol clinical trials at a glance: phase × recruitment status
| Phase | recruiting | enrolling by invitation | completed | terminated | not yet recruiting | unknown | Total |
|---|---|---|---|---|---|---|---|
| P1 | 1 | 1 | |||||
| P2 | 1 | 2 | 1 | 4 | |||
| P2/P3 | 1 | 1 | |||||
| P3 | 3 | 1 | 3 | 7 | |||
| P4 | 3 | 1 | 1 | 5 | |||
| N/A | 1 | 1 |
Recruiting Solriamfetol clinical trials (7)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT06413420 | SUNOSI® (Solriamfetol) Pregnancy Registry | — | Narcolepsy | 1,731 | Jul 2019 |
| NCT07484217 | CLARITYClinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol | P3 | Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms | 508 | Feb 2026 |
| NCT06590662 | SOLR-IHEfficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia. | P2 | Idiopathic Hypersomnia | 60 | Sep 2024 |
| NCT06170970 | SOLARIMSSolriamfetol for the Treatment of Multiple Sclerosis Fatigue | P2 | Multiple Sclerosis | 46 | Jun 2024 |
| NCT06878976 | Open-Label Safety Study of Solriamfetol in Subjects With Binge Eating Disorder | P3 | Binge-Eating Disorder | 300 | Feb 2025 |
| NCT06568367 | SUSTAINStudying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN) | P3 | Excessive Sleepiness | 520 | Aug 2024 |
| NCT06413433 | ENGAGEElucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol | P3 | Binge-Eating Disorder | 450 | Apr 2024 |
Solriamfetol clinical trials by indication
Binge-Eating Disorder (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06878976 | — | P3 | enrolling by invitation | Open-Label Safety Study of Solriamfetol in Subjects With Binge Eating Disorder |
| NCT06413433 | ENGAGE | P3 | recruiting | Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol |
Long COVID (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06404099 | RECOVER-SLEEP | P2 | completed | RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia) |
| NCT06404086 | RECOVER-SLEEP | P2 | completed | RECOVER-SLEEP: Platform Protocol |
Excessive Sleepiness (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06568367 | SUSTAIN | P3 | recruiting | Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN) |
| NCT04788953 | — | P4 | terminated | Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder |
Narcolepsy (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06413420 | — | N/A | recruiting | SUNOSI® (Solriamfetol) Pregnancy Registry |
| NCT05008341 | — | P1 | completed | Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration |
Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07484217 | CLARITY | P3 | recruiting | Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol |
Idiopathic Hypersomnia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06590662 | SOLR-IH | P2 | not yet recruiting | Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia. |
Multiple Sclerosis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06170970 | SOLARIMS | P2 | recruiting | Solriamfetol for the Treatment of Multiple Sclerosis Fatigue |
Major Depressive Disorder (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06360419 | PARADIGM | P3 | completed | Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol |
Sleep Apnea, Obstructive (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06103825 | EDS | P3 | completed | A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Solriamfetol in the Treatment of Excessive Daytime Sleepiness (EDS) in Patients with Obstructive Sleep Apnea (OSA) |
Insomnia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05838430 | — | P4 | completed | Solriamfetol and CBT-I in Patients With Insomnia Disorder |
ADHD (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05972044 | FOCUS | P3 | completed | A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS) |
Attention Deficit Hyperactivity Disorder (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04839562 | ADHD | P2/P3 | completed | A Controlled Study of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD) in Adults |
Binge Eating Disorder (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04602936 | — | P4 | unknown | Solriamfetol in Binge Eating Disorder |
Excessive Daytime Sleepiness (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04789174 | SHARP | P4 | completed | Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study |
Chronic Fatigue Syndrome (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04622293 | — | P4 | completed | A Trial of Solriamfetol in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome |
Solriamfetol pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| SHARP | NCT04789174 | P4 | completed | Excessive Daytime Sleepiness | 59 | PMID 39528111 |
| CLARITY | NCT07484217 | P3 | recruiting | Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms | 508 | — |
| SUSTAIN | NCT06568367 | P3 | recruiting | Excessive Sleepiness | 520 | — |
| ENGAGE | NCT06413433 | P3 | recruiting | Binge-Eating Disorder | 450 | — |
| PARADIGM | NCT06360419 | P3 | completed | Major Depressive Disorder | 346 | — |
| FOCUS | NCT05972044 | P3 | completed | ADHD | 516 | — |
| EDS | NCT06103825 | P3 | completed | Sleep Apnea, Obstructive | 204 | PMID 41128833 |
| SOLR-IH | NCT06590662 | P2 | not yet recruiting | Idiopathic Hypersomnia | 60 | — |
| SOLARIMS | NCT06170970 | P2 | recruiting | Multiple Sclerosis | 46 | — |
| RECOVER-SLEEP | NCT06404099 | P2 | completed | Long COVID | 361 | — |
| RECOVER-SLEEP | NCT06404086 | P2 | completed | Long COVID | 830 | — |
Terminated and withdrawn Solriamfetol trials (1)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT04788953terminatedClinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder
All Solriamfetol trials (19)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT06413420 | SUNOSI® (Solriamfetol) Pregnancy Registry | — | recruiting | 1,731 | Axsome Therapeutics, Inc. | Jul 2019 | |
| NCT07484217 | CLARITY | Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol | P3 | recruiting | 508 | Axsome Therapeutics, Inc. | Feb 2026 |
| NCT06590662 | SOLR-IH | Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia. | P2 | not yet recruiting | 60 | University Hospital, Montpellier | Sep 2024 |
| NCT06170970 | SOLARIMS | Solriamfetol for the Treatment of Multiple Sclerosis Fatigue | P2 | recruiting | 46 | Johns Hopkins University | Jun 2024 |
| NCT06878976 | Open-Label Safety Study of Solriamfetol in Subjects With Binge Eating Disorder | P3 | enrolling by invitation | 300 | Axsome Therapeutics, Inc. | Feb 2025 | |
| NCT06568367 | SUSTAIN | Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN) | P3 | recruiting | 520 | Axsome Therapeutics, Inc. | Aug 2024 |
| NCT05838430 | Solriamfetol and CBT-I in Patients With Insomnia Disorder | P4 | completed | 115 | University of Pennsylvania | Jul 2023 | |
| NCT06404099 | RECOVER-SLEEP | RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia) | P2 | completed | 361 | Duke University | Aug 2024 |
| NCT06404086 | RECOVER-SLEEP | RECOVER-SLEEP: Platform Protocol | P2 | completed | 830 | Duke University | Jul 2024 |
| NCT06413433 | ENGAGE | Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol | P3 | recruiting | 450 | Axsome Therapeutics, Inc. | Apr 2024 |
| NCT06360419 | PARADIGM | Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol | P3 | completed | 346 | Axsome Therapeutics, Inc. | Mar 2024 |
| NCT05972044 | FOCUS | A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS) | P3 | completed | 516 | Axsome Therapeutics, Inc. | Jul 2023 |
| NCT04602936 | Solriamfetol in Binge Eating Disorder | P4 | unknown | 64 | Lindner Center of HOPE | Jun 2021 | |
| NCT04622293 | A Trial of Solriamfetol in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome | P4 | completed | 44 | Rochester Center for Behavioral Medicine | Apr 2021 | |
| NCT06103825 | EDS | A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Solriamfetol in the Treatment of Excessive Daytime Sleepiness (EDS) in Patients with Obstructive Sleep Apnea (OSA) | P3 | completed | 204 | Ignis Therapeutics (Suzhou) Limited | Aug 2023 |
| NCT04788953 | Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder | P4 | terminated | 84 | Charles A. Czeisler, PhD, MD | Jul 2021 | |
| NCT04839562 | ADHD | A Controlled Study of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD) in Adults | P2/P3 | completed | 66 | Massachusetts General Hospital | Aug 2021 |
| NCT04789174 | SHARP | Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study | P4 | completed | 59 | Axsome Therapeutics, Inc. | May 2021 |
| NCT05008341 | Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration | P1 | completed | 6 | Axsome Therapeutics, Inc. | Aug 2021 |
Solriamfetol clinical trials: frequently asked questions
- How many Solriamfetol clinical trials are there?
- 19 Solriamfetol clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 6 are actively recruiting participants. 10 are marked completed.
- Are Solriamfetol clinical trials recruiting in 2026?
- Yes — 6 Solriamfetol trials are actively recruiting in 2026, with 92 U.S. sites across 23 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is Solriamfetol being studied for?
- Solriamfetol is being studied for Obstructive Sleep Apnea, Excessive Sleepiness, Narcolepsy, Long COVID-19, Hypersomnia and 21 more. The trials are grouped by indication on this page.
- What phase is Solriamfetol in?
- Solriamfetol clinical trials span 5 Phase 4, 7 Phase 3, 4 Phase 2, 1 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Solriamfetol clinical trials?
- The lead sponsor across the most Solriamfetol trials is Axsome Therapeutics, Inc., with 9 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Solriamfetolas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
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