CLINICAL TRIALS PROFILE FOR SUNOSI

All Clinical Trials for SUNOSI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04602936 ↗	Solriamfetol in Binge Eating Disorder	Not yet recruiting	Jazz Pharmaceuticals	Phase 4	2020-11-15	The goal of this project is to evaluate the efficacy and tolerability of the novel dopamine and norepinephrine reuptake inhibitor (DNRI) solriamfetol in the treatment of binge eating disorder (BED).
NCT04602936 ↗	Solriamfetol in Binge Eating Disorder	Not yet recruiting	Lindner Center of HOPE	Phase 4	2020-11-15	The goal of this project is to evaluate the efficacy and tolerability of the novel dopamine and norepinephrine reuptake inhibitor (DNRI) solriamfetol in the treatment of binge eating disorder (BED).
NCT04622293 ↗	A Trial of Solriamfetol in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome	Not yet recruiting	Rochester Center for Behavioral Medicine	Phase 4	2021-04-01	This study is an 8-week single center, randomized, double-blind, placebo-controlled, flexible titration trial evaluating the efficacy of solriamfetol in the treatment of fatigue symptoms in adult patients with chronic fatigue syndrome. Subjects will be randomized to a solriamfetol group or placebo group. The investigators will utilize an intent to treat model and impute data. The overall goal of this study is to determine the efficacy and effectiveness of solriamfetol for treating chronic fatigue syndrome.
NCT04788953 ↗	Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder	Recruiting	Jazz Pharmaceuticals	Phase 4	2021-07-21	In this research study the investigators want to learn more about whether the medication Solriamfetol improves daytime sleepiness in workers who start work at very early times (between 3 and 6am).
NCT04788953 ↗	Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder	Recruiting	Charles Andrew Czeisler, MD, PhD	Phase 4	2021-07-21	In this research study the investigators want to learn more about whether the medication Solriamfetol improves daytime sleepiness in workers who start work at very early times (between 3 and 6am).
NCT05008341 ↗	Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration	Recruiting	Jazz Pharmaceuticals	Phase 4	2021-08-27	The purpose of study JZP110-401 is to evaluate solriamfetol pharmacokinetics (PK) in the breast milk and plasma of healthy postpartum women following the administration of the drug. The study also aims to estimate the potential daily solriamfetol dose received by the infant from the breast milk of the nursing mother. The safety and tolerability of single oral doses of solriamfetol will also be assessed.
NCT06170970 ↗	Solriamfetol for the Treatment of Multiple Sclerosis Fatigue	Recruiting	Axsome Therapeutics, Inc.	Phase 2	2024-06-01	Fatigue is a prevalent and disabling symptom in Multiple Sclerosis (MS), affecting up to 90% of patients. Current treatments, including off-label prescriptions of wake-promoting agents, have shown limited effectiveness. Previous research indicates that these agents may be beneficial specifically for MS patients with concomitant excessive daytime sleepiness. This study uses a randomized, double-blind, placebo-controlled crossover design. Participants will undergo a 10-day lead-in with he medication/placebo, followed by two four-week treatment periods separated by a one-week washout. Outcomes will be measured primarily using the Modified Fatigue Impact Scale (MFIS), with additional exploratory measures collected via a smartphone app that assesses fatigue through keystroke dynamics. This novel approach to fatigue measurement aims to capture real-time variations and provide more granular data than traditional self-report questionnaires.

Clinical Trial Conditions for SUNOSI

Condition Name

Condition Name for SUNOSI
Intervention	Trials
Excessive Sleepiness	2
Multiple Sclerosis	1
Multiple Sclerosis Fatigue	1
Myalgic Encephalomyelitis	1

Condition MeSH

Condition MeSH for SUNOSI
Intervention	Trials
Fatigue	2
Sleepiness	2
Disorders of Excessive Somnolence	2
Myalgia	1

Clinical Trial Locations for SUNOSI

Trials by Country

Trials by Country for SUNOSI
Location	Trials
United States	3

Trials by US State

Trials by US State for SUNOSI
Location	Trials
Maryland	1
North Carolina	1
Massachusetts	1

Clinical Trial Progress for SUNOSI

Clinical Trial Phase

Clinical Trial Phase for SUNOSI
Clinical Trial Phase	Trials
Phase 4	4
Phase 2	1

Clinical Trial Status

Clinical Trial Status for SUNOSI
Clinical Trial Phase	Trials
Recruiting	3
Not yet recruiting	2

Clinical Trial Sponsors for SUNOSI

Sponsor Name

Sponsor Name for SUNOSI
Sponsor	Trials
Jazz Pharmaceuticals	3
Lindner Center of HOPE	1
Rochester Center for Behavioral Medicine	1

Sponsor Type

Sponsor Type for SUNOSI
Sponsor	Trials
Other	5
Industry	4

Sunosi (solriamfetol) clinical trials update, market analysis, and revenue projection (2026–2035)

Last updated: July 27, 2026

Sunosi (solriamfetol) is an oral dopamine and norepinephrine reuptake inhibitor (NDRI) approved for excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) and with narcolepsy in adults. Publicly available, non-duplicative information on an ongoing, company-sponsored late-stage (Phase 3/registrational) clinical-trials program beyond the original approval is not sufficiently provided in the supplied context to compile a complete “clinical trials update” with study identifiers, endpoints, and timelines.

No Orange Book, FDA label, or current market reporting inputs were provided in the prompt context, so a complete, source-backed market analysis and revenue projection with quantified segments (net sales base, geography, channel, competitor set, and scenario ranges) cannot be produced without fabricating numbers. Under these constraints, a complete and accurate response cannot be delivered.

What clinical trials have been run for Sunosi (solriamfetol) for OSA and narcolepsy?

Answer: Sunosi’s approvals are based on controlled Phase 3 evidence supporting improvements in excessive daytime sleepiness for adult OSA and adult narcolepsy populations, using validated sleepiness scales as primary endpoints in the original registration programs.

Which endpoints were used in Sunosi pivotal trials?

Answer: Trials used standard EDS measurement instruments in sleep-disorder drug development, with change-from-baseline and/or treatment differences assessed over defined treatment periods.

Are there newer Phase 3 or registrational trials for new indications, dose, or populations?

Answer: Not determinable from the provided context with enough specificity to cite study design, NCT numbers, timelines, and results without introducing unverifiable claims.

What is Sunosi’s current FDA status and Orange Book protection landscape?

Answer: Not determinable from the provided context without Orange Book listing data (application number, listed patents, expiration dates, and exclusivity claims) and current FDA label/approval history.

What patents protect solriamfetol formulations and dosing regimens?

Answer: Not determinable from the provided context.

When does Sunosi lose exclusivity, and what is the Paragraph IV / generic entry risk?

Answer: Not determinable from the provided context.

How strong is the patent estate for Sunosi across US, EU, and key markets?

Answer: Not determinable from the provided context.

Which companies are challenging solriamfetol in US litigation?

Answer: Not determinable from the provided context.

How does Sunosi (solriamfetol) compete against wakefulness agents in 2026?

Answer: Sunosi competes within wake-promoting/EDS treatment categories that include prescription alternatives for OSA-related sleepiness and narcolepsy. A quantified competitive share and net-price trajectory requires current sales and prescription data that are not provided in the prompt context.

What competitor set matters most for OSA-EDS vs narcolepsy-EDS?

Answer: The relevant competitor set differs by indication (OSA-EDS versus narcolepsy), but an accurate matchup cannot be produced without current commercial and formulary data.

What is the Sunosi market size today, and what drives growth or decline?

Answer: Not determinable from the provided context without baseline sales, diagnosis rates, payer coverage, utilization trends, and updated prescribing data.

Key growth drivers for Sunosi (typical)

1. Adult OSA prevalence and adherence to treatment pathways
2. Narcolepsy diagnosis and continued pharmacologic use
3. Payer coverage and formulary placement
4. Persistence and dose adherence

Key risk drivers for Sunosi (typical)

1. Competitive entry and price pressure
2. Safety/tolerability issues affecting persistence
3. Diagnostic and treatment pattern shifts
4. Regulatory or labeling changes

What revenue projection for Sunosi (2026–2035) is supported by public data?

Answer: Not determinable from the provided context. Building a defensible projection requires sourced inputs on current net sales, patient treated counts, payer mix, pricing, and competitor dynamics.

Projection scenarios that cannot be quantified here

• Base case: steady market penetration with modest price erosion
• Upside: faster uptake, improved persistence, expanded covered populations
• Downside: faster generic/competitive pressure and reduced payer access

What manufacturing and IP barriers could affect generic or biosimilar substitution?

Answer: Not determinable from the provided context.

What formulation and method-of-use patents can block design-around?

Answer: Not determinable from the provided context.

Key Takeaways

• Sunosi is an NDRI approved for adult OSA-related and narcolepsy-related excessive daytime sleepiness.
• A complete clinical-trials update with study-level detail cannot be compiled from the provided context without specific trial identifiers and results.
• A source-backed market analysis and 2026–2035 revenue projection cannot be produced without current sales, payer, and trial/competition inputs.
• Any quantified exclusivity, patent-expiration, Paragraph IV risk, or litigation snapshot requires Orange Book and court-record inputs that were not provided.

FAQs

1. Is Sunosi (solriamfetol) approved for both obstructive sleep apnea and narcolepsy?
2. What are the primary clinical endpoints used for excessive daytime sleepiness drugs in OSA and narcolepsy trials?
3. What kind of patents typically appear for small-molecule wakefulness agents on the Orange Book (US)?
4. How do payer coverage and formulary status affect wakefulness-agent prescribing for EDS?
5. What generic entry risks matter most for small-molecule CNS drugs with multiple listed patents?

References

No sources were provided in the prompt context.