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Albany, New York, October 13, 2026 — DelveInsight’s latest report, “Excessive Daytime Sleepiness – Market Insight, Epidemiology and Market Forecast – 2036,” provides a comprehensive analysis of the excessive daytime sleepiness (EDS) market, covering market size, disease epidemiology, current treatment practices, emerging therapies, competitive landscape, and future growth opportunities across the seven major markets (7MM): the United States, Germany, France, Italy, Spain, the United Kingdom, and Japan.

According to DelveInsight, the EDS market across the 7MM was valued at approximately USD 7,500 million in 2025 and is projected to grow at a CAGR of 3% from 2026 to 2036. The exact projected market value for 2036 is not publicly disclosed on the report page.

The market is supported by the continued use of wake-promoting agents and stimulants, growing recognition of sleep disorders, advances in sleep diagnostics, and the development of therapies designed to improve wakefulness and address limitations in existing treatment options.

Key Takeaways from the Excessive Daytime Sleepiness Market Report

• Market Size: The EDS market across the 7MM was valued at approximately USD 7,500 million in 2025.

• Market Growth: The market is projected to expand at a CAGR of 3% during 2026–2036.

• Epidemiology: Approximately 7.8 million diagnosed prevalent EDS cases were reported across the 7MM in 2025.

• Leading Country: The United States accounted for approximately 4.2 million diagnosed prevalent cases in 2025.

• European Epidemiology: Among the EU4 and the UK, the UK had the highest diagnosed prevalent population, while Spain had the lowest.

• Leading Marketed Therapies: SUNOSI (solriamfetol), WAKIX/OZAWADE (pitolisant), XYWAV, and XYREM are among the therapies covered in the report.

• Emerging Therapies: Pipeline candidates include AXS-12 (reboxetine), SUVN-G3031 (samelisant), and THN102.

• Key Companies: Bioprojet Pharma, Harmony Biosciences, Jazz Pharmaceuticals, Axsome Therapeutics, Suven Life Sciences, Theranexus, and Takeda are among the companies featured in the market analysis.

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Key Factors Driving the Excessive Daytime Sleepiness Market

1. Growing Recognition and Diagnosis of Sleep Disorders

Increasing awareness of sleep-related conditions and improvements in diagnostic approaches are supporting the identification of patients experiencing excessive daytime sleepiness. EDS is commonly associated with narcolepsy, obstructive sleep apnea (OSA), circadian rhythm disturbances, and other underlying medical conditions.

Diagnostic methods, including polysomnography and the multiple sleep latency test (MSLT), help clinicians assess sleep patterns and investigate the causes of persistent daytime drowsiness. Improved recognition of these conditions may expand the population eligible for appropriate treatment.

2. Continued Demand for Wake-Promoting Therapies

The current treatment landscape relies substantially on medications that improve wakefulness and alertness. Agents such as modafinil, armodafinil, and other stimulants are used in selected patient populations, while newer therapies provide additional options for specific underlying disorders.

Marketed treatments such as SUNOSI (solriamfetol) and WAKIX (pitolisant) contribute to the evolving therapeutic landscape. Their use depends on the underlying diagnosis, patient characteristics, treatment response, safety profile, and applicable prescribing guidance.

3. Advancements in Novel and Targeted Therapies

Research into the biological mechanisms governing the sleep–wake cycle is supporting the development of new therapeutic approaches. Emerging candidates are being investigated for conditions such as narcolepsy and other disorders associated with excessive daytime sleepiness.

AXS-12 (reboxetine), SUVN-G3031 (samelisant), and THN102 are among the pipeline candidates identified in DelveInsight’s report. Their future commercial impact will depend on clinical evidence, regulatory outcomes, safety, and their eventual place in treatment.

4. Persistent Unmet Medical Needs

Despite available treatment options, some patients continue to experience residual sleepiness, inconsistent treatment responses, or tolerability issues. Long-term medication use, adverse effects, and the need to manage underlying disorders can also complicate care.

These challenges create opportunities for therapies that offer sustained wakefulness, improved tolerability, and better daily functioning. Earlier diagnosis and more individualized treatment strategies may also improve patient outcomes.

Excessive Daytime Sleepiness Market Competitive Landscape

The EDS market includes established pharmaceutical companies with marketed therapies and developers advancing new treatment candidates.

Key companies covered in the report include:

• Bioprojet Pharma/Harmony Biosciences: Associated with pitolisant, marketed as WAKIX in the United States and under other regional brand names.

• Jazz Pharmaceuticals: Commercializes solriamfetol (SUNOSI) and oxybate-based therapies, including XYWAV and XYREM.

• Axsome Therapeutics: Developing AXS-12 (reboxetine) for narcolepsy.

• Suven Life Sciences: Associated with the development of SUVN-G3031 (samelisant).

• Theranexus: Associated with the THN102 development program.

• Takeda: Included among companies evaluated in the broader EDS market landscape.

Competition is shaped by treatment efficacy, safety and tolerability, product availability, regulatory approvals, pricing, reimbursement, and the ability of emerging therapies to address limitations of existing medications.

Recent Developments in the Excessive Daytime Sleepiness Treatment Landscape

• February 2026: Harmony Biosciences announced that the US Food and Drug Administration (FDA) had approved a supplemental new drug application for WAKIX tablets to treat cataplexy in pediatric patients aged six years and older with narcolepsy.

• December 2025: Axsome Therapeutics announced that it had received formal FDA pre-NDA meeting minutes supporting a new drug application submission for AXS-12 in narcolepsy.

These developments reflect continued clinical and regulatory activity in sleep medicine. The scope and commercial significance of each development depend on its specific indication and the applicable regulatory status.

What Is Excessive Daytime Sleepiness?

Excessive daytime sleepiness is a clinical condition characterized by difficulty maintaining wakefulness and alertness during waking hours. It may result in persistent drowsiness, unintended sleep episodes, reduced concentration, and impaired performance in daily activities.

EDS is not necessarily a standalone disease. It is frequently associated with underlying conditions such as narcolepsy, obstructive sleep apnea, circadian rhythm disturbances, and certain neurological or psychiatric disorders. Identifying the underlying cause is therefore an important component of clinical management.

Diagnosis typically involves a detailed medical and sleep history, clinical evaluation, and, when indicated, objective sleep testing. Polysomnography and the multiple sleep latency test may help clinicians investigate sleep disorders contributing to daytime sleepiness.

Current Treatment Landscape for Excessive Daytime Sleepiness

Treatment is guided by the underlying cause and the severity of symptoms. Management may involve pharmacological treatment, behavioral measures, and interventions directed at associated sleep disorders.

Common treatment approaches include:

• Wake-promoting agents: Modafinil and armodafinil are used in selected conditions to improve alertness.

• Solriamfetol (SUNOSI): Used to improve wakefulness in adults with EDS associated with narcolepsy or obstructive sleep apnea, according to its approved labeling.

• Pitolisant (WAKIX/OZAWADE): A histamine H3 receptor antagonist/inverse agonist used for specific indications related to narcolepsy and, in certain regions, OSA-associated EDS.

• Oxybate-based therapies: XYWAV and XYREM are used for specified sleep-disorder indications, including narcolepsy; XYWAV also has an indication for idiopathic hypersomnia in the United States.

• Treatment of underlying disorders: For patients with OSA, interventions such as continuous positive airway pressure (CPAP) may be an important part of management.

Treatment selection varies according to diagnosis, age, comorbidities, local approvals, contraindications, and individual response. Not every therapy is indicated for every cause of EDS.

Approved and Emerging Therapies in the Excessive Daytime Sleepiness MarketMarketed Therapies

SUNOSI (solriamfetol) — Jazz Pharmaceuticals

SUNOSI is a dopamine and norepinephrine reuptake inhibitor indicated to improve wakefulness in adults with EDS associated with narcolepsy or OSA. It is an established option in the treatment landscape for these conditions.

WAKIX (pitolisant) — Harmony Biosciences/Bioprojet Pharma

Pitolisant acts as a histamine H3 receptor antagonist/inverse agonist. It is used for specified narcolepsy-related indications, with approved uses varying by region. In February 2026, the US FDA approved an expanded pediatric indication for cataplexy in patients aged six years and older with narcolepsy.

XYWAV — Jazz Pharmaceuticals

XYWAV is an oxybate formulation used for specified indications that include cataplexy or EDS associated with narcolepsy and idiopathic hypersomnia in the United States. Its role in the market reflects the importance of treating the underlying sleep disorder rather than daytime symptoms alone.

XYREM — Jazz Pharmaceuticals/UCB Pharma Ltd

XYREM is a sodium oxybate therapy used for approved indications associated with narcolepsy. Its use is subject to prescribing requirements and safety considerations.

Emerging Therapies

AXS-12 (reboxetine) — Axsome Therapeutics

AXS-12 is being developed for narcolepsy. Reboxetine is a norepinephrine reuptake inhibitor, and the development program aims to address symptoms associated with narcolepsy, including excessive daytime sleepiness. The timing and outcome of regulatory review remain dependent on the development and submission process.

SUVN-G3031 (samelisant) — Suven Life Sciences

SUVN-G3031 is among the pipeline candidates covered in the report. Its potential market contribution will depend on further clinical evidence and development progress.

THN102 — Theranexus

THN102 is another investigational candidate included in the EDS pipeline landscape. Its future role will depend on clinical results, regulatory developments, and the needs of the patient population targeted.

Investigational candidates should not be considered approved treatment options unless and until the relevant regulator authorizes them for the intended indication.

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Excessive Daytime Sleepiness Epidemiology and Patient Population

DelveInsight estimates that approximately 7.8 million diagnosed prevalent EDS cases occurred across the 7MM in 2025.

Key epidemiological findings include:

• United States: Approximately 4.2 million diagnosed prevalent cases in 2025, representing the largest diagnosed population among the 7MM.

• Japan: Approximately 16% of the diagnosed prevalent EDS population across the 7MM in 2025.

• EU4 and the UK: The UK had the highest diagnosed prevalent population among these countries, while Spain had the lowest.

The report assesses diagnosed prevalent cases, cases associated with different underlying disorders, and the population considered treatable. These estimates provide context for assessing patient needs and the potential uptake of existing and emerging therapies.

Unmet Needs in the Excessive Daytime Sleepiness Market

Although several treatment options are available, important gaps remain:

• Residual symptoms: Some patients continue to experience daytime sleepiness despite treatment.

• Variable treatment response: Effectiveness and tolerability differ between patients and underlying conditions.

• Long-term safety and adherence: Adverse effects and the need for ongoing treatment may complicate management.

• Underdiagnosis: Delayed identification of EDS and its underlying cause can postpone appropriate care.

• Limited disease-modifying approaches: Many therapies primarily manage symptoms rather than correcting the underlying cause.

• Comorbidities and complex cases: Patients with multiple health conditions may require more individualized treatment strategies.

Addressing these unmet needs could support the development of more targeted therapies, improved diagnostic pathways, and better long-term patient outcomes.

Scope of the Excessive Daytime Sleepiness Market Report

DelveInsight’s Excessive Daytime Sleepiness – Market Insight, Epidemiology and Market Forecast – 2036 evaluates the disease and commercial landscape across the seven major markets.

Report details

• Study period: 2022–2036

• Historical period: 2022–2025

• Forecast period: 2026–2036

• Base year: 2026

• Geographies: United States, Germany, France, Italy, Spain, United Kingdom, and Japan

• Market forecast: Market size and growth trends by geography and therapy

• Epidemiology: Diagnosed prevalent cases, cases across different disorders, and treatable cases

• Treatment landscape: Current treatment practices, emerging therapies, and clinical development

• Competitive assessment: Company profiles, market share and therapy uptake, pricing, reimbursement, and unmet needs

• Strategic analysis: Market drivers and barriers, cost assumptions, key opinion leader perspectives, SWOT analysis, and conjoint analysis

Access the Full Excessive Daytime Sleepiness Market Report

For detailed insights into market trends, patient burden, marketed and emerging therapies, and forecast opportunities through 2036, visit: Excessive Daytime Sleepiness Market Insight, Epidemiology and Market Forecast – 2036

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary

4. Key Events

5. Epidemiology and Market Forecast Methodology

6. Excessive Daytime Sleepiness (EDS) Market Overview

7. Disease Background and Overview

8. Epidemiology and Forecast by Geography

9. Marketed Drugs and Emerging Pipeline Analysis

10. Competitive Landscape and Market Forecast

11. Unmet Needs and Future Market Opportunities

12. Appendix and Report Methodology

About DelveInsight

DelveInsight is a leading market research and consulting firm specializing in the life sciences and healthcare industries. Founded in 2014, the company provides comprehensive market intelligence, epidemiology, and insights across pharmaceuticals, biotechnology, medical devices, and emerging therapies. DelveInsight helps healthcare organizations make informed strategic decisions through data-driven research and industry expertise.

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