Excessive Daytime Sleepiness (EDS) - Market Insight, Epidemiology, and Market Forecast - 2036

Excessive Daytime Sleepiness (EDS) Insights and Trends

• According to DelveInsight's analysis, the Excessive Daytime Sleepiness (EDS) market size was found to be USD 7,500 million in the leading markets (the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan) in 2025.
• The current market is primarily anchored by wake-promoting agents and stimulants, including modafinil, armodafinil, and amphetamine-based therapies, which remain the standard of care for improving daytime alertness. Additionally, management of underlying conditions (e.g., CPAP therapy for sleep apnea) plays a critical role in comprehensive treatment.
• Despite the availability of multiple therapies, most treatments focus on symptomatic relief rather than addressing the underlying neurobiological mechanisms, resulting in persistent residual symptoms in many patients. While these agents improve wakefulness, they do not fully normalize sleep-wake regulation.
• Significant gaps remain due to variable patient response, tolerability issues, risk of dependence (in stimulants), and incomplete efficacy, particularly in patients with complex or comorbid conditions. This underscores a continued unmet need for more effective and targeted therapies.
• Existing treatments often require long-term or lifelong use, and some are associated with side effects such as cardiovascular risks, psychiatric symptoms, or sleep disturbances, which can limit adherence and overall effectiveness.
• The pipeline is evolving with a growing focus on novel mechanism-based therapies, including orexin receptor modulators and histamine pathway targeting agents, aimed at improving wakefulness through more physiological regulation of the sleep-wake cycle.
• Ongoing clinical research is exploring next-generation therapies, combination approaches, and improved formulations to enhance efficacy, safety, and duration of action. Increasing investment and advancements in sleep science are supporting this transition toward more targeted treatment strategies.
• The EDS market is expected to undergo a gradual transformation, with emerging therapies addressing key limitations of current options. However, challenges such as underdiagnosis, access to specialized care, and long-term safety considerations remain, shaping the future dynamics of the market.

DelveInsight's Excessive Daytime Sleepiness (EDS) - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the EDS, historical and forecasted epidemiology, as well as the EDS market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The EDS market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates EDS patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in EDS and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Key Factors Driving the Excessive Daytime Sleepiness (EDS) Market

Advancements in targeted and novel therapies: The development of wake-promoting agents and orexin receptor-targeted therapies is transforming the treatment landscape of EDS, offering improved efficacy and better management of underlying sleep-wake regulation mechanisms.

Increasing adoption of early and accurate diagnosis: Growing awareness of sleep disorders, along with advancements in diagnostic tools such as polysomnography and multiple sleep latency tests (MSLT), is enabling earlier identification of excessive daytime sleepiness, thereby expanding the treatable patient population.

Strong pipeline and supportive regulatory environment: A robust pipeline of novel therapeutics, coupled with regulatory incentives and increasing clinical research in sleep disorders, is accelerating innovation and contributing to market growth.

Excessive Daytime Sleepiness (EDS) Understanding and Treatment Algorithm

Excessive Daytime Sleepiness (EDS) Overview and Diagnosis

EDS is a clinical condition characterized by an inability to maintain wakefulness and alertness during the day, often resulting in unintended lapses into sleep. It is commonly associated with underlying sleep disorders such as narcolepsy, obstructive sleep apnea, and circadian rhythm disturbances, as well as neurological or psychiatric conditions. Patients typically present with persistent drowsiness, reduced concentration, and impaired daily functioning. Diagnosis involves a comprehensive clinical evaluation, sleep history assessment, and objective testing such as polysomnography and the multiple sleep latency test (MSLT). Advances in sleep diagnostics are enabling more accurate identification of underlying causes, supporting targeted management strategies.

Current Excessive Daytime Sleepiness (EDS) Treatment Landscape

The treatment landscape for EDS focuses on improving wakefulness and addressing the underlying cause. Pharmacological management includes wake-promoting agents and stimulants, such as modafinil and amphetamine-based therapies, along with newer agents targeting sleep-wake pathways. Non-pharmacological approaches, including behavioral interventions and management of primary sleep disorders (e.g., CPAP therapy for sleep apnea), are also critical components of care. While these therapies provide symptomatic relief, variability in patient response and tolerability issues persist, highlighting the need for more effective and targeted options.

Excessive Daytime Sleepiness (EDS) Unmet Needs

The section "unmet needs of Excessive Daytime Sleepiness (EDS)" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

1. Lack of disease-modifying therapies

2. Variable efficacy and tolerability of existing treatments

3. Underdiagnosis and delayed identification of underlying causes

4. Residual symptoms despite treatment of primary disorders

5. Impact on quality of life and daily functioning, and others.....

Excessive Daytime Sleepiness (EDS) Epidemiology

Key Findings from Excessive Daytime Sleepiness (EDS) Epidemiological Analysis and Forecast

• The total number of diagnosed prevalent cases of Excessive Daytime Sleepiness (EDS) in the 7MM was around 7,800,000 in 2025.
• The United States encompasses the highest diagnosed prevalent population of EDS, around 4,200,000 in 2025.
• Among EU4 and the UK, the UK accounts for the highest number of diagnosed prevalent cases of EDS, whereas Spain accounts for the least number of prevalent cases.
• As per the DelveInsight analysis, it was observed that Japan accounted for approximately 16% diagnosed prevalent population of EDS among 7MM, in the year 2025.

Excessive Daytime Sleepiness (EDS) Drug Chapters & Competitive Analysis

The EDS drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I-III clinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the EDS treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the EDS market.

Approved Therapies for Excessive Daytime Sleepiness (EDS)

Pitolisant (WAKIX/OZAWADE): Bioprojet Pharma/Harmony Biosciences

WAKIX is a selective histamine 3 (H3) receptor antagonist/inverse agonist. The mechanism of action of WAKIX is unclear; however, its efficacy could be mediated through its activity at H3 receptors, thereby increasing the synthesis and release of histamine, a wake-promoting neurotransmitter. WAKIX was designed and developed by Bioprojet (France). Harmony has an exclusive license from Bioprojet to develop, manufacture, and commercialize WAKIX in the US. It was granted orphan drug designation (ODD) for the treatment of narcolepsy in 2010 and breakthrough therapy designation for the treatment of cataplexy in 2018.

In February 2026, Harmony Biosciences announced that the US Food and Drug Administration (FDA) had approved its supplemental new drug application (sNDA) for WAKIX tablets for the treatment of cataplexy in pediatric patients 6 years of age and older with narcolepsy. WAKIX is now the first and only FDA-approved non-scheduled treatment for pediatric and adult narcolepsy patients with or without cataplexy.

Solriamfetol (SUNOSI): Jazz Pharmaceuticals

SUNOSI is a dual-acting dopamine and norepinephrine reuptake inhibitor that is indicated to improve wakefulness in adults living with EDS due to narcolepsy or OSA. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize SUNOSI from Aerial Biopharma. Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to SUNOSI, excluding certain jurisdictions in Asia. SK Biopharmaceuticals, the discoverer of the compound, maintains rights in 12 Asian markets, including Korea, China, and Japan. SUNOSI has received ODD for narcolepsy in the US.

Excessive Daytime Sleepiness (EDS) Pipeline Analysis

AXS-12 (Reboxetine): Axsome Therapeutics

Reboxetine is a highly selective and potent norepinephrine reuptake inhibitor being developed for the treatment of narcolepsy. It is thought to modulate noradrenergic activity to promote wakefulness, maintain muscle tone, and enhance cognition. Reboxetine has an extensive safety record in Europe and in over 40 countries where it's approved for the treatment of depression. In narcolepsy, Reboxetine is supported by positive pre-clinical and Phase II clinical results. Reboxetine has been granted FDA ODD for the treatment of narcolepsy. The product is in Phase III of development.

In December 2025, Axsome Therapeutics announced that it had received formal pre-New Drug Application (NDA) meeting minutes from the US FDA supporting an NDA submission for Reboxetine in narcolepsy. Reboxetine is a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator. The purpose of the meeting was to reach an agreement with the FDA on the proposed content and format of the Company's planned NDA submission, including the clinical and nonclinical requirements.

Samelisant (SUVN-G3031): Suven Life Sciences

Samelisant is an oral, potent, selective, and well-differentiated histamine H3 receptor inverse agonist. Its efficacy has been established in nonclinical sleep models. The drug has shown excellent ADME properties with no drug-drug interaction liability. It enhanced the in vivo release of several neurotransmitters in the cortex and showed robust wake-promoting effects in various animal models. Samelisant has an excellent safety profile in preclinical models with no propensity to induce abuse liability. The drug candidate was evaluated in two Phase I studies in the US in 72 healthy adult and elderly male/female populations with no serious adverse events.

The company recently announced the results of a Phase II proof-of-concept study, assessing the safety and efficacy of Samelisant for the treatment of excessive daytime sleepiness in adult narcolepsy patients with and without cataplexy. The study met the primary endpoint, with Samelisant demonstrating a statistically significant and clinically meaningful reduction in Excessive Daytime Sleepiness measured by the Epworth Sleepiness Scale total score compared to the placebo at Day 14.

Excessive Daytime Sleepiness (EDS) Key Players, Market Leaders, and Emerging Companies

• Bioprojet Pharma/Harmony Biosciences
• Jazz Pharmaceuticals
• Axsome Therapeutics
• Suven Life Sciences
• Theranexus
• Takeda, and others.

Excessive Daytime Sleepiness (EDS) Drug Updates

• In February 2026, Harmony Biosciences announced that the US FDA had approved its sNDA for WAKIX tablets for the treatment of cataplexy in pediatric patients 6 years of age and older with narcolepsy. WAKIX is now the first and only FDA-approved non-scheduled treatment for pediatric and adult narcolepsy patients with or without cataplexy.
• In December 2025, Axsome Therapeutics announced that it had received formal pre-NDA meeting minutes from the US FDA supporting an NDA submission for AXS-12 in narcolepsy.

Excessive Daytime Sleepiness (EDS) Market Outlook

The current treatment landscape for EDS encompasses a range of approaches tailored to individual needs. This includes prescription medications like modafinil and armodafinil, which promote wakefulness, along with stimulants such as amphetamines. Sodium oxybate may be prescribed for narcolepsy with cataplexy, while antidepressants like SSRIs or SNRIs can address EDS linked to mood disorders. Lifestyle modifications, behavioral therapies like CBT-I, and strategic napping strategies also play significant roles. For those with sleep apnea, CPAP therapy is effective, while weight management can be beneficial for overweight individuals. Consulting a healthcare professional is essential to determine the best course of action.

Typically, a patient is started on a low dose, which is then increased progressively to obtain satisfactory results. Milder stimulants with low efficacy and potency, such as modafinil or armodafinil, are usually tried first. More effective amphetamine-like stimulants (methylphenidate, D-amphetamine, and methamphetamine) are then used if needed. Stimulant compounds are generally well tolerated in patients with narcolepsy.

There are a few drugs approved in the 7MM for the treatment of EDS, such as PROVIGIL/MODIODAL (modafinil), NUVIGIL (armodafinil), SUNOSI (solriamfetol), WAKIX (Pitolisant), XYWAV (calcium, magnesium, potassium, and sodium oxybates), and XYREM (sodium oxybate). The generics of PROVIGIL/MODIODAL (modafinil) and NUVIGIL (armodafinil), and XYREM (sodium oxybate) are available in the US market.

In recent years, there has been growing interest in novel treatment approaches for EDS, including orexin receptor antagonists, which target the dysregulation of orexin signaling implicated in narcolepsy.

• In 2025, the total market size of EDS by therapies was USD 7,500 million in the 7MM. The highest revenue was captured by XYWAV in narcolepsy, accounting for USD 1,130 million in 2025.
• During the forecast period (2026-2036), pipeline candidates such as XYWAV in Idiopathic Hypersomnia, and others are expected to drive the growth of the EDS market size.

Drug Class/Insights into Leading Emerging and Marketed Therapies in Excessive Daytime Sleepiness (EDS) (2022-2036 Forecast)

The treatment landscape of EDS remains largely focused on symptomatic management and improving daytime alertness; however, emerging therapies are increasingly targeting the underlying neurobiological mechanisms of sleep-wake regulation.

Wake-promoting and stimulant therapies: Current pharmacological options primarily aim to enhance wakefulness and reduce daytime sleep episodes. Agents such as modafinil, armodafinil, and amphetamine-based stimulants are widely used as first-line treatments, acting on central nervous system pathways to improve alertness and cognitive function. While effective, these therapies are associated with variability in response and potential side effects, necessitating individualized treatment approaches.

Targeted and novel therapies: Recent advancements include therapies targeting specific pathways involved in sleep regulation, such as orexin receptor modulators and histamine-based agents. These approaches aim to address the underlying pathophysiology of EDS, particularly in conditions like narcolepsy, and offer the potential for improved efficacy and sustained wakefulness. Ongoing research is focused on developing next-generation agents that provide better safety, tolerability, and long-term outcomes.

Excessive Daytime Sleepiness (EDS) Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the EDS market's uptake by drugs, patient uptake by therapy, and sales of each drug.

Among the therapies, XYWAV is expected to capture the largest market share. XYWAV is expected to witness strong uptake in the Excessive Daytime Sleepiness (EDS) market, primarily driven by its differentiated clinical and safety profile. One of the key advantages of XYWAV over XYREM is its significantly lower sodium content, which reduces long-term cardiovascular risk-an important consideration for patients requiring chronic therapy. This improved safety profile is likely to encourage both physicians and patients to prefer XYWAV, particularly in populations with comorbid cardiovascular concerns.

Detailed insights into emerging therapies' drug uptake are included in the report...

Market Access and Reimbursement of Approved Therapies in Excessive Daytime Sleepiness (EDS)

Reimbursement is a crucial factor that affects the drug's access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.

HealthPartners' Medicaid List of Covered Drugs includes SUNOSI within a quantity limit of one tablet a day. To avail of the reimbursement, the patient must get prior authorization before filling a prescription for this drug. HealthPartners is an integrated, nonprofit health care provider and health insurance company located in Bloomington, Minnesota, offering care, coverage, research, and education to its members, patients, and the community.

In July 2020, Haute Autorite de Sante (HAS) posted a favorable opinion for reimbursement of Sunosi to improve wakefulness and reduce EDS:

• In adult patients with narcolepsy (with or without cataplexy), use only in the event of non-response, intolerance, or contraindication to the therapeutic alternatives currently available.
• In adult patients with obstructive sleep apnea (OSA), only in treatment-compliant patients whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).

NOTE: Further Details are provided in the final report....

Excessive Daytime Sleepiness (EDS) Therapies Price Scenario & Trends

Pricing and analogue assessment of EDS therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, the closest and most appropriate analogue selection for emerging therapies, and the understanding of how pricing influences market access, adherence, and long-term uptake.

• Pricing of EDS-Approved Drugs

XYWAV is approved for managing cataplexy or EDS in narcolepsy patients aged 7 years and older. The initial recommended oral dose is 4.5 g nightly, split into two 2.25 g doses: one at bedtime and the second 2.5-4 hours later. Its annual cost is approximately USD 165,000.

Industry Experts and Physician Views for Excessive Daytime Sleepiness (EDS)

To keep up with EDS market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the EDS emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in EDS, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 10+ KOLs to gather insights at the country level. Centers such as the EDS Research Foundation (MMRF), University of Texas MD Anderson Cancer Center, and Iwate Medical University, etc. were contacted. Their opinion helps understand and validate current and emerging EDS therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in EDS.

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of EDS, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are mainly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Scope of the Report:

• The report covers a segment of key events, an executive summary, a descriptive overview of EDS, explaining its causes, signs and symptoms, pathogenesis, and currently available treatments.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the EDS market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM EDS market.

Report Insights

• Excessive Daytime Sleepiness (EDS) Patient Population Forecast
• Excessive Daytime Sleepiness (EDS) Market Opportunity (Current and Forecasted)
• Excessive Daytime Sleepiness (EDS) Pipeline Analysis
• Excessive Daytime Sleepiness (EDS) Market Size and Trends
• Excessive Daytime Sleepiness (EDS) Market Opportunity (Current and Forecasted)

Report Key Strengths

• Epidemiology-based (Epi-based) bottom-up Forecasting
• Artificial Intelligence (AI)-enabled Market Research Report
• 11-year Forecast
• Excessive Daytime Sleepiness (EDS) Market Outlook (North America, Europe, Asia-Pacific)
• Patient Burden Trends (by geography)
• Excessive Daytime Sleepiness (EDS) Treatment Addressable Market (TAM)
• Excessive Daytime Sleepiness (EDS) Competitive Landscape
• Excessive Daytime Sleepiness (EDS) Major Companies Insights
• Excessive Daytime Sleepiness (EDS) Price Trends and Analogue Assessment
• Excessive Daytime Sleepiness (EDS) Therapies and Drug Adoption/Uptake
• Excessive Daytime Sleepiness (EDS) Therapies Peak Patient Share Analysis

Report Assessment

• Excessive Daytime Sleepiness (EDS) Current Treatment Practices
• Excessive Daytime Sleepiness (EDS) Unmet Needs
• Excessive Daytime Sleepiness (EDS) Clinical Development Analysis
• Excessive Daytime Sleepiness (EDS) Emerging Drugs Product Profiles
• Excessive Daytime Sleepiness (EDS) Market Attractiveness
• Excessive Daytime Sleepiness (EDS) Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

Market Insights

• What was the EDS market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
• What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
• What can be the future treatment paradigm of EDS?
• What are the disease risks, burdens, and unmet needs of EDS? What will be the growth opportunities across the 7MM concerning the patient population with EDS?
• Who is the major future competitor in the market, and how will the competitors affect their market share?
• What are the current options for the treatment of EDS? What are the current guidelines for treating EDS in the US, Europe, and Japan?

Reasons to Buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the EDS market.
• Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• To understand KOLs' perspectives on the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights into the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
• This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets within the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.