(Albany, US), November 9, 2026 – DelveInsight’s ‘Excessive Daytime Sleepiness Market Insights, Epidemiology and Market Forecast – 2036’ report delivers an in-depth understanding of Excessive Daytime Sleepiness, historical and forecasted epidemiology, as well as the excessive daytime sleepiness market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
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Key Takeaways from the Excessive Daytime Sleepiness Market Report
In February 2026, Harmony Biosciences announced that the US FDA had approved its supplemental New Drug Application (sNDA) for WAKIX tablets to treat cataplexy in pediatric patients aged 6 years and older with narcolepsy. With this approval, WAKIX became the first and only FDA-approved non-scheduled treatment option for both pediatric and adult patients with narcolepsy, regardless of cataplexy status.
According to DelveInsight’s analysis, the excessive daytime sleepiness market size was valued at approximately USD 7,500 million in the 7MM in 2025 and is projected to grow at a CAGR of 3% during 2026-2036.
The total number of diagnosed prevalent cases of Excessive Daytime Sleepiness in the 7MM was around 7,800,000 in 2025.
The United States accounted for the highest diagnosed prevalent population of Excessive Daytime Sleepiness, at around 4,200,000 cases in 2025.
In 2025, the highest revenue in the hypersomnia market was captured by XYWAV in narcolepsy, accounting for USD 1,130 million.
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.
Most existing treatments focus on symptomatic relief rather than addressing the underlying neurobiological mechanisms, resulting in persistent residual symptoms in many patients.
The leading Excessive Daytime Sleepiness companies include Bioprojet Pharma, Harmony Biosciences, Jazz Pharmaceuticals, Axsome Therapeutics, Suven Life Sciences, Theranexus, Takeda, and others.
Promising Excessive Daytime Sleepiness therapies include SUNOSI, WAKIX/OZAWADE, XYWAV, XYREM, AXS-12, SUVN-G3031, THN102, and others.
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Excessive Daytime Sleepiness Overview
Excessive Daytime Sleepiness 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 and shaping the excessive daytime sleepiness eds diagnosis market.
Excessive Daytime Sleepiness Epidemiology Segmentation in the 7MM
Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness
Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders
Total Treatable Cases of Excessive Daytime Sleepiness
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Excessive Daytime Sleepiness Epidemiology Key Findings
The United States encompasses the highest diagnosed prevalent population of Excessive Daytime Sleepiness, at around 4,200,000 cases in 2025.
Among EU4 and the UK, the UK accounts for the highest number of diagnosed prevalent cases of Excessive Daytime Sleepiness, whereas Spain accounts for the lowest number of prevalent cases.
As per the DelveInsight analysis, Japan accounted for approximately 16% of the diagnosed prevalent population of Excessive Daytime Sleepiness among the 7MM in 2025.
Approved Therapies for Excessive Daytime Sleepiness
Pitolisant (WAKIX/OZAWADE): Bioprojet Pharma/Harmony Biosciences
WAKIX is a selective histamine 3 (H₃) receptor antagonist/inverse agonist whose efficacy could be mediated through its activity at H₃ receptors, thereby increasing the synthesis and release of histamine, a wake-promoting neurotransmitter. Harmony has an exclusive license from Bioprojet to develop, manufacture, and commercialize WAKIX in the US. 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, making WAKIX 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 indicated to improve wakefulness in adults living with Excessive Daytime Sleepiness due to narcolepsy or OSA. Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to SUNOSI, excluding certain jurisdictions in Asia.
XYWAV and XYREM: Jazz Pharmaceuticals
Both are GABAB receptor agonists. XYWAV is approved for Excessive Daytime Sleepiness in narcolepsy and Idiopathic Hypersomnia, while XYREM is approved for narcolepsy.
Excessive Daytime Sleepiness Pipeline Analysis
AXS-12 (Reboxetine): Axsome Therapeutics
Reboxetine is a highly selective and potent norepinephrine reuptake inhibitor being developed for the treatment of narcolepsy, and it has been granted FDA ODD for this indication. The product is in Phase III of development. In December 2025, Axsome Therapeutics announced that it had received formal pre-NDA meeting minutes from the US FDA supporting an NDA submission for Reboxetine in narcolepsy.
Samelisant (SUVN-G3031): Suven Life Sciences
Samelisant is an oral, potent, selective histamine H3 receptor inverse agonist. The company recently announced Phase II proof-of-concept results in adult narcolepsy patients with and without cataplexy; the study met its primary endpoint, with a statistically significant and clinically meaningful reduction in Excessive Daytime Sleepiness on the Epworth Sleepiness Scale total score compared to placebo at Day 14.
THN102 (flecainide and modafinil): Theranexus
THN102 is in Phase II development for Parkinson’s Disease and Excessive Daytime Sleepiness.
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Excessive Daytime Sleepiness Market Outlook
The excessive daytime sleepiness market is expected to undergo a gradual transformation, with emerging therapies addressing key limitations of current options. The current market analysis shows a landscape anchored by wake-promoting agents and stimulants, along with management of underlying conditions such as CPAP therapy for sleep apnea. 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 also exploring next-generation therapies, combination approaches, and improved formulations to enhance efficacy, safety, and duration of action. In the hypersomnia treatment market, pipeline candidates such as XYWAV in Idiopathic Hypersomnia, and others, are expected to drive growth during the forecast period (2026–2036). In the us narcolepsy market, generics of PROVIGIL/MODIODAL (modafinil), NUVIGIL (armodafinil), and XYREM (sodium oxybate) are available, while Harmony Biosciences’ pediatric approval for WAKIX has expanded treatment options. However, challenges such as underdiagnosis, access to specialized care, and long-term safety considerations remain, shaping the future dynamics of the narcolepsy therapeutic market.
Excessive Daytime Sleepiness Market Drivers
Advancements in targeted and novel therapies: The development of wake-promoting agents and orexin receptor–targeted therapies is transforming the treatment landscape, 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 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 Market Barriers
Lack of disease-modifying therapies
Variable efficacy and tolerability of existing treatments, including risk of dependence with stimulants
Underdiagnosis and delayed identification of underlying causes
Residual symptoms despite treatment of primary disorders
Long-term use requirements and side effects such as cardiovascular risks, psychiatric symptoms, or sleep disturbances, which can limit adherence
Excessive Daytime Sleepiness Treatment Landscape
The treatment landscape for Excessive Daytime Sleepiness 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. Milder stimulants such as modafinil or armodafinil are usually tried first, followed by more effective amphetamine-like stimulants if needed. Sodium oxybate may be prescribed for narcolepsy with cataplexy, while antidepressants like SSRIs or SNRIs can address Excessive Daytime Sleepiness linked to mood disorders. Non-pharmacological approaches, including behavioral interventions, CBT-I, strategic napping, 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.
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Scope of the Excessive Daytime Sleepiness Market Report
Coverage: 7MM
Study Period: 2022-2036
Forecast Period: 2026-2036
Excessive Daytime Sleepiness Companies: Bioprojet Pharma, Harmony Biosciences, Jazz Pharmaceuticals, Axsome Therapeutics, Suven Life Sciences, Theranexus, Takeda, and others.
Excessive Daytime Sleepiness Therapies: SUNOSI, WAKIX/OZAWADE, XYWAV, XYREM, AXS-12, SUVN-G3031, THN102, and others.
Excessive Daytime Sleepiness Market Dynamics: Excessive Daytime Sleepiness market drivers and market barriers
Excessive Daytime Sleepiness Competitive Intelligence Analysis: SWOT Analysis, Conjoint Analysis
Excessive Daytime Sleepiness Unmet Needs, KOL Views, Reimbursement
Table of Contents
Key Insights
Report Introduction
Executive Summary
Key Events
Epidemiology and Market Forecast Methodology
Excessive Daytime Sleepiness (EDS) Market Overview at a Glance
Disease Background and Overview of Excessive Daytime Sleepiness (EDS)
Treatment and Management of Excessive Daytime Sleepiness (EDS)
Patient Journey of Excessive Daytime Sleepiness (EDS)
Epidemiology and Patient Population of Excessive Daytime Sleepiness (EDS)
Marketed Drugs
Emerging Drugs
Excessive Daytime Sleepiness (EDS): 7MM Market Analysis
Unmet Needs of Excessive Daytime Sleepiness (EDS)
SWOT Analysis of Excessive Daytime Sleepiness (EDS)
KOL Views of Excessive Daytime Sleepiness (EDS)
Market Access and Reimbursement of Excessive Daytime Sleepiness (EDS)
Appendix
DelveInsight Capabilities
Disclaimer
About DelveInsight
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