Idiopathic Hypersomnia (IH) Treatment Market

The global Idiopathic Hypersomnia (IH) Treatment Market is valued at USD 340.4 Million in 2024 and is projected to reach a value of USD 835.2 Million by 2035 at a CAGR (Compound Annual Growth Rate) of 8.5% between 2025 and 2035.

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Idiopathic hypersomnia (IH) is a rare neurological sleep disorder characterized by excessive daytime sleepiness (EDS) despite prolonged nighttime sleep. Individuals with IH often sleep normal or extended hours at night yet continue to experience overwhelming drowsiness during the day. Symptoms may include unrefreshing naps, difficulty waking up (often referred to as sleep drunkenness), and persistent fatigue. The exact cause of idiopathic hypersomnia is unknown, and no treatments have been specifically approved by the U.S. FDA for this condition. However, medications like dextroamphetamine, which are approved for narcolepsy a related type of hypersomnia—are sometimes used off-label to manage IH symptoms.

The Idiopathic Hypersomnia (IH) Treatment Market is being driven by several key factors, starting with the increasing awareness of sleep disorders and the growing recognition of idiopathic hypersomnia as a significant health issue. As awareness rises, more individuals are seeking diagnosis and treatment for excessive daytime sleepiness (EDS) and other related symptoms. This heightened awareness has led to greater emphasis on research and development in the field of sleep medicine, with a focus on improving diagnostic techniques and treatment options. Furthermore, lifestyle-related factors such as stress, anxiety, and irregular sleep patterns, which are linked to an increase in sleep disorders, are contributing to the growing demand for IH treatments. The shift towards healthier living and better sleep hygiene practices also encourages individuals to seek treatment for sleep-related disorders, driving Idiopathic Hypersomnia (IH) Treatment market growth.

Key Highlights

• In 2024, based on the Drug Class, the Stimulant Medications category accounted for significant market share of 53.5% in Idiopathic Hypersomnia (IH) Treatment market
• North America dominated the Idiopathic Hypersomnia (IH) Treatment market with 50.5% market share in 2024
• Asia Pacific region is anticipated to grow at the highest CAGR during the forecast period

Drug Class Overview

​The Drug Class segment is divided into Stimulant Medications, Non-stimulant wake-promoting Medications, Sodium Oxybate. The Stimulant Medications segment held the largest share of 53.5% in the Idiopathic Hypersomnia (IH) Treatment market.

Stimulant Medications includes drugs like dextroamphetamine and modafinil, are commonly used to manage excessive daytime sleepiness (EDS) associated with IH. They work by stimulating the central nervous system to enhance alertness and reduce fatigue. Due to their proven efficacy in treating hypersomnia symptoms and their ability to provide relief to patients who experience debilitating daytime sleepiness, stimulant medications are the preferred treatment option in many cases. This segments dominance is expected to continue as ongoing research and development efforts lead to improved formulations and alternatives within the stimulant class.

Stimulants are the most commonly prescribed medications for hypersomnia, aimed at enhancing wakefulness and addressing symptoms related to disturbed nocturnal sleep and sleep paralysis. Modafinil, a widely used stimulant for narcolepsy, is a non-amphetamine central nervous system (CNS) stimulant known for its wakefulness-promoting properties. According to an article, solriamfetol is the primary therapy for excessive sleepiness associated with obstructive sleep apnea or narcolepsy, whether as initial, replacement, or adjunctive treatment.

Distribution Channel Overview

​The Distribution Channel segment is divided into Hospital Pharmacies, Retail Pharmacies, Online Pharmacies.

Hospital pharmacies plays a vital role in distributing medications and medical devices used in the management of hypersomnia and related conditions within hospital settings. These pharmacies ensure that patients admitted to healthcare facilities have timely access to necessary treatments.

Retail pharmacies also form an important segment, providing hypersomnia treatment products, including prescription refills, over-the-counter medications, and medical devices, to patients in community settings for home use.

Online pharmacies are an increasingly popular segment, offering patients the convenience of accessing treatments through digital platforms, allowing them to order medications and supplies for home delivery.

Regional Overview

In 2024, the North America captured 50.5% of the revenue share

North America Idiopathic Hypersomnia (IH) Treatment market is driven by increased awareness and robust investment in research and development. The growing prevalence of lifestyle-related conditions in the United States is a key factor fueling demand for hypersomnia treatments. According to the National Sleep Foundations Sleep in America poll, the Sleep Health Index consistently scored 77 out of 100 in 2021, reflecting persistent issues with sleep quality due to factors like light exposure, screen use, meal timing, physical activity, health, and stress. Additionally, data from the National Institute of Neurological Disorders and Stroke (NINDS) estimated that 135,000 to 200,000 people in the U.S. have narcolepsy, though the true numbers could be higher due to underdiagnosis. Efforts by organizations like the NINDS and the National Center on Sleep Disorders Research (NCSDR) have advanced understanding of sleep disorders, focusing on genetics, biochemistry, and sleep biology. The National Institute of Health Sleep Research Plan outlines strategic goals and priorities to expand sleep and circadian research, offering new opportunities for treatment development. Rising awareness of sleep disorders has also spurred the approval and launch of innovative drugs for hypersomnia treatment. Combined with increasing investments in healthcare, these developments are expected to drive Idiopathic Hypersomnia (IH) Treatment market growth in the region.

Asia Pacific Idiopathic Hypersomnia (IH) Treatment Market

The Asia Pacific Idiopathic Hypersomnia (IH) Treatment market is set for significant growth, driven by increasing healthcare awareness, rising rates of sleep disorders, and improving access to medical care. As countries in the region, particularly Japan, China, and India, continue to focus on enhancing healthcare infrastructure and expanding research on sleep-related disorders, the demand for effective IH treatments is expected to rise. Additionally, the growing prevalence of lifestyle-related conditions, such as stress, anxiety, and depression, which are linked to sleep disturbances, is further fueling market expansion. With increasing healthcare investments, collaborations between local and global pharmaceutical companies, and the ongoing development of innovative treatment options, the market is poised for substantial growth in the coming years.

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COVID-19 Impact

The COVID-19 outbreak spread to over 100 countries and was declared a public health emergency by the World Health Organization (WHO). As of October 2020, WHO reported over 45 million confirmed cases of COVID-19 globally. The pandemic has significantly impacted the global economy, including the idiopathic hypersomnia treatment market. In response to the growing prevalence of COVID-19, key market players have intensified their research and development efforts to create innovative products aimed at addressing pandemic-related challenges. However, widespread quarantines, travel restrictions, and social distancing measures have led to reduced business activity and consumer spending, particularly through the third quarter of 2020.

Key Trends

• Focus on Innovative Therapies: Development of advanced formulations such as extended-release sodium oxybate (e.g., LUMRYZ) and novel agents like Mazindol ER to enhance treatment efficacy and patient convenience
• Increased Awareness and Diagnosis: Growing efforts to educate healthcare providers and patients are leading to higher diagnosis rates and an expanding treatment-eligible population
• Regulatory Pathways: Initiatives like Named Patient Programs are enabling pre-approval access to investigational treatments, especially in regions with unmet therapeutic needs
• R&D Investments: Significant funding in research and development is driving a robust pipeline of novel IH treatments
• Strategic Collaborations: Partnerships between pharmaceutical companies and service providers are accelerating drug development and market entry
• Patient-Centric Solutions: Emphasis on addressing unmet needs through therapies that offer improved safety, convenience, and quality of life for IH patients

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Market Dynamics

Rising Prevalence of Lifestyle-Related Disorders

The increasing incidence of lifestyle-related conditions, such as anxiety and depression, which disrupt sleep cycles, is driving the demand for idiopathic hypersomnia treatments. These diseases, which result in excessive daytime drowsiness and hypersomnia, are influenced by behavioral changes and social activities. For example, 40 million persons in the United States suffer from anxiety disorders each year, according to the Anxiety and Depression Association of America, which generates a sizable patient base for associated therapies.

Advancements in Diagnostic Tools

Technological advancements in diagnostic methods, such as the multiple sleep latency test (MSLT), are improving the identification and diagnosis of idiopathic hypersomnia. Offered by AASM-accredited sleep centers in the U.S., these tools enable earlier and more accurate diagnosis, supporting Idiopathic Hypersomnia (IH) Treatment market growth.

Side Effects of Off-Label Treatments

Current off-label treatments for idiopathic hypersomnia, such as dextroamphetamine, often cause adverse effects, including aggressive behavior and dependency. These limitations, coupled with the lack of FDA-approved medications, hinder Idiopathic Hypersomnia (IH) Treatment market growth.

Challenges in Clinical Trials

A declining patient pool for clinical trials poses a significant barrier to research and development efforts. This setback delays the approval of new therapies, further slowing the growth of the Idiopathic Hypersomnia (IH) Treatment market.

Competitive Landscape

The Idiopathic Hypersomnia (IH) Treatment market is evolving, driven by the introduction of innovative therapies and strategic collaborations. Key players such as Avadel Pharmaceuticals and NLS Pharmaceutics are advancing treatments like LUMRYZ, an extended-release sodium oxybate formulation, and Mazindol ER, a novel therapy available through Named Patient Programs in Europe. These developments highlight the growing focus on addressing unmet needs in IH management. Companies are leveraging regulatory pathways, pre-approval access initiatives, and advanced drug formulations to enhance market positioning, while the entry of new players and the diversification of treatment options are intensifying competition in Idiopathic Hypersomnia (IH) Treatment market.

The key players in the global Idiopathic Hypersomnia (IH) Treatment market include - Merck & Co. Inc. among others.

Recent Market Developments

Avadel Pharmaceuticals Launches LUMRYZ for Cataplexy and Idiopathic Hypersomnia Treatment

• August 2024: Avadel Pharmaceuticals plc, a biopharmaceutical company dedicated to improving lives through innovative medicines, announced the commercial availability of LUMRYZ. This extended-release sodium oxybate formulation is designed for once-nightly dosing to treat cataplexy, excessive daytime sleepiness (EDS), and idiopathic hypersomnia (IH) in adults

NLS Pharmaceutics Partners with CCPS to Provide Pre-Approval Access to Mazindol ER in Europe

• 2022: NLS Pharmaceutics Ltd. disclosed an agreement with Caligor Coghlan Pharma Services (CCPS) to launch a Named Patient Program. This initiative allows European patients with idiopathic hypersomnia (IH) to access the company’s experimental Mazindol ER treatment prior to regulatory approval. Through the program, CCPS facilitates Mazindol ER distribution, enabling physicians to prescribe it to patients unresponsive to existing IH treatments

NLS Pharma Receives Positive Opinion for Orphan Drug Designation of Mazindol ER (Quilience) for Idiopathic Hypersomnia Treatment

• In July 2022, NLS Pharma Ltd. announced that the Committee for Orphan Medical Products (COMP) of the European Medicines Agency (EMA) had provided a positive opinion to grant Orphan Drug Designation (ODD) for Mazindol ER (Quilience) in the treatment of idiopathic hypersomnia (IH)

Harmony Biosciences Initiates Phase 3 Trial to Evaluate Pitolisant for Idiopathic Hypersomnia in Adults

• In April 2022, Harmony Biosciences Holdings, Inc. launched a Phase 3 clinical trial, known as the INTUNE study, to assess the efficacy and safety of pitolisant in adult patients with idiopathic hypersomnia (IH)

The global Idiopathic Hypersomnia (IH) Treatment market can be categorized as Drug Class, Distribution Channel and Region.