Restless Legs Syndrome Treatment Market Expected to reach USD 3.96 Billion by 2032

The restless legs syndrome treatment market, projected to be valued at USD 2.65 Billion in 2025, is anticipated to grow steadily, reaching USD 3.96 Billion by 2032 at a CAGR of 5.9% during the forecast period. This growth is fueled by the increasing global incidence of restless legs syndrome, particularly among the elderly, as well as a growing body of clinical research aimed at improving symptom management. Rising awareness of restless legs syndrome as a diagnosable neurological disorder, along with the development of improved dopamine agonists and non-dopaminergic therapies, is driving treatment uptake. Moreover, the expanding availability of prescription drugs and heightened focus on patient quality of life are further supporting the market expansion.

The full report is now available for purchase: https://www.coherentmi.com/industry-reports/restless-legs-syndrome-treatment-market

The restless legs syndrome treatment market is experiencing steady growth, propelled by increasing awareness and diagnosis rates, especially in aging populations and individuals with chronic conditions such as diabetes and kidney disease. The condition, characterized by uncomfortable sensations in the legs and an uncontrollable urge to move, is often underdiagnosed, but recent advancements in neurological diagnostics and sleep medicine are improving detection and patient outcomes. The demand for both dopaminergic and non-dopaminergic pharmacological therapies, including gabapentinoids and alpha-2-delta ligands, is growing due to their effectiveness in managing moderate to severe restless legs syndrome symptoms.

For instance, in April 2023, the U.S. FDA granted a De Novo request for Noctrix Health’s NTX100 TOMAC System, a device worn on the lower legs that provides electrical stimulation to the peroneal nerves. Clinical trials showed it was well‑tolerated and effectively suppressed moderate‑to‑severe restless legs syndrome symptoms, offering a novel alternative for patients who are refractory to medications.

Additionally, regulatory agencies such as the U.S. FDA and EMA are increasingly recognizing the burden of restless legs syndrome, providing expedited review pathways and orphan drug incentives for promising treatment candidates. This, combined with the rising focus on sleep health, advancements in personalized medicine, and increasing R&D investments, is expected to enhance therapeutic innovation and the market growth in the coming years.

There is a growing shift in the restless legs syndrome treatment landscape toward non-dopaminergic therapies, particularly due to concerns over long-term complications such as augmentation associated with dopamine agonists. Pharmaceutical companies are increasingly investing in alternative treatment modalities such as gabapentinoids, iron supplementation, and neuromodulation devices.

In September 2024, the American Academy of Sleep Medicine (AASM) updated its guidelines to strongly recommend alpha‑2‑delta ligands (gabapentin, gabapentin enacarbil, pregabalin) and iron supplementation, while conditionally recommending against the routine use of dopamine agonists like pramipexole, ropinirole, and rotigotine due to augmentation risks.

The emergence of wearable neuromodulation devices offers non-pharmacologic alternatives for restless legs syndrome patients seeking relief without drug-related side effects. These devices deliver targeted electrical stimulation to modulate peripheral nerve activity and improve symptoms.

In April 2023, the U.S. FDA approved Noctrix Health’s NTX100 TOMAC System, a wearable neuromodulation device that delivers high-frequency, low-level electrical stimulation to the peroneal nerves to alleviate moderate-to-severe restless legs syndrome in patients unresponsive to medication.

Restless legs syndrome remains significantly underdiagnosed and undertreated across many low- and middle-income countries, despite its rising prevalence among aging populations in regions such as Southeast Asia, Latin America, and Eastern Europe. These areas are experiencing rapid demographic shifts and increasing rates of comorbidities such as chronic kidney disease and diabetes, both established risk factors for restless legs syndrome.

According to the study “Prevalence and Clinical Correlates of Restless Legs Syndrome in Psychiatric Patients: A Cross-Sectional Study from North India,” published in January 2024 in the Indian Journal of Psychiatry and indexed by the U.S. National Library of Medicine, restless legs syndrome (RLS) prevalence was reported as 66.7% in patients with depression, 50% in those with anxiety, and 48% among individuals with somatoform disorders. Yet, awareness and diagnosis of RLS remained notably low.

However, limited access to specialists, low public awareness, and inadequate screening infrastructure continue to hinder treatment uptake in these regions. This presents a significant opportunity for pharmaceutical companies, medical device manufacturers, and digital health providers to expand their footprint through awareness campaigns, affordable therapeutic solutions, and mobile diagnostic programs. Strategic collaborations with regional neurology clinics, sleep centers, and public healthcare systems could help bridge these gaps and drive earlier diagnosis and intervention.

Given Restless legs syndrome’s chronic and often nocturnal nature, there is a growing opportunity to deploy digital health solutions—such as mobile apps, wearable devices, and tele-neurology platforms—to monitor symptoms, sleep patterns, and treatment adherence in real-time. These technologies can support personalized care delivery while reducing the burden of frequent clinic visits, especially for elderly or mobility-limited patients.

According to the study “Machine Learning-Based Prediction of Restless Legs Syndrome Using Digital Phenotypes from Wearables and Smartphone Data,” published in May 2025 and indexed by the U.S. National Library of Medicine, a South Korean clinical study demonstrated a predictive model for RLS using digital phenotyping. The model combined smartphone self-reported data with biometric signals from wearable devices, achieving an AUC of up to 0.86 for diagnosing moderate RLS—a promising advancement toward real-time, app-based symptom tracking and early detection.