Modern Approaches to The Treatment of Restless Legs Syndrome: The Role of Dopaminergic Drugs

Authors

DOI:

https://doi.org/10.61788/njn.v2i28.06

Keywords:

restless legs syndrome, pramipexole, pilot study

Abstract

Objective. To evaluate the efficacy and tolerability of pramipexole in patients with idiopathic restless legs syndrome (RLS). Material and methods. A prospective open-label pilot study included 11 patients with idiopathic RLS (aged 49–65 years) treated at the National Medical Center of the Republic of Tajikistan “Shifobakhsh”. Pramipexole was administered with dose titration up to 1.0 mg (n=6); the control group (n=5) received placebo. Treatment duration was 4 weeks. Clinical outcomes were assessed using the (International Restless Legs Syndrome Rating Scale) (IRLS), RLS Ordinal Scale, Clinical Global Impression – Improvement (CGI-I) and Patient Global Impression of Change (PGIC). Results. After 4 weeks, the pramipexole group showed a significant reduction in IRLS scores (28.3±4.2 to 9.5±3.1; >65% improvement) and significant improvement on the RLS Ordinal Scale (p<0.05). CGI-I and PGIC indicated marked clinical and subjective improvement in the pramipexole group, while no significant changes were observed in the control group. No serious adverse events or augmentation were detected. Conclusions. Pramipexole was effective and well tolerated in idiopathic RLS over a 4-week treatment period, supporting the role of dopaminergic dysfunction in disease pathogenesis.

References

Allen RP, Picchietti DL, Garcia-Borreguero D, et al. Restless legs syndrome/Willis–Ekbom disease diagnostic criteria: updated International Restless Legs Syndrome Study Group (IRLSSG) consensus criteria // Sleep Med. 2014;15(8):860–873. doi: 10.1016/j.sleep.2014.03.025

Garcia-Borreguero D, Silber MH, Winkelman JW, Högl B, et al. Guidelines for the first-line treatment of restless legs syndrome/Willis-Ekbom disease, prevention and treatment of dopaminergic augmentation: a combined task force of the IRLSSG, EURLSSG, and the RLS-foundation // Sleep Med. 2016 May;21:1-11. doi: 10.1016/j.sleep.2016.01.017

Trenkwalder C, Allen R, Högl B, Paulus W, et al. Treatment of restless legs syndrome: an evidence-based review and implications for clinical practice. Mov Disord. 2018;33(7):1077–1091. doi: 10.1002/mds.27302

Winkelman JW, Armstrong MJ, Allen RP, Chaudhuri KR, et al. Practice guideline summary: Treatment of restless legs syndrome in adults: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2016 Dec 13;87(24):2585-2593. doi: 10.1212/WNL.0000000000003388

Connor JR, Patton SM, Oexle K, Allen RP. Iron and restless legs syndrome: treatment, genetics and pathophysiology // Sleep Med. 2017;31:61–70. doi: 10.1016/j.sleep.2016.09.009.

Högl B, Stefani A, Videnovic A. Restless legs syndrome: clinical diagnosis, pathophysiology and treatment // Lancet Neurol. 2018;17(8):717–728. doi: 10.1016/S1474-4422(18)30204-1

Garcia-Borreguero D, Kohnen R, Silber MH, et al. The long-term treatment of restless legs syndrome: evidence-based guidelines and clinical consensus best practice guidance // Sleep Med. 2017;29:1–12. doi: 10.1016/j.sleep.2016.08.005

Allen RP, Ondo WG, Ball E, Calloway MO, et al. Restless legs syndrome (RLS) augmentation associated with dopamine agonist and levodopa usage in a community sample // Sleep Med. 2011 May;12(5):431-9. doi: 10.1016/j.sleep.2011.03.003

Yeh PG, Spruyt K, DelRosso LM, Walters AS. A narrative review of the lesser-known medications for treatment of restless legs syndrome and pathogenetic implications // Nat Sci Sleep. 2023;15:7–25. doi: 10.2147/NSS.S391320

Pagani-Estévez GL, Silber MH, Carvalho DZ. Potential therapeutic benefit of spinal cord stimulation in restless legs syndrome: a scoping review and mechanistic considerations // Sleep Med Rev. 2023;67:101724. doi: 10.1016/j.smrv.2023.101724

Richards KC, Fry LM, Lozano AJ, Ji W, et al. Treatment of restless legs syndrome improves agitation and sleep in persons with dementia: a randomized trial // J Am Med Dir Assoc. 2025;26(5):105485. doi: 10.1016/j.jamda.2025.105485

Singh H, Baker FC, Ojile J, Adlou B, et al. Efficacy and safety of TOMAC for treatment of medication-naïve and medication-refractory restless legs syndrome: a randomized clinical trial and meta-analysis // Sleep Med. 2024;122:141-148. doi: 10.1016/j.sleep.2024.08.017

Winkelman JW, Armstrong MJ, Allen RP, Chaudhuri KR, Ondo WG, Trenkwalder C, Zee PC, Gronseth G, Gloss D, Zesiewicz TA. Practice guideline summary: Treatment of restless legs syndrome in adults // Neurology. 2016;87(24):2585–2593. doi: 10.1212/WNL.0000000000003388

Becker PM, Jamieson AO, Brown WD. Dopaminergic agents in restless legs syndrome and periodic limb movements of sleep: response and complications of extended treatment in 49 cases // Sleep. 1993;16(8):713–716

Bugnicourt J. Dopamine agonists in the treatment of restless legs syndrome: too much of a good thing? // J Sleep Med. 2024. doi: 10.13078/jsm.23003

Downloads

Published

31.12.2025

How to Cite

Ganizoda, M., Tolibova, L., Isrofilzoda, M., Asilova, N., & Kurbonova, M. (2025). Modern Approaches to The Treatment of Restless Legs Syndrome: The Role of Dopaminergic Drugs. National Journal of Neurology, 40–45. https://doi.org/10.61788/njn.v2i28.06

Issue

Section

Original Articles