From the Guidelines
Restless leg syndrome (RLS) should be treated with ferrous sulfate in adults with appropriate iron status, as suggested by the American Academy of Sleep Medicine (AASM) in their 2025 clinical practice guideline 1. The treatment of RLS involves a multifaceted approach, including lifestyle modifications and pharmacological interventions.
Key Recommendations
- Ferrous sulfate is recommended over no ferrous sulfate in patients with appropriate iron status 1, highlighting the importance of iron supplementation in managing RLS symptoms.
- Other treatment options, such as dipyridamole, extended-release oxycodone, and bilateral high-frequency peroneal nerve stimulation, may be considered based on individual patient needs and preferences 1.
Pharmacological Treatments
- Dopaminergic medications, such as levodopa, pramipexole, ropinirole, and rotigotine, may be used in specific cases, but their use is generally not recommended due to the risk of augmentation and other adverse effects 1.
- Alpha-2-delta calcium channel ligands, such as gabapentin, may be considered for patients with RLS and end-stage renal disease (ESRD) 1.
Special Considerations
- Patients with ESRD may require alternative treatment approaches, including IV iron sucrose and vitamin C supplementation 1.
- Children with RLS may benefit from ferrous sulfate supplementation, similar to adults 1.
Monitoring and Follow-up
- Regular follow-up is crucial to monitor symptom control, medication side effects, and adjust treatment plans as needed 1.
From the FDA Drug Label
The effectiveness of ropinirole in the treatment of RLS was demonstrated in randomized, double-blind, placebo-controlled trials in adults diagnosed with RLS using the International Restless Legs Syndrome Study Group diagnostic criteria Patients were required to have a history of a minimum of 15 RLS episodes/month during the previous month and a total score of ≥15 on the International RLS Rating Scale (IRLS scale) at baseline. In all 3 trials, a statistically significant difference between the treatment group receiving ropinirole and the treatment group receiving placebo was observed at Week 12 for both the mean change from baseline in the IRLS scale total score and the percentage of patients rated as responders (much improved or very much improved) on the CGI-I
Ropinirole is effective in the treatment of Restless Legs Syndrome (RLS), as demonstrated by a statistically significant difference in the mean change from baseline in the IRLS scale total score and the percentage of patients rated as responders on the CGI-I compared to placebo 2, 2.
- The mean dose at Week 12 was approximately 2 mg/day for the 3 trials.
- Patients continued on ropinirole demonstrated a significantly lower relapse rate compared with patients randomized to placebo. Key points:
- Ropinirole is effective in treating RLS
- Statistically significant difference in IRLS scale total score and CGI-I responders
- Mean dose at Week 12 was approximately 2 mg/day
- Lower relapse rate with continued ropinirole treatment
From the Research
Restless Leg Syndrome Treatments
- Non-pharmacological interventions such as repetitive transcranial magnetic stimulation, exercise, compression devices, counterstrain manipulation, infrared therapy, and standard acupuncture may be beneficial for reducing RLS severity 3
- Vibration pads, cryotherapy, yoga, compression devices, and acupuncture may improve some sleep-related outcomes in restless leg syndrome 3
- Regular physical activity should be recommended for the treatment of RLS symptoms 4
- Oral iron supplementation should be considered for people with RLS who have low ferritin levels 4
Pharmacological Treatments
- Dopaminergic agents are the best-studied agents and are considered first-line treatment of RLS 5
- Gabapentin is the most effective pharmacological intervention and may also improve sleep quality 6
- Pharmacologic options may be considered, including iron suppletion, an α2δ ligand, a dopamine agonist, a combination of an α2δ ligand and a dopamine agonist, or oxycodone/naloxone 7
Alternative Treatments
- Cool dialysate, intradialytic stretching exercise, and aromatherapy massage may be potential non-pharmacological interventions for RLS, but with limited confidence of evidence 6
- Insufficient evidence exists for yoga, acupuncture, pneumatic compression devices, near-infrared light therapy, cognitive-behavioral therapy, valerian, or Chinese herbs, but preliminary studies suggest that high-quality randomized controlled trials may be warranted 4