What is the recommended treatment for restless legs syndrome?

From the Guidelines

The recommended treatment for restless legs syndrome (RLS) is to use ferrous sulfate over no ferrous sulfate in patients with appropriate iron status, as suggested by the American Academy of Sleep Medicine (AASM) 1.

Key Considerations

• The AASM suggests the use of ferrous sulfate in adults with RLS, with a conditional recommendation and moderate certainty of evidence 1.
• Other treatment options, such as dipyridamole, extended-release oxycodone, and bilateral high-frequency peroneal nerve stimulation, may also be considered, but with varying levels of certainty and recommendation strength 1.
• The use of certain medications, such as levodopa, pramipexole, and ropinirole, is not recommended as a standard treatment for RLS due to concerns about augmentation and adverse effects with long-term use 1.

Treatment Approach

• Lifestyle modifications, such as maintaining regular sleep habits, avoiding caffeine and alcohol, and exercising moderately, should be encouraged as part of the treatment approach.
• Iron supplementation, typically with ferrous sulfate 325 mg daily and vitamin C, is recommended for patients with low ferritin levels below 75 ng/mL.
• Medication therapy should be individualized, starting with the lowest effective dose to minimize side effects, and may include dopamine agonists, alpha-2-delta calcium channel ligands, or low-dose opioids.

Special Populations

• In adults with RLS and end-stage renal disease (ESRD), the AASM suggests the use of gabapentin, IV iron sucrose, and vitamin C, with conditional recommendations 1.
• In children with RLS, the use of oral iron supplementation is recommended, with consideration of potential side effects and the need for individualized treatment 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. All trials employed flexible dosing, with patients initiating therapy at 0.25 mg ropinirole once daily. Patients were titrated based on clinical response and tolerability over 7 weeks to a maximum of 4 mg once daily. The mean dose at Week 12 was approximately 2 mg/day for the 3 trials.

The recommended treatment for Restless Legs Syndrome (RLS) is ropinirole, with a starting dose of 0.25 mg once daily, titrated based on clinical response and tolerability over 7 weeks to a maximum of 4 mg once daily. The mean dose at Week 12 was approximately 2 mg/day. Key points:

• Flexible dosing: Patients initiate therapy at 0.25 mg ropinirole once daily.
• Titration: Patients are titrated based on clinical response and tolerability over 7 weeks to a maximum of 4 mg once daily.
• Dosing time: All doses are taken between 1 and 3 hours before bedtime. 2

From the Research

Treatment Options for Restless Legs Syndrome

The treatment of restless legs syndrome (RLS) can be managed through various approaches, including non-pharmacological measures, first-line management options, and second-line therapies.

• Non-pharmacological measures: Some people with RLS have adequate symptom control with non-pharmacological measures such as massage or temperate baths 3.
• First-line management options: First-line management options include iron-replacement therapy in those with evidence for reduced body-iron stores or, alternatively, with prescribed gabapentin or pregabalin, and dopamine agonists such as pramipexole, ropinirole, and rotigotine 3, 4.
• Second-line therapies: Second-line therapies include intravenous iron infusion in those who are intolerant of oral iron and/or those having augmentation with intense, severe RLS symptoms, and opioids including tramadol, oxycodone, and methadone 3, 5.

Alternative Treatment Approaches

Alternative treatment approaches for RLS include mind-body interventions, lifestyle interventions, and neutraceuticals.

• Mind-body interventions: Regular physical activity should be recommended for the treatment of RLS symptoms 6.
• Lifestyle interventions: Oral iron supplementation should be considered for people with RLS who have low ferritin levels 6.
• Neutraceuticals: Supplementation for low levels of vitamins E, C, and D could be considered, although evidence specifically in RLS is limited 6.

Management of RLS

The management of RLS is considered under various headings, including general considerations, intermittent RLS, chronic persistent RLS, refractory RLS, special circumstances, and alternative, investigative, and potential future therapies.

• General considerations: Nonpharmacologic approaches, including mental alerting activities, avoidance of substances or medications that may exacerbate RLS, and oral and intravenous iron supplementation, are outlined 7.
• Choice of therapy: The choice of an alpha2-delta ligand as first-line therapy for chronic persistent RLS with dopamine agonists as a second-line option is explained 7.
• Refractory RLS: Refractory RLS is defined and management approaches, including combination therapy and the use of high-potency opioids, are described 7.