What are the treatment options for Restless Legs Syndrome (RLS)?

From the Guidelines

Restless leg syndrome can be effectively managed through a combination of lifestyle changes and medications, with the most recent guidelines suggesting the use of ferrous sulfate, gabapentin, and pregabalin as primary treatment options. For mild symptoms, start with lifestyle modifications such as establishing a regular sleep schedule, avoiding caffeine and alcohol, engaging in moderate daily exercise, and practicing relaxation techniques like yoga or meditation. Warm baths, leg massages, and alternating hot and cold packs may also provide relief. If iron deficiency is present (a common underlying cause), iron supplements like ferrous sulfate 325mg daily with vitamin C to enhance absorption may be recommended, as suggested by the American Academy of Sleep Medicine (1).

For moderate to severe symptoms that impact quality of life, medications can help. The AASM recommends the use of gabapentin enacarbil, gabapentin, and pregabalin as first-line options (1). These medications work by regulating calcium channels and addressing the neurological basis of the condition. In adults with RLS, the AASM suggests the use of extended-release oxycodone and other opioids over no opioids, but with caution due to addiction risks (1).

Some key points to consider when treating restless leg syndrome include:

• The use of ferrous sulfate in patients with appropriate iron status (1)
• The recommendation against the standard use of levodopa, pramipexole, and ropinirole due to concerns about augmentation (1)
• The suggestion against the use of valproic acid, carbamazepine, and clonazepam due to low certainty of evidence or potential adverse effects (1)
• The recommendation for the use of gabapentin, pregabalin, and IV ferric carboxymaltose in adults with RLS (1)

Overall, the treatment of restless leg syndrome should prioritize the use of evidence-based medications and lifestyle modifications to improve quality of life and reduce symptoms, as supported by the most recent guidelines (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. A variety of measures were used to assess the effects of treatment, including the IRLS scale and Clinical Global Impression-Global Improvement (CGI-I) scores 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

Restless Leg Treatment Options:

• Ropinirole (PO) is a treatment option for Restless Legs Syndrome (RLS)
• The recommended dosage is 0.25 mg once daily, titrated based on clinical response and tolerability over 7 weeks to a maximum of 4 mg once daily
• Key Benefits:
  • Statistically significant difference in mean change from baseline in IRLS scale total score
  • Statistically significant difference in percentage of patients rated as responders on CGI-I
  • Long-term maintenance of efficacy in the treatment of RLS was demonstrated in a 36-week trial 2, 2

From the Research

Restless Leg Treatment Options

• Pharmacological treatment options include dopaminergic agents, such as levodopa and dopamine agonists, which are considered first-line treatment for RLS 3, 4, 5.
• Dopamine agonists, including pramipexole, ropinirole, and cabergoline, have been shown to alleviate RLS symptoms in 70 to 100% of patients 4.
• Non-pharmacological treatment options include lifestyle interventions, such as regular physical activity, which should be recommended for the treatment of RLS symptoms 6.
• Alternative practices, such as mind-body interventions (yoga, acupuncture), non-pharmacologic lifestyle interventions (pneumatic compression devices, light therapy, cognitive-behavioral therapy), and neutraceuticals (vitamins, valerian, Chinese herbs) may be considered, although evidence is limited or insufficient 6.
• Oral iron supplementation should be considered for people with RLS who have low ferritin levels, and supplementation for low levels of vitamins E, C, and D may also be considered, although evidence is limited 6.

Treatment Considerations

• Treatment should be limited to patients who suffer from clinically relevant RLS with impaired sleep quality or quality of life 3.
• A treatment on demand may be necessary for RLS cases that present intermittent symptoms 3.
• Augmentation, a common adverse effect of levodopa treatment, can be mild and responsive to additional dosing with dopamine agonists 4.