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

From the Guidelines

Treatment of restless leg syndrome (RLS) should prioritize the use of ferrous sulfate over no ferrous sulfate in patients with appropriate iron status, as suggested by the American Academy of Sleep Medicine (AASM) with moderate certainty of evidence 1. The AASM also suggests the use of gabapentin enacarbil, gabapentin, and pregabalin as first-line treatments for adults with RLS, with strong recommendations and moderate certainty of evidence 1. Key considerations in the treatment of RLS include:

• Maintaining regular sleep habits and avoiding caffeine, alcohol, and nicotine
• Engaging in moderate exercise
• Iron supplementation with ferrous sulfate 325 mg taken with vitamin C to enhance absorption, for patients with ferritin levels below 75 ng/mL
• First-line medication options:
  • Gabapentin enacarbil
  • Gabapentin (300-1200 mg daily)
  • Pregabalin (75-300 mg daily)
• Rotation of medications periodically to avoid augmentation (worsening symptoms) with long-term dopaminergic therapy
• Non-pharmacological approaches like pneumatic compression devices, vibration therapy, or cognitive behavioral therapy for additional relief
• Individualized treatment based on symptom severity, comorbidities, and patient preferences, with regular follow-up to assess efficacy and side effects. It is essential to note that the AASM suggests against the standard use of certain medications, including levodopa, pramipexole, ropinirole, and valproic acid, due to concerns about augmentation and adverse effects 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. Patients with RLS secondary to other conditions (e.g., pregnancy, renal failure, anemia) were excluded. 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. All doses were taken between 1 and 3 hours before bedtime.

The treatment guidelines for restless leg syndrome (RLS) using ropinirole involve:

• Flexible dosing: starting at 0.25 mg once daily and titrating up to a maximum of 4 mg once daily based on clinical response and tolerability.
• Initiation: patients should initiate therapy at 0.25 mg ropinirole once daily.
• Dose adjustment: doses should be adjusted over 7 weeks.
• Administration: all doses should be taken between 1 and 3 hours before bedtime.
• Patient selection: patients should have a history of a minimum of 15 RLS episodes/month and a total score of ≥15 on the International RLS Rating Scale (IRLS scale) at baseline 2.

From the Research

Treatment Guidelines for Restless Leg Syndrome

• The management of restless legs syndrome (RLS) involves a combination of nonpharmacologic and pharmacologic approaches 3.
• Nonpharmacologic approaches include mental alerting activities, avoidance of substances or medications that may exacerbate RLS, and oral and intravenous iron supplementation 3, 4.
• 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 3.
• Dopamine agonists, such as pramipexole and ropinirole, are considered first-line treatment for RLS and have been shown to improve symptoms and suppress periodic leg movements during sleep 5, 6, 7.
• Alternative treatments, including mind-body interventions, lifestyle interventions, and neutraceuticals, may be considered for patients who do not respond to conventional pharmacologic treatment or who prefer alternative approaches 4.

Pharmacologic Treatment

• Dopamine agonists, such as pramipexole and ropinirole, are the most commonly used pharmacologic treatments for RLS 5, 6, 7.
• Alpha2-delta ligands, such as gabapentin and pregabalin, may be used as first-line therapy for chronic persistent RLS 3.
• Opioids, such as oxycodone and tramadol, may be used for refractory RLS, but their use is limited due to the risk of addiction and other side effects 3.

Nonpharmacologic Treatment

• Regular physical activity, such as walking or stretching, may help alleviate RLS symptoms 4.
• Oral iron supplementation may be beneficial for patients with low ferritin levels 4.
• Avoidance of substances or medications that may exacerbate RLS, such as caffeine and nicotine, is recommended 3, 4.
• Mental alerting activities, such as reading or puzzles, may help reduce symptoms of RLS 3.