From the Guidelines
Restless Legs Syndrome (RLS) should be treated with ferrous sulfate in patients 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 combination of lifestyle modifications and pharmacological interventions.
- Lifestyle modifications include:
- Establishing regular sleep patterns
- Avoiding caffeine and alcohol
- Exercising regularly during the day
- Using relaxation techniques like warm baths or leg massages before bedtime
- Pharmacological interventions include:
- Ferrous sulfate for patients with appropriate iron status, as it is suggested by the AASM 1
- Gabapentin, pregabalin, and IV ferric carboxymaltose are also recommended by the AASM in their 2025 guideline 1
- Extended-release oxycodone and other opioids may be used in adults with RLS, as suggested by the AASM 1
- Bilateral high-frequency peroneal nerve stimulation may also be used in adults with RLS, as suggested by the AASM 1 It is essential to note that the AASM suggests against the standard use of certain medications, including levodopa, pramipexole, transdermal rotigotine, ropinirole, bupropion, carbamazepine, clonazepam, and valproic acid, due to the potential for adverse effects or low certainty of evidence 1. Regular follow-up with healthcare providers is crucial to manage medication effectiveness and side effects, as RLS symptoms often worsen over time. The AASM also recommends regularly testing serum iron studies, including ferritin and transferrin saturation, to guide iron treatment decisions 1. Addressing exacerbating factors, such as alcohol, caffeine, and untreated obstructive sleep apnea, is also an essential step in the management of RLS 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. 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 Three of the controlled trials utilized the change from baseline in the IRLS scale at the Week 12 endpoint as the primary efficacy outcome.
The treatment options for Restless Legs Syndrome (RLS) include:
- Ropinirole: a dopamine agonist that has been shown to be effective in reducing symptoms of RLS, with a mean dose of approximately 2 mg/day.
- Flexible dosing: with patients initiating therapy at 0.25 mg ropinirole once daily and titrating based on clinical response and tolerability over 7 weeks to a maximum of 4 mg once daily.
- Long-term maintenance: of efficacy in the treatment of RLS was demonstrated in a 36-week trial 2.
From the Research
Treatment Options for Restless Legs Syndrome (RLS)
The treatment options for RLS can be categorized into pharmacologic and non-pharmacologic interventions.
- Pharmacologic treatments include:
- Non-pharmacologic treatments include:
- Lifestyle modifications, although there is insufficient evidence to recommend specific changes 3
- Iron supplementation, particularly for patients with iron deficiency 3, 5, 7, 6
- Mind-body interventions like yoga and acupuncture, although evidence is limited 7
- Alternative therapies such as pneumatic compression devices, light therapy, and cognitive-behavioral therapy, although evidence is insufficient 7
Considerations for Treatment
When selecting a treatment option, considerations should include:
- The severity of RLS symptoms 3, 4
- The presence of comorbidities such as depression, anxiety, or insomnia 4, 5
- The risk of augmentation, a paradoxical worsening of symptoms, particularly with dopaminergic medications 3, 5, 6
- The potential for rebound RLS and insomnia when discontinuing dopaminergic medications 5