From the Guidelines
The most effective treatment for restless legs syndrome (RLS) is the use of pregabalin, as recommended by the American Academy of Sleep Medicine (AASM) with a strong recommendation and moderate certainty of evidence 1.
Treatment Options for RLS
The treatment of RLS depends on the severity of symptoms and individual factors. The following options are recommended:
- Pregabalin: Recommended by the AASM with a strong recommendation and moderate certainty of evidence 1.
- Gabapentin: Recommended by the AASM with a strong recommendation and moderate certainty of evidence 1.
- Gabapentin enacarbil: Recommended by the AASM with a strong recommendation and moderate certainty of evidence 1.
- IV ferric carboxymaltose: Recommended by the AASM with a strong recommendation and moderate certainty of evidence for patients with appropriate iron status 1.
- Ferrous sulfate: Suggested by the AASM for patients with low ferritin levels (below 75 ng/mL) 1.
Special Considerations
- Opioids: May be considered for severe cases or those with inadequate response to other medications, with a conditional recommendation and moderate certainty of evidence 1.
- Bilateral high-frequency peroneal nerve stimulation: A new noninvasive nonpharmacological treatment, with a conditional recommendation and moderate certainty of evidence 1.
- Patients with end-stage renal disease (ESRD): Gabapentin, IV iron sucrose, and vitamin C are suggested with a conditional recommendation and moderate certainty of evidence 1.
Important Considerations
- Start with low doses and gradually increase as needed.
- Monitor for side effects like daytime sleepiness, impulse control disorders with dopamine agonists, or dependency with opioids and benzodiazepines.
- Treatment should be taken 1-2 hours before symptoms typically begin, usually in the evening.
From the FDA Drug Label
1.2 Restless Legs Syndrome Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). 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.
Recommended Medication for Restless Legs Syndrome (RLS):
- Ropinirole (PO) is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) 2, 2, 2.
- The medication has been shown to be effective in reducing symptoms of RLS in clinical trials, with a significant difference in mean change from baseline in the IRLS scale total score and percentage of patients rated as responders on the CGI-I compared to placebo.
- The dosage of ropinirole for RLS is initiated at 0.25 mg once daily and titrated based on clinical response and tolerability over 7 weeks to a maximum of 4 mg once daily.
From the Research
Medications for Restless Legs Syndrome
The following medications are recommended for treating restless legs syndrome (RLS):
- Dopaminergic agents, such as levodopa and dopamine agonists (e.g., ropinirole, pramipexole, cabergoline) 3, 4, 5
- Anticonvulsants, such as gabapentin 4, 5, 6
- Benzodiazepines, such as clonazepam 7
- Opioids, although these are generally considered second-line treatment 4
- Iron supplementation, which may be beneficial for some patients with RLS 5
First-Line Treatment
Dopaminergic agents, including ropinirole, are considered first-line therapy for RLS 3, 4, 5. Ropinirole has been shown to be effective in reducing symptoms of RLS and improving sleep quality 3, 5.
Second-Line Treatment
Gabapentin is considered a second-line treatment for RLS, but it has been shown to be effective in reducing symptoms and improving sleep quality in some patients 6, 7. Other second-line treatments include opioids and benzodiazepines 4, 7.
Special Considerations
In some cases, augmentation of RLS symptoms can occur with dopaminergic therapy, which may require a change in medication or the addition of other treatments 7. Additionally, certain antidepressants can exacerbate RLS symptoms, and alternative treatments such as agomelatine may be necessary 7.