From the Guidelines
Muscle relaxants are not recommended as a first-line treatment for restless leg syndrome (RLS), and their use should be considered with caution due to potential side effects and limited evidence supporting their efficacy in RLS treatment. According to the American Academy of Sleep Medicine clinical practice guideline 1, there is no strong recommendation for the use of muscle relaxants in the treatment of RLS.
Some key points to consider when evaluating the use of muscle relaxants for RLS include:
- The potential for central nervous system adverse effects, such as sedation, dizziness, and dry mouth
- The lack of compelling evidence that skeletal muscle relaxants differ in efficacy or safety
- The association of certain muscle relaxants with risks for abuse and overdose, hepatotoxicity, or other serious adverse effects
Instead of muscle relaxants, the guideline recommends the use of other treatments, such as:
- Gabapentin enacarbil, gabapentin, or pregabalin, which have strong recommendations for use in adults with RLS 1
- IV ferric carboxymaltose or other iron supplements for patients with iron deficiency 1
- Dopamine agonists, such as pramipexole or ropinirole, although their use is conditional and depends on individual patient factors 1
When considering the use of muscle relaxants for RLS, it is essential to weigh the potential benefits against the risks and to carefully monitor patients for effectiveness and side effects. The use of muscle relaxants should be reserved for patients who have not responded to first-line treatments and should be initiated at the lowest effective dose, with gradual increases as needed and careful monitoring for adverse effects.
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.
Ropinirole is used to treat Restless Legs Syndrome (RLS). The drug has been shown to be effective in reducing symptoms of RLS, 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 2, 2.
- The recommended dosage is 0.25 mg once daily, titrated up to a maximum of 4 mg once daily based on clinical response and tolerability.
- Key benefits of ropinirole for RLS include:
- Reduction in symptoms of RLS
- Improvement in sleep quality
- Reduction in daytime somnolence
- Improvement in activities of daily living and mood associated with RLS
From the Research
Treatment Options for Restless Leg Syndrome
- Dopaminergic agents, such as levodopa, ropinirole, pramipexole, and rotigotine, are effective in the treatment of restless legs syndrome (RLS) and periodic limb movement disorder (PLMD) 3.
- Non-pharmacological interventions, including repetitive transcranial magnetic stimulation, exercise, compression devices, counterstrain manipulation, infrared therapy, and standard acupuncture, may be beneficial for reducing RLS severity and enhancing sleep 4.
- First-line management options for RLS include iron-replacement therapy, gabapentin, pregabalin, and dopamine agonists such as pramipexole, ropinirole, and rotigotine 5.
- Second-line therapies for RLS include intravenous iron infusion, opioids such as tramadol, oxycodone, and methadone 5.
Pharmacological Treatments
- Pregabalin, gabapentin enacarbil, and oxycodone/naloxone are considered efficacious for the treatment of RLS 6.
- Rotigotine, levodopa, ropinirole, pramipexole, cabergoline, and gabapentin are also considered efficacious for the treatment of RLS 6.
- Oral iron is not efficacious in iron-sufficient subjects, but its benefit for patients with low peripheral iron status has not been adequately evaluated 6.
Management of Augmentation
- Restless legs syndrome augmentation has been identified as a significant long-term treatment complication for pramipexole and possibly for all dopaminergic agents more than α2δ ligands 6.
- Special monitoring for augmentation is required for all dopaminergic medications, as well as tramadol 6.
- Other drugs, such as cabergoline, pergolide, oxycodone, methadone, tramadol, carbamazepine, and valproic acid, also require special safety monitoring 6.