From the Guidelines
The most effective treatment for restless leg syndrome (RLS) is the use of gabapentin enacarbil, gabapentin, or pregabalin, as recommended by the American Academy of Sleep Medicine (AASM) with strong evidence and moderate certainty 1.
Treatment Approach
The treatment of RLS typically begins with lifestyle modifications and addressing underlying causes, such as maintaining regular sleep habits, avoiding caffeine and alcohol, exercising regularly, and treating iron deficiency if present.
- For medication therapy, gabapentin enacarbil, gabapentin, or pregabalin are recommended as first-line options due to their strong recommendation and moderate certainty of evidence 1.
- Additionally, IV ferric carboxymaltose is recommended for patients with appropriate iron status, with strong evidence and moderate certainty 1.
Special Considerations
- In adults with RLS and end-stage renal disease (ESRD), the AASM suggests the use of gabapentin over no gabapentin, with conditional recommendation and very low certainty of evidence 1.
- The AASM also suggests against the standard use of certain medications, including levodopa, pramipexole, rotigotine, and ropinirole, due to concerns about augmentation and adverse effects with long-term use 1.
Individualized Treatment
Treatment should be individualized based on symptom severity, comorbidities, and patient preferences. Patients should also be evaluated for conditions that can exacerbate RLS, including peripheral neuropathy, kidney disease, and certain medications like antidepressants and antihistamines.
- Medication rotation may be necessary for patients who experience augmentation or adverse effects with long-term use of dopamine agonists 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.
The recommended treatment for Restless Leg Syndrome (RLS) is ropinirole, with a starting dose of 0.25 mg once daily, titrated based on clinical response and tolerability over 7 weeks to a maximum of 4 mg once daily. The dose should be taken between 1 and 3 hours before bedtime. 2 2
- Key points:
- Initiate therapy at 0.25 mg once daily
- Titrate based on clinical response and tolerability over 7 weeks
- Maximum dose of 4 mg once daily
- Take dose between 1 and 3 hours before bedtime
From the Research
Treatment Options for Restless Leg Syndrome
The recommended treatment for restless leg syndrome (RLS) depends on the severity of symptoms and their impact on the patient's quality of life.
- Pharmacological treatment should be limited to patients with clinically relevant RLS, where symptoms impair quality of life, daytime functioning, social functioning, or sleep 3.
- Treatment on demand is a clinical need in some RLS patients, and medications include carbidopa/levodopa, pramipexole, ropinirole, oxycodone, methadone, codeine, and tramadol 3.
- Chronic RLS should be treated with either a nonergot dopamine agonist or an α-2-δ calcium channel ligand 3.
Choosing the Right Medication
The choice of medication depends on various factors, including the presence of comorbidities such as depression, anxiety, and insomnia.
- A dopamine agonist is a more appropriate choice in the presence of depression and overweight 3.
- α-2-δ ligands can alleviate chronic pain and may be helpful in treating anxiety and insomnia, making them a suitable choice for patients with these comorbidities 3.
- For RLS present throughout the day and night, the use of long-acting agents, such as the rotigotine patch or gabapentin enacarbil, should be considered 3.
Managing Augmentation
Augmentation is a common issue in RLS treatment, particularly with dopamine agonists.
- If dopamine agonists are used to treat RLS, it is recommended that the dosage should be kept as low as possible without exceeding the maximum dose recommended for RLS treatment 4.
- Medications that are effective and have little risk of augmentation, such as alpha-2-delta ligands, may be considered for initial RLS treatment 4.
- In refractory RLS, oral prolonged release oxycodone-naloxone should be considered 3.
Role of Opioids in RLS Treatment
Opioids can be used as monotherapy or add-on treatment for RLS, particularly in severe cases.