Approach Considerations
Treatment for restless legs syndrome (RLS) may not be necessary for patients with mild or sporadic symptoms or for those without significant impairment. [4] Treatment should be tailored to the patient’s specific symptoms and may involve pharmacotherapy and nonpharmacologic measures. [4] Patients should be monitored by a neurologist or their primary care provider for development of adverse events, augmentation, or rebound.
In 2014, the US Food and Drug Administration (FDA) gave commercial clearance to the first device (Relaxis) for improvement of sleep quality in patients with primary RLS. The device, a vibrating pad, delivers vibratory counterstimulation to the patient’s legs as an individual lies in bed. Approval was based on 2 randomized studies that showed greater improvements in sleep quality with the device than with a placebo pad. [26]
Pharmacologic Therapy
Drug therapy for primary restless legs syndrome (RLS) is largely symptomatic; cure is possible only for secondary RLS. In some patients, RLS symptoms occur sporadically, with spontaneous remissions lasting weeks or months. The use of pharmacotherapy on an irregular basis is warranted in such cases. Continuous pharmacologic treatment should be considered if patients complain of having RLS symptoms at least 3 nights each week.
Medications used in the treatment of restless legs syndrome (RLS) include the following:
-
Benzodiazepines (eg, clonazepam)
-
Opioids (eg, codeine)
-
Anticonvulsants (eg, gabapentin [31] and pregabalin)
-
Presynaptic alpha2 -adrenergic agonists (eg, clonidine)
-
Iron salt
A Task Force of the International Restless Legs Syndrome Study Group (IRLSSG) has developed evidence-based guidelines for long-term pharmacologic treatment of RLS. [32] The Task Force reviewed the results of 61 studies and arrived at the following conclusions with respect to available medications:
-
Pregabalin - Effective for up to 1 year in treating RLS (evidence level, A).
-
Pramipexole, ropinirole, and rotigotine - Effective for up to 6 months in treating RLS (evidence level, A)
-
Gabapentin enacarbil (1 year), pramipexole (1 year), ropinirole (1 year), levodopa (2 years), and rotigotine (5 years) - Probably effective in treating RLS for durations ranging from 1 to 5 years (evidence level, B)
-
Pergolide and cabergoline - Because of associated safety concerns, not to be used in treating RLS unless the benefits clearly outweigh the risks
The IRLSSG Task Force recommends either a dopamine-receptor agonist or an alpha2-delta calcium-channel ligand as first-line treatment therapy for RLS in most patients, with the choice of medication depending on symptom severity, cognitive status, history, and comorbid conditions. [32]
All patients with low iron levels (ferritin < 50 ng/mL) should receive supplemental iron therapy. [4] In iron deficiency, 325 mg of ferrous sulfate may be given with 250 mg of vitamin C. Absorption is increased by taking this on an empty stomach and waiting 60 minutes before eating. Parenteral iron may also have a role in the treatment of RLS secondary to iron deficiency anemia. [33]
Anecdotal evidence from Japan suggests that yokukansan (an herbal remedy) may be effective in the treatment of RLS. [34] Oral corticosteroids have also been used to treat RLS in exceptional circumstances. [35] Currently, steroids and yokukansan are not approved by the US Food and Drug Administration (FDA) as therapy for RLS.
No specific recommendations or FDA-approved medications exist for the treatment of RLS in children. Children with low serum ferritin (< 50 ng/mL) should be treated with supplemental iron therapy. Dopaminergic therapy was found to be effective in small series in children with RLS.
Nonpharmacologic Therapy
Sleep hygiene measures should be recommended to all patients. Moreover, patients with mild restless legs syndrome (RLS) who are sensitive to caffeine, alcohol, or nicotine should avoid these substances. Offending medications (eg, selective serotonin reuptake inhibitors [SSRIs], diphenhydramine, and dopamine antagonists) also should be discontinued when it is possible to do so.
Exercise may be helpful for some patients [36] ; however, this potential benefit has not been systematically studied. In general, physical measures are only partially or temporarily helpful and should be avoided before bedtime. Some patients benefit from different physical modalities before bedtime, such as a hot or cold bath, a whirlpool bath, limb massage, or vibratory or electrical stimulation of the feet and toes.
Nonpharmacologic management and sleep hygiene measures are the treatments of choice in children. A regular sleep/wake schedule and the elimination of stimulating activity and caffeine before bedtime are important measures.
