A new clinical practice guideline offers updated treatment suggestions for restless legs syndrome (RLS), spotlighting significant shifts in the conventional care for adults affected by this condition.
A new clinical practice guideline developed by the American Academy of Sleep Medicine provides updated recommendations for the treatment of restless legs syndrome. The guideline reflects the latest scientific evidence and recommends significant changes in the standard treatment of RLS in adults.
The guideline, now available online in the Journal of Clinical Sleep Medicine, serves as an update to the AASM’s previous recommendations from 2012. The authors emphasized that multiple clinical trials and comprehensive studies over the past ten years have provided essential evidence that underpins these new guidelines.
According to Dr. John Winkelman, chair of the AASM task force and professor at Harvard Medical School, “This new clinical practice guideline from the AASM marks a significant milestone in RLS treatment for adults. We have harnessed the latest scientific evidence to offer recommendations that can enhance healthcare providers’ ability to deliver patient-focused care for individuals with RLS.”
RLS is a movement disorder linked to sleep that induces a strong, almost uncontrollable need to move the legs, often accompanied by unpleasant sensations in those limbs. Symptoms typically start or intensify during rest or inactivity and can be temporarily relieved through movement, primarily occurring in the evening or at night. This disorder can lead to sleep disruption, emotional distress, and a decrease in daily functioning.
A key update in the new guideline is the increased emphasis on checking iron levels in all individuals with RLS, recommending iron supplements based on these evaluations. This change stems from evidence indicating that low iron levels in the brain may significantly contribute to RLS. For adults suffering from RLS, there is a strong recommendation for the use of intravenous ferric carboxymaltose, along with conditional recommendations for two other forms of intravenous iron and one oral variant—ferrous sulfate. For pediatric patients, only ferrous sulfate is conditionally recommended as a treatment choice.
In this context, a “strong” recommendation suggests that healthcare providers should generally adhere to this guidance, while a “conditional” recommendation indicates a need for clinical judgment considering individual patient values and preferences.
Another notable shift is the guideline’s conditional recommendations against routinely using pramipexole and ropinirole, which had previously received strong endorsements in 2012. Recent studies have indicated that long-term usage of these dopamine agonists can lead to a phenomenon known as “augmentation,” where RLS symptoms progressively worsen over time.
Conversely, new findings supporting three alpha-2-delta ligand calcium channel blockers—specifically gabapentin enacarbil, gabapentin, and pregabalin—have led the task force to endorse them as strong treatment options. These medications do not exhibit the negative symptom exacerbation linked to dopaminergic agents.
Additionally, an innovative treatment method—bilateral high-frequency peroneal nerve stimulation—garnered a conditional recommendation. This approach uses a wearable device to stimulate leg nerves prior to bedtime.
Low-dose, extended-release oxycodone, along with other low-dose opioids, also received conditional support. While low-dose opioids have shown effectiveness for RLS, their usage carries risks that necessitate careful monitoring. A national RLS opioid registry at Massachusetts General Hospital is ongoing, gathering long-term data to evaluate the safety, stability, and efficacy of these opioid medications for RLS.
The guideline advises that the initial step in handling RLS should focus on managing aggravating factors such as alcohol consumption, caffeine intake, certain antidepressants, antihistamines, and untreated obstructive sleep apnea. It also notes that RLS frequently occurs during pregnancy.
To create the guideline, the AASM assembled a task force composed of sleep medicine professionals with expertise in RLS. They formulated 28 clinical practice recommendations based on a thorough review of existing literature and the GRADE assessment process, which weighed evidence quality, positive and negative outcomes, patient preferences, and resource allocation.
