Prevalence, Diagnosis, and Treatment Approaches for Restless Legs Syndrome

Shalini Paruthi, MD, FAASM

(Credit: AASM)

Adequate sleep is essential for overall health, safety, and well-being, standing as 1 of the 3 fundamental pillars of a healthy lifestyle alongside balanced nutrition and regular exercise.¹ For patients living with restless legs syndrome (RLS), however, achieving restorative sleep may be a significant challenge. The discomfort caused by the condition often disrupts the ability to fall or stay asleep, leading to chronic sleep deprivation and daytime fatigue. Over time, this sleep deficit can result in heightened irritability, impaired focus, and a diminished capacity to perform daily activities.

The widespread impact of RLS has been highlighted in recent studies. For example, a recent online survey conducted by the American Academy of Sleep Medicine (AASM) revealed that 13% of 2006 respondents reported an RLS diagnosis in the United States. Additionally, the “Patient ODYSSEY II Survey” by the RLS Foundation observed that patients with RLS experienced depression and anxiety at rates 4 times higher than the general population.¹ Therefore, these results emphasize the need for timely diagnosis and appropriate treatment to improve both sleep quality and overall well-being for those affected by RLS.

In response to this need, the AASM recently released updated clinical practice guidelines for the treatment of RLS in both adults and pediatric patients. The recommendations, published in the Journal of Clinical Sleep Medicine, were developed through a systematic review of current evidence to guide clinicians in delivering optimal care.² In line with these efforts, Shalini Paruthi, MD, FAASM, an AASM spokesperson and chair of the board of directors for the RLS Foundation, highlighted the clinical criteria used for diagnosing RLS in a recent interview with NeurologyLive^®. She also discussed how the condition presents differently across age groups and during pregnancy as well as highlighted the diagnostic challenges.

NeurologyLive: Can you provide an overview of the survey data on RLS in the United States?

Shalini Paruthi, MD, FAASM: It's very important to recognize that RLS affects about 13% of Americans. It occurs in all age groups, including children—about 2% of them meet the 4 clinical criteria for diagnosis. The prevalence increases slightly in middle adulthood, and during pregnancy, studies show that up to 80% of women may experience RLS symptoms. Later in life, around ages 55–60 and older, the prevalence can reach nearly 20%. Recognizing and appropriately diagnosing RLS is essential.

There are 4 clinical criteria for RLS diagnosis:

1. The urge to move: Most people report this urge in their legs, but it can also occur in other body parts. Up to 50% of individuals might experience restlessness in their arms, torso, or other areas.
2. Evening-worsened symptoms: The symptoms typically worsen in the evening, reflecting a circadian component.
3. Relief with movement: Activities like walking, stretching, rubbing legs, massaging, or taking warm baths often help alleviate symptoms.
4. Symptoms aggravated by rest: When individuals rest—such as after dinner, while watching TV, reading, or lying down at bedtime—symptoms often intensify, leading to insomnia for many.

When a patient comes to the clinic describing symptoms, what steps do you take to diagnose and treat them?

RLS is diagnosed based on the 4 clinical criteria, relying entirely on the patient’s description of their symptoms. It’s crucial to ask questions like, “Do you feel an urge to move your legs, particularly in the evening?” Patients might describe the sensations in various ways—“creepy-crawly feelings,” “rubber bands stretching,” “an achy feeling,” or even a painful variant of RLS.

Sometimes, these symptoms come up during discussions of other conditions, like neuropathy or chronic pain. It’s important to probe deeper to differentiate between RLS and other diagnoses. Since there’s no blood test or imaging for RLS, the diagnosis depends on eliciting a thorough clinical history.

What interventions or treatments do you recommend for patients with RLS symptoms?

Treatment depends on how much the symptoms affect the patient’s life. For occasional symptoms—occurring once every few months, for example—non-pharmacologic interventions may suffice. Patients can prepare for situations that might trigger symptoms, like long car or airplane rides, by using compression socks, scheduling movement breaks, or choosing aisle seats to allow easier mobility. Massage, warm baths, or evening walks can also help. Some patients find mental activities, such as crossword puzzles, useful for distraction.

When symptoms occur more frequently—multiple times a week, causing insomnia or significant distress—consultation with a primary care doctor, sleep physician, or neurologist may be necessary. Before considering medications, it’s essential to check iron stores. RLS is linked to dopamine dysregulation, and iron is a critical cofactor in dopamine production and transport. Testing iron levels (ferritin, total iron binding capacity, and iron saturation) is vital. If ferritin is below 50 ng/mL (or 75 ng/mL, per some guidelines), iron supplementation for at least 12 weeks is recommended. Patients should understand that improvement may take 4–6 weeks.

What are the pharmacologic options for RLS?

There are several medication classes for RLS:

• Alpha-2-delta ligands: Gabapentin, pregabalin, and gabapentin enacarbil are common choices. These should be taken about 1–2 hours before symptom onset.
• Dopamine agonists: While these are well-known in Parkinson treatment, they’re effective for RLS at much lower doses. For example, the maximum dose for ropinirole is 4 mg, and for pramipexole, it's 1 mg. However, dopamine agonists carry a risk of augmentation (symptoms worsening over time), affecting about 80% of patients after eight years.
• Opioids: For refractory cases, low-dose opioids like methadone (2.5–5 mg) can be effective and stable for long-term use.

We always consider adverse effects and the risk of dependence when choosing treatments.

Is there anything else you’d like to add?

One area of interest is RLS in children. Even children as young as 2 or 3 can describe symptoms if asked in a child-friendly way. Often, they might use terms like "hurts" instead of describing an urge to move. Parents might mistake symptoms for bedtime resistance or hyperactivity before bed. RLS in children is sometimes misdiagnosed as growing pains, but there’s significant overlap between the two. Supplementing iron in children with low iron stores has shown excellent results in alleviating both RLS and growing pains. This raises questions about whether growing pains might be a variant of RLS. As clinicians, we should be attentive to these symptoms in children and adults alike, as addressing them can significantly improve quality of life.

Transcript edited for clarity.

REFERENCES
1. Restless legs lead to restless nights: More than one in 10 Americans report having an RLS diagnosis. News Release. American Academy of Sleep Medicine (AASM). Published September 9, 2024. Accessed November 26, 2024. https://www.newswise.com/articles/restless-legs-lead-to-restless-nights-more-than-one-in-10-americans-report-having-an-rls-diagnosis
2. Winkelman JW, Berkowski JA, DelRosso LM, et al. Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. Published online September 26, 2024. doi:10.5664/jcsm.11390