Treatment for restless legs syndrome. What are the options?

Treatment depends on severity — and the landscape has changed

Restless legs syndrome (RLS) is one of the more frustrating conditions I treat. The urge to move your legs — that creeping, crawling, uncomfortable sensation that arrives just as you’re trying to settle down for the night — can make falling asleep feel impossible. And because the symptoms ease with movement, you end up pacing the house at 2am instead of sleeping.

The good news is that we now have a much clearer picture of which treatments work, which ones carry hidden risks, and how to approach treatment in a logical, stepwise way. In January 2025, the American Academy of Sleep Medicine (AASM) published updated clinical practice guidelines for the treatment of RLS, and these have prompted a significant shift in how we approach medication choices — particularly moving away from dopamine agonists and giving greater emphasis to iron replacement, gabapentinoids, and opioids.

Which treatment strategy makes sense for you depends on how severe your symptoms are, how much they’re affecting your sleep and quality of life, and what other medical conditions you might have.

What can I do without medication?

For most people who get RLS symptoms occasionally or only have relatively mild symptoms, non-drug strategies can work well. People respond differently to different approaches, so if one doesn’t help, it’s worth trying others.

Iron replacement: This is the single most important first step for anyone with clinically significant RLS. There is strong evidence that low iron stores — measured by testing blood levels of ferritin and transferrin saturation — can trigger or worsen RLS symptoms. The AASM guideline makes this a ‘good practice statement,’ meaning it applies to everyone with RLS regardless of severity. The thresholds for people with RLS are different from the general population: intravenous (IV) iron is recommended if ferritin is ≤75 ng/mL or transferrin saturation is less than 20%. There is also some suggestion that iron supplementation, which can be IV or oral supplements, when ferritin is over 75ng/mL can help restless legs symptoms.

Iron testing should ideally be done in the morning, and you should avoid iron-containing supplements and foods for at least 24 hours beforehand to get an accurate result. Oral iron can work, but is poorly absorbed when ferritin is already above 50–75 ng/mL and can cause constipation. IV iron infusion — particularly ferric carboxymaltose (Ferinject) — has the strongest evidence, with the AASM giving it a strong recommendation based on multiple randomised controlled trials showing improvements in symptom severity, sleep quality, and quality of life.

Avoiding caffeine: Some people find that caffeine worsens their RLS symptoms. Caffeine is also found in chocolate, and I’ve seen a few people who’ve had notable improvements in RLS since cutting out evening chocolate.

Movement and pacing: RLS symptoms almost always improve with movement. Some people find that getting up and walking around settles their symptoms enough to then get off to sleep. Walking barefoot on a cool floor — tiles or slate — seems to help some people, as the temperature change also reduces symptoms.

Massage: In some cultures, family members massaging the legs of the person with RLS symptoms is a common and effective strategy. Leg massage can provide temporary relief, particularly when symptoms flare up in the evening.

Mindfulness: There is good evidence for using mindfulness-based approaches in both pain and insomnia, and with RLS having features of each — leg discomfort and disturbed sleep — it makes sense that mindfulness could be helpful. We conducted a pilot study using mindfulness-based stress reduction in people with severe RLS and showed it was effective at reducing symptom severity, with improvements in sleep quality and quality of life (Bablas et al, Mindfulness 2016; 7:396–408). All participants had very severe RLS, so the aim was to reduce rather than eliminate symptoms. This work has since prompted other groups to explore mindfulness-based interventions for RLS, and a randomised controlled trial in haemodialysis patients has shown similar benefits.

Paracetamol: There isn’t a formal evidence base for paracetamol in RLS, and it doesn’t appear in clinical guidelines. However, a number of people tell me they find low-dose paracetamol (500–1000 mg at night) helpful. Given the relatively low risk of paracetamol at these doses, it can be a reasonable option to try for mild symptoms, but I wouldn’t consider it a primary treatment.

Magnesium: Magnesium supplements are widely promoted for RLS and leg cramps. I’ve seen some people respond well to magnesium supplementation, but the evidence base is very limited — one of the few studies in this area was published back in 1998. It’s unlikely to cause harm at standard doses, so it’s reasonable to try, but I wouldn’t rely on it as a primary strategy.

Addressing exacerbating factors: The 2025 AASM guideline emphasises that the first step in management should be identifying and addressing factors that can worsen RLS. These include alcohol, caffeine, and a range of medications — particularly antihistamines (commonly found in over-the-counter sleep aids), antidepressants (most serotonergic antidepressants can worsen RLS), and antidopaminergic medications (such as some anti-nausea drugs). Untreated obstructive sleep apnoea can also exacerbate RLS and should be addressed.

What medications are used for RLS?

The medication landscape for RLS has shifted considerably. The 2025 AASM guideline now strongly recommends gabapentinoids as first-line drug treatment and has moved dopamine agonists to a ‘conditional recommendation against standard use.’ This is a major change that reflects growing evidence about the long-term risks of dopamine agonists, particularly augmentation — where the medication itself gradually worsens the condition it’s supposed to treat.

Alpha-2-delta calcium channel ligands — gabapentin and pregabalin: These are now the first-line drug treatment for RLS. The AASM gives a strong recommendation for gabapentin (Neurontin), gabapentin enacarbil (not available in Australia), and pregabalin (Lyrica). Multiple randomised controlled trials show they are effective at reducing RLS symptom severity, with moderate effect sizes. They also improve sleep quality.

Side effects include drowsiness and dizziness, which can sometimes be useful when taken at bedtime. Unlike dopamine agonists, gabapentinoids do not cause augmentation. However, there is emerging evidence of misuse potential in people with opioid use disorder, and caution is needed in people with untreated obstructive sleep apnoea as they can contribute to respiratory depression when combined with other sedating medications.

In Australia, neither gabapentin or pregabalin are PBS-listed for RLS, which means there is an out-of-pocket cost. Despite this, they remain my preferred first-line medication for RLS because of their strong evidence base and favourable long-term safety profile compared to dopamine agonists.

Opioids — for moderate to severe and refractory RLS: The 2025 AASM guideline gives a conditional recommendation for extended-release oxycodone and other opioids for RLS. This represents a notable change — opioids are now positioned higher in the treatment hierarchy than dopamine agonists, reflecting growing recognition that low-dose opioids can be safe and effective for RLS when used appropriately.

Opioids are particularly valuable for people with severe RLS that doesn’t respond to gabapentinoids, and for managing augmentation symptoms during the process of tapering off dopamine agonists. Long-term observational studies suggest that the risks of abuse and dose escalation are relatively low in RLS populations when patients are appropriately screened.

My personal preference is buprenorphine, which can be used as a patch or as sublingual tablets. Buprenorphine has a ceiling effect on respiratory depression, meaning it is safer from a breathing standpoint than most other opioids — an important consideration given that many people with RLS also have obstructive sleep apnoea. Various opioids are used in practice, and selection is tailored to the individual based on their side-effect profile and other health conditions.

Dopamine agonists — pramipexole, ropinirole, rotigotine: why we’ve moved away from them: For many years, dopamine agonists were the mainstay of RLS treatment. They can be very effective at reducing symptoms in the short term. However, the 2025 AASM guideline now recommends against their standard use, and I agree with this position based on my own clinical experience.

The two main concerns are:

• Augmentation: This is where the medication itself gradually worsens RLS symptoms over months to years. Symptoms start appearing earlier in the day, come on sooner with sitting, and can spread to the arms. Augmentation is common with long-term dopamine agonist use, and once it develops, it can be very difficult to manage — often requiring a challenging withdrawal process.
• Impulse control disorders: Dopamine agonists can trigger compulsive behaviours including gambling, excessive spending, risk-taking, and hypersexuality. In research we published in 2011, we identified cases of impulse control disorders in people taking dopamine agonists for RLS (Dang, Cunnington & Swieca, Clinical Neuropharmacology 2011; 34(2):66–70). These behaviours can be devastating and may not be recognised as medication-related.

The guideline does note that dopamine agonists may still be considered in limited circumstances — for example, short-term use during situations where you need to sit still for long periods (flights, theatre) — but they are no longer considered appropriate for routine, ongoing use. If you are currently taking a dopamine agonist, don’t stop it abruptly, as this can cause severe rebound symptoms. Talk to your doctor about a gradual tapering plan.

Levodopa: Levodopa (Madopar, Sinemet) was one of the first medications used for RLS and the AASM now recommends against its standard use due to a high risk of augmentation. Of all the dopaminergic medications, levodopa appears to carry the greatest augmentation risk when used regularly. It may have a role for very occasional, as-needed use — for example, a single dose before a long flight — but it’s not suitable for regular treatment.

Clonazepam: Clonazepam was commonly used for leg movements during sleep for many years. However, the AASM now recommends against its use for RLS, citing very low certainty of evidence for benefit and concerns about side effects including sedation, cognitive impairment, and dependence. It is no longer part of my treatment approach for RLS.

What about non-drug devices?

Tonic motor activation (TOMAC): TOMAC is a newer non-drug treatment that has received a conditional recommendation from the AASM. It’s a wearable device placed below the knees that delivers electrical stimulation to the peroneal nerve, causing sustained, low-level muscle activation in the lower legs — essentially mimicking the movement that naturally relieves RLS symptoms.

Randomised controlled trials in people with medication-refractory RLS have shown clinically meaningful reductions in symptom severity, and the device appears to be well tolerated with no serious side effects. A 24-week extension study suggests benefits are durable and may even improve over time. The Nidra TOMAC system received FDA approval in the United States in April 2023 and has been granted dedicated reimbursement codes there.

TOMAC is not currently available in Australia — it operates on a subscription model in the US only. However, it represents an exciting development for people with severe, medication-refractory RLS, and I expect we will see it become available more broadly in the coming years. It’s particularly appealing because it avoids the risks of augmentation, impulse control disorders, and the other side effects associated with pharmacological treatments.

How do I approach treatment at different levels of severity?

Regardless of severity, everyone with RLS should have their iron levels checked and optimised (ferritin >75 ng/mL), and potential exacerbating factors — particularly medications — should be reviewed.

Mild or intermittent symptoms: I’ll generally focus on non-drug strategies — ensuring iron stores are adequate, avoiding caffeine and other triggers, and using movement-based approaches. If medication is needed occasionally, I might use a gabapentinoid on an as-needed basis.

Moderate symptoms most nights: In addition to non-drug strategies, I’ll typically start regular medication with gabapentin or pregabalin. These are now clearly the first-line drug treatment based on the updated guidelines.

Severe or refractory symptoms: For people whose symptoms don’t respond adequately to gabapentinoids, I’ll add a low-dose opioid — my preference being buprenorphine. For those who have developed augmentation on dopamine agonists, the process involves adding an alternative treatment (gabapentinoid and/or opioid) and then gradually tapering the dopamine agonist while monitoring for rebound symptoms. This transition can be challenging and generally requires specialist supervision.

What about RLS in pregnancy?

RLS is common in pregnancy, and treatment options are more limited due to safety considerations. The AASM guideline specifically notes that clinicians should consider the pregnancy-specific safety profile of each treatment. Iron supplementation — if ferritin is low — remains the safest starting point. Non-drug strategies become particularly important in pregnancy. Any medication decisions should be made in close consultation with your treating obstetrician and sleep specialist.

Related posts and links:

• What is restless legs syndrome?
• Augmentation in restless legs syndrome
• SleepHub podcast episode on restless legs syndrome
• AASM 2025 Clinical Practice Guideline for RLS treatment
• RLS Foundation — treatment information

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