How common is it for a 62‑year‑old woman with restless‑legs syndrome (RLS) to remain on a daily ropinirole 4 mg dose for many years?

Long-Term Ropinirole Use for RLS: Prevalence and Current Evidence

A 62-year-old woman remaining on ropinirole 4 mg daily for years represents an outdated treatment pattern that current guidelines explicitly recommend against due to high augmentation risk; this scenario is becoming increasingly uncommon as clinical practice shifts toward alpha-2-delta ligands as first-line therapy. 1

Historical Context vs. Current Guidelines

Why This Was Common in the Past

• Ropinirole received FDA approval for RLS and was widely prescribed as first-line therapy before 2025, with the approved titration schedule escalating from 0.25 mg to a maximum of 4 mg daily over 7 weeks 2, 1
• Older studies (2002–2013) reported that dopamine agonists including ropinirole alleviated RLS symptoms in 70–100% of patients, leading to widespread adoption 3, 4
• A 2013 trial demonstrated efficacy at doses up to 4 mg daily in patients with severe RLS (IRLS scores ≥24), with reported augmentation rates of only ≤4% during the 26-week study period 4

Why This Is Now Discouraged

• The 2025 American Academy of Sleep Medicine guidelines issue a conditional recommendation with moderate certainty of evidence AGAINST the standard use of ropinirole for RLS 1
• The guideline explicitly advises clinicians not to increase ropinirole from 0.25 mg to 0.5 mg and instead recommends transitioning patients to alpha-2-delta ligands (gabapentin, gabapentin enacarbil, or pregabalin) 1
• Augmentation—a paradoxical worsening of RLS with earlier daily onset, increased intensity, and spread to arms or trunk—occurs in a substantial proportion of patients on long-term dopamine agonist therapy, with an annual incidence of 7–10% 1
• Older levodopa studies reported augmentation rates as high as 82%, and while initial ropinirole trials suggested lower rates, longer-term observational data reveal clinically significant augmentation risk 3, 1

Clinical Reality of Long-Term Ropinirole Use

Augmentation Phenomenon

• Augmentation typically manifests as symptoms beginning earlier in the day (afternoon instead of evening), worsening intensity despite stable or increased doses, and anatomic spread from legs to arms or trunk 1, 5
• Case reports document patients developing severe augmentation during long-term ropinirole therapy, requiring complex transitions to alternative medications 6
• Increasing the ropinirole dose when symptoms worsen paradoxically exacerbates augmentation over time, creating a vicious cycle 1, 5

Prevalence in Current Practice

• While precise epidemiologic data on current ropinirole use patterns are not available, the 2025 AASM guideline shift represents a fundamental change in standard of care 1
• Patients who started ropinirole years ago under older guidelines may still be maintained on it, but new initiations should be rare given current evidence 1
• The scenario described—stable 4 mg daily dosing for years without apparent augmentation—may represent either: (1) a patient who has not yet developed augmentation, (2) unrecognized augmentation, or (3) a rare individual who tolerates long-term dopaminergic therapy 1

Current Evidence-Based Approach

First-Line Therapy (Strong Recommendation)

• Alpha-2-delta ligands (gabapentin, gabapentin enacarbil, pregabalin) are now strongly recommended as first-line treatment with moderate certainty of evidence 1
• These agents avoid the augmentation phenomenon entirely and provide sustained symptom control without paradoxical worsening 1
• Gabapentin dosing: start 300 mg three times daily, titrate by 300 mg/day every 3–7 days to a maintenance dose of 1800–2400 mg/day divided three times daily 1

Iron Assessment (Essential First Step)

• Check morning fasting serum ferritin and transferrin saturation after withholding iron supplements for ≥24 hours 1
• Supplement if ferritin ≤75 ng/mL or transferrin saturation <20%—thresholds higher than general population guidelines because brain iron deficiency plays a key role in RLS pathophysiology 1
• IV ferric carboxymaltose (750–1000 mg) is strongly recommended for rapid correction when oral iron fails or is not tolerated 1

Transitioning Off Ropinirole

• For patients currently on ropinirole who develop augmentation or wish to transition to guideline-concordant therapy 1, 5:
  1. Optimize iron status first (ferritin target >75 ng/mL) 1, 5
  2. Start gabapentin or pregabalin at therapeutic doses before tapering ropinirole 5
  3. Taper ropinirole very slowly (reduce by 0.25 mg every 1–2 weeks) once the alpha-2-delta ligand reaches therapeutic effect 5
  4. Anticipate temporary symptom worsening during the transition; short-acting opioids may be used as bridge therapy in severe cases 1, 5

Refractory Cases

• Extended-release oxycodone (5–10 mg at bedtime) or low-dose methadone/buprenorphine receive conditional recommendations for moderate to severe refractory RLS, particularly when treating dopamine agonist-related augmentation 1
• Long-term observational data show relatively low abuse risk and only modest dose escalation over 2–10 years in appropriately screened patients 1
• Screen for untreated obstructive sleep apnea before initiating opioids due to respiratory depression risk 1

Critical Pitfalls to Avoid

• Do not assume that stable long-term ropinirole use without obvious augmentation means the patient should continue indefinitely—current guidelines recommend proactive transition to first-line agents 1
• Do not increase ropinirole dose if symptoms worsen; this likely represents augmentation and will create a worsening cycle 1, 5
• Do not switch from ropinirole to another dopamine agonist (pramipexole, rotigotine); they carry identical augmentation risk 1
• Do not use levodopa as an alternative; it has even higher augmentation rates than ropinirole 1, 3

Bottom Line

While a 62-year-old woman on ropinirole 4 mg daily for years may have been following standard care when treatment was initiated, this scenario is increasingly uncommon and represents outdated practice by 2025 standards 1. The 2025 AASM guidelines—the highest-quality, most recent evidence—explicitly recommend against standard ropinirole use due to augmentation risk and prioritize alpha-2-delta ligands as first-line therapy 1. Clinicians encountering such patients should proactively discuss transitioning to guideline-concordant treatment, beginning with iron optimization and initiation of gabapentin or pregabalin before slowly tapering the dopamine agonist 1, 5.