What is the recommended single night dose of Ropinirole (ropinirole) for restless leg syndrome?

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Ropinirole Dosing for Restless Legs Syndrome

For restless legs syndrome, start ropinirole at 0.25 mg once daily taken 1-3 hours before bedtime, and titrate up to a maximum single nighttime dose of 4 mg daily based on symptom response. 1

FDA-Approved Dosing Schedule

The FDA label provides a specific titration protocol for RLS 1:

  • Days 1-2: 0.25 mg once daily
  • Days 3-7: 0.5 mg once daily
  • Week 2: 1 mg once daily
  • Week 3: 1.5 mg once daily
  • Week 4: 2 mg once daily
  • Week 5: 2.5 mg once daily
  • Week 6: 3 mg once daily
  • Week 7: 4 mg once daily (maximum dose)

All doses should be taken 1-3 hours before bedtime as a single nighttime dose. 1 Doses greater than 4 mg daily have not been established as safe or effective for RLS. 1

Critical Guideline Considerations Before Prescribing

The American Academy of Sleep Medicine now suggests against the standard use of ropinirole for RLS due to augmentation risk (conditional recommendation, moderate certainty of evidence). 2 Augmentation is characterized by earlier onset of symptoms during the day, increased symptom intensity, and spread of symptoms to other body parts. 2

Preferred First-Line Treatment

Alpha-2-delta ligands (gabapentin, gabapentin enacarbil, or pregabalin) are now strongly recommended as first-line therapy over dopamine agonists like ropinirole due to lower augmentation risk. 2, 3

When Ropinirole May Be Considered

Ropinirole may only be appropriate for patients who 2:

  • Prioritize short-term symptom relief over long-term adverse effects
  • Are explicitly informed of augmentation risk
  • Have a monitoring and switching plan if augmentation develops

Special Population Dosing

End-stage renal disease on hemodialysis: Start at 0.25 mg once daily with a maximum of 3 mg/day (not 4 mg). 1 No supplemental doses after dialysis are required. 1

Moderate renal impairment (CrCl 30-50 mL/min): No dose adjustment necessary. 1

Key Monitoring and Safety Points

Watch for these side effects, particularly in older patients 2:

  • Orthostatic hypotension and dizziness
  • Headache
  • Nausea

Monitor closely for augmentation signs, which require dose reduction or switching to alpha-2-delta ligands. 2, 4

Discontinuation Protocol

When stopping ropinirole, gradual reduction is recommended rather than abrupt cessation. 1 Consider transitioning to gabapentin or pregabalin if augmentation develops. 4

References

Guideline

Ropinirole Treatment for Restless Legs Syndrome

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Management of Restless Legs Syndrome (RLS)

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Restless Legs Syndrome Treatment Guidelines

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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