Maximum Recommended Dose of Ropinirole
The maximum recommended dose of ropinirole is 24 mg/day (8 mg three times daily) for Parkinson's disease and 4 mg/day (taken once daily) for Restless Legs Syndrome (RLS). 1
Dosing for Parkinson's Disease
Ropinirole dosing for Parkinson's disease follows a careful titration schedule:
- Initial dose: 0.25 mg three times daily (0.75 mg total daily dose)
- Titration schedule:
- Week 1: 0.25 mg three times daily (0.75 mg/day)
- Week 2: 0.5 mg three times daily (1.5 mg/day)
- Week 3: 0.75 mg three times daily (2.25 mg/day)
- Week 4: 1 mg three times daily (3 mg/day)
- After Week 4: Increase by 1.5 mg/day weekly up to 9 mg/day
- Then: Increase by up to 3 mg/day weekly up to maximum 24 mg/day 1
The FDA label clearly states that doses greater than 24 mg/day have not been tested in clinical trials for Parkinson's disease, establishing this as the maximum recommended dose. Clinical evidence suggests that while many patients respond at lower doses, some patients with early Parkinson's disease may benefit from continued dose titration, potentially requiring the maximum recommended dose of 24 mg/day 2.
Dosing for Restless Legs Syndrome
For RLS, the dosing is significantly lower:
- Initial dose: 0.25 mg once daily, 1-3 hours before bedtime
- Titration schedule:
- 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 1
The FDA label explicitly states that for RLS, "the safety and effectiveness of doses greater than 4 mg once daily have not been established," making 4 mg/day the maximum recommended dose for this indication 1. This is consistent with clinical research showing that the mean effective dose for RLS is typically much lower than what is needed for Parkinson's disease, with studies reporting mean doses around 1.4-1.9 mg/day 3, 4.
Special Considerations for Renal Impairment
- Moderate renal impairment (CrCl 30-50 mL/min): No dose adjustment needed
- End-stage renal disease on hemodialysis:
- For Parkinson's: Start with 0.25 mg three times daily; maximum 18 mg/day
- For RLS: Start with 0.25 mg once daily; maximum 3 mg/day 1
Important Clinical Considerations
- Ropinirole should be discontinued gradually over a 7-day period in Parkinson's disease patients to prevent withdrawal symptoms 1
- For RLS, gradual dose reduction is also recommended when discontinuing therapy 1
- The American Academy of Sleep Medicine recommends dopamine agonists like ropinirole for short-term symptom relief in RLS/PLMD but cautions about the risk of augmentation (paradoxical worsening of symptoms) with long-term use 5
- Alpha-2-delta ligands (pregabalin, gabapentin) are now strongly recommended as first-line pharmacologic therapy for periodic limb movements in sleep due to their favorable long-term safety profile compared to dopaminergic agents 5