What are the risks of higher doses of Requip (Ropinirole)?

From the Guidelines

Higher doses of Requip (ropinirole) are associated with an increased risk of adverse effects, and their use should be approached with caution, as suggested by the American Academy of Sleep Medicine (AASM) in their 2025 clinical practice guideline 1. The AASM suggests against the standard use of ropinirole for the treatment of restless legs syndrome (RLS) due to the potential for adverse effects, particularly with long-term use and higher doses 1. Some key points to consider when using Requip include:

• Starting with a low dose, typically 0.25 mg three times daily, and gradually titrating upward based on response and tolerability
• Being aware of the potential for excessive daytime sleepiness, sudden sleep episodes, dizziness, nausea, hallucinations, compulsive behaviors, and orthostatic hypotension, especially at higher doses
• Elderly patients and those with kidney impairment may require lower doses due to increased susceptibility to adverse effects
• Reducing the dose may help manage troublesome side effects while maintaining some therapeutic benefit
• The maximum recommended daily dose is 24 mg, but many patients find optimal benefit at lower doses It is essential to consult with a healthcare provider before making any changes to Requip dosage, as they can help determine the best course of treatment and minimize the risk of adverse effects 1.

From the FDA Drug Label

Hypotension and/or orthostatic symptoms may occur more frequently during initial therapy or with an increase in dose at any time (cases have been seen after weeks of treatment). In patients with Parkinson’s disease, the elderly are at greater risk than younger patients This risk is greater in patients who are taking ropinirole tablets with L-dopa or taking higher doses of ropinirole tablets and may also be further increased in patients taking any other drugs that increase dopaminergic tone. Although the clinical trials were not designed to systematically monitor blood pressure, there were individual reported cases of orthostatic hypotension in early Parkinson’s disease (without L-dopa) in patients treated with ropinirole. Most of these cases occurred more than 4 weeks after initiation of therapy with ropinirole and were usually associated with a recent increase in dose Syncope, sometimes associated with bradycardia, was observed in association with treatment with ropinirole in both patients with Parkinson’s disease and patients with RLS

The risks of higher doses of Requip (Ropinirole) include:

• Hypotension and/or orthostatic symptoms: may occur more frequently with an increase in dose
• Syncope: may be associated with bradycardia
• Hallucinations/Psychotic-Like Behavior: risk is greater in patients taking higher doses of ropinirole tablets, especially in the elderly and those taking L-dopa or other drugs that increase dopaminergic tone 2, 3, 4

From the Research

Risks of Higher Doses of Requip (Ropinirole)

• The provided studies do not directly address the risks of higher doses of Requip (Ropinirole) 5, 6, 7, 8, 9.
• However, study 7 suggests that ropinirole may play a role in inducing or exacerbating psychosis and its associated features, although a number of confounding variables prevent the determination of a clear association.
• Study 9 found that 75% of patients who experienced a therapeutic response to ropinirole did so at a dose of ≤ 7.5 mg/day, and that continued dose titration may be beneficial for most patients with early Parkinson's disease.
• Study 6 discusses the optimal dose of risperidone, a different medication, and its potential risks and benefits, but does not provide information on ropinirole.
• Studies 5 and 8 discuss the use of ropinirole for the treatment of restless legs syndrome, but do not address the risks of higher doses.
• Study 9 mentions that the maximum recommended dose of ropinirole is 24 mg/day, but does not provide information on the risks associated with higher doses.