Ropinirole hydrochloride for Parkinson’s disease

What is ropinirole for Parkinson’s disease?

Ropinirole hydrochloride is an approved oral therapy used alone or with other medications to manage the symptoms of Parkinson’s disease.

In Parkinson’s, the nerve cells that produce dopamine, a chemical messenger, gradually die off, leading to a range of motor and nonmotor symptoms.

Ropinirole is a dopamine agonist, meaning it mimics some of dopamine’s effects by binding to the same receptors as dopamine. This helps compensate for low dopamine levels in the brain and improve motor function.

The therapy may be prescribed alone to manage symptoms such as tremors or stiffness. It may also be combined with levodopa to reduce off episodes, periods when levodopa’s effects wear off before the next dose.

Ropinirole is available in both immediate-release and extended-release formulations. The immediate-release version is also approved to treat moderate-to-severe primary restless legs syndrome. GlaxoSmithKline originally developed and sold the medication under the brand names Requip and Requip XL, but only generic ropinirole is now available.

Therapy snapshot

Brand name	Available as a generic medication only
Chemical name	Ropinirole hydrochloride
Usage	Used to ease symptoms of Parkinson’s disease, alone or combined with other therapies
Administration	Immediate-release and extended-release oral tablets

Who with Parkinson’s disease can take ropinirole?

In the U.S., ropinirole is approved to treat Parkinson’s disease. It holds similar approvals in other regions, including the European Union and Canada.

Ropinirole’s prescribing information notes that the therapy is contraindicated, meaning it should not be used by people with a history of allergic or hypersensitivity reactions to the medication or any of its ingredients.

It is also not usually recommended for people with major psychotic disorders because dopamine agonists can worsen their symptoms.

How is ropinirole administered in Parkinson’s disease?

Ropinirole is available as oral tablets to be taken with or without food. The medication comes in two different formulations: 

• immediate-release: taken three times daily
• extended-release: taken once daily; the tablets should be swallowed whole and not chewed, crushed, or divided

Doctors typically recommend starting at a low ropinirole dosage and gradually increasing it as needed to control symptoms. The maximum daily dose with either formulation is 24 mg.

Patients can switch from the immediate-release formulation to extended-release ropinirole under the supervision of a healthcare provider.

Individuals with end-stage kidney disease who are receiving regular dialysis should be monitored during dose adjustment and should not exceed a maximum daily dose of 18 mg.

Ropinirole in Parkinson’s disease clinical trials

Three clinical trials from the late 1990s supported the approval of immediate-release ropinirole:

• Two of these studies tested ropinirole against a placebo in people with early Parkinson’s who were not receiving levodopa. Data from both studies generally showed that ropinirole was associated with a significant reduction in motor symptom severity compared with a placebo.
• Another study tested add-on ropinirole against a placebo in people with advanced Parkinson’s who were taking levodopa but did not have adequate symptom control. People taking ropinirole were significantly more likely than those taking a placebo to experience at least a 20% reduction in both daily off time and levodopa dose (35% vs. 13%).

Extended-release ropinirole was supported by four additional clinical trials:

• The EASE-PD Monotherapy trial showed that the extended-release formulation performed as well as the immediate-release formulation in easing motor symptoms in people with early Parkinson’s and allowed for faster dose adjustments.
• A Phase 4 trial called TANDEM-662 (NCT01485172) found in a prespecified additional analysis that daily extended-release ropinirole at 12 mg led to significant reductions in motor symptom severity relative to a placebo in early-stage Parkinson’s, with no clear added benefit from a higher dose.
• A study in people with advanced Parkinson’s who were experiencing off periods while taking levodopa showed that ropinirole significantly decreased daily off time by 1.8 hours compared with a placebo.
• The Phase 4 TANDEM-569 trial (NCT01494532) showed that all tested doses of ropinirole reduced motor symptom severity relative to a placebo in people with advanced Parkinson’s who were taking levodopa. An 8 mg daily dose also significantly reduced off time while increasing on time without troublesome unwanted movements (dyskinesia, a common side effect of levodopa).

Ropinirole side effects

The most common side effects of immediate-release ropinirole in people with early Parkinson’s disease include:

• nausea
• vomiting
• sleepiness
• dizziness
• fainting
• fatigue, tiredness, and weakness
• viral infection
• leg swelling
• indigestion

The most common side effects of immediate-release ropinirole in people with advanced Parkinson’s disease who are also receiving levodopa include:

• dyskinesia
• sleepiness
• nausea
• dizziness
• confusion
• hallucinations, or seeing or hearing things that are not real
• sweating
• headache

The most common side effects of extended-release ropinirole in people with early Parkinson’s disease include:

• nausea
• sleepiness or suddenly falling asleep
• high blood pressure
• headache
• abdominal pain or discomfort
• dizziness
• constipation

The most common side effects of extended-release ropinirole in people with advanced Parkinson’s who are also receiving levodopa include:

• nausea
• dyskinesia
• dizziness
• hallucinations

Both formulations carry several warnings for potentially serious side effects:

• excessive sleepiness and suddenly falling asleep 
• fainting, especially around the time of a dose increase
• low blood pressure, especially when standing up (orthostatic hypotension)
• hallucinations, especially in people older than 65, and psychotic-like behaviors
• problems with impulse control or increased compulsive behaviors
• high blood pressure and heart rate changes with the extended-release formulation

Patients should be carefully monitored for these side effects, especially around the time of a dose change. If they occur, a doctor may recommend reducing the dose or discontinuing treatment. Ropinirole should not be suddenly discontinued because abrupt withdrawal can cause symptoms such as high fever and confusion. The medication should be gradually tapered under medical supervision.

Ropinirole may interact with other medications, including certain antipsychotics, hormone replacement therapies, and dopamine blockers. Because of these potential ropinirole drug interactions, individuals should tell their care team about all other medications they are using.

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