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Ropinirole

AEMPS

Non-ergot dopamine D2/D3 receptor agonist

ATC code: N04BC04

Brand names: Ropinirol Cinfa, Requip, Requip Modutab

Updated · Methodology

Indications

A

Parkinson's disease

First line

First-line in Parkinson's disease in patients under 65 to delay levodopa or in combination with levodopa for motor fluctuations. Starting dose immediate-release 0.25 mg three times daily or extended-release 2 mg once daily. Efficacy comparable to pramipexole per REAL-PET and CALM-PD. Also raises impulse-control disorder risk ( 2012, 2014 warning).

Sources

  1. AEMPS: Ficha técnica de Ropinirol (2024)
  2. New England Journal of Medicine: A Five-Year Study of the Incidence of Dyskinesia in Patients with Early Parkinson's Disease Who Were Treated with Ropinirole or Levodopa (2000)
  3. Movement Disorders: International Parkinson and movement disorder society evidence‐based medicine review: Update on treatments for the motor symptoms of Parkinson's disease (2018)

ICD-10: G20 · ICD-11: 8A00.0

B

Restless legs syndrome

Second line

Second-line for moderate-to-severe restless legs syndrome per 2024. First-line is iron supplementation in ferritin deficiency and α2δ ligands (gabapentin, pregabalin). Ropinirole 0.25–4 mg 2–3 hours before bed. Long-term use is linked to augmentation – switch the drug when augmentation appears.

Sources

  1. AEMPS: Ficha técnica de Ropinirol (2024)
  2. Journal of Clinical Sleep Medicine: Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine clinical practice guideline (2025)
  3. Sleep Med: Dopamine agonists in restless leg syndrome treatment and their effects on sleep parameters: A systematic review and meta-analysis. (2024)

ICD-10: G25.81 · ICD-11: 7A80

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Insomnia and sleep disorders

Not recommended

Ropinirole is a dopamine receptor agonist. It is prescribed for Parkinson's disease and for moderate-to-severe restless legs syndrome (RLS) ( 2018 guidelines and AEMPS Ficha Técnica). For mild nighttime leg symptoms that do not meet objective RLS criteria, ropinirole is not used. The drug has serious risks: pathological gambling, hypersexuality, compulsive behaviors ( warning, 2014), sudden sleep attacks with risk of falling asleep at the wheel, and augmentation on long-term RLS treatment (paradoxical worsening of symptoms). If ropinirole was prescribed for suspected RLS, check serum ferritin (iron deficiency is a common reversible cause) and reassess the prescription with the clinician. If RLS has not been confirmed by IRLSSG criteria, consider seeking a second opinion.

Sources

  1. AEMPS: Ficha técnica de Ropinirol (2024)
  2. ESRS: European guideline for the diagnosis and treatment of insomnia (2023)

ICD-10: G47.0 · ICD-11: 7A00

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

A selective D2-family dopamine receptor agonist with preferential D3 activity. Compared with pramipexole, longer 6-hour half-life; extended-release allows once-daily dosing. No fibrotic complication risk unlike ergot agonists. CYP1A2-metabolized – significant interactions with smoking (CYP1A2 induction) and ciprofloxacin (inhibition).

Safety

Contraindications

  • Ropinirole hypersensitivity
  • Severe renal impairment without dialysis
  • Severe hepatic impairment
  • Pregnancy and lactation
  • Age under 18

Serious adverse effects

  • Impulse-control disorders (FDA 2012 and EMA 2014 warning)
  • Augmentation in restless legs syndrome
  • Sudden sleep attacks without warning while driving
  • Psychotic disorders, hallucinations
  • Heart failure (long-term high doses)

Common adverse effects

  • Nausea
  • Drowsiness and sudden sleep attacks
  • Dizziness
  • Orthostatic hypotension
  • Dyskinesias (in Parkinson's with concomitant levodopa)
  • Constipation
  • Fatigue

Pregnancy: can you take Ropinirole?

Limited data.

Breastfeeding: can you take Ropinirole?

Suppresses lactation via prolactin inhibition.

Calculate RIDFull profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Common myths

Myth: «dopamine agonists are safe without serious psychological effects.» Fact: 2012 and 2014 issued a warning about impulse-control disorders on dopamine agonists (pramipexole, ropinirole, rotigotine): pathological gambling (2–8-fold raised risk), hypersexuality, binge eating, compulsive shopping. Frequency 13–17% in Parkinson's. Reversible after discontinuation but often unnoticed. Before start and every 3 months, ask the patient and family. Smoking significantly lowers ropinirole levels – on smoking cessation, dose adjustment is needed.
Label mentions14 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • Majorantipsicóticosclass named in the label
    «Los neurolépticos y otros antagonistas dopaminérgicos con actividad a nivel central, como sulpirida o metoclopramida, pueden disminuir la eficacia de ropinirol y, por tanto, debe evitarse el uso…»

    AEMPS, section 4.5 · Open on CIMA

  • MajorMetoclopramide
    «Los neurolépticos y otros antagonistas dopaminérgicos con actividad a nivel central, como sulpirida o metoclopramida, pueden disminuir la eficacia de ropinirol y, por tanto, debe evitarse el uso…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateantipsychoticsclass named in the label
    «DRUG INTERACTIONS: Inhibitors or inducers of CYP1A2: May alter the clearance of ropinirole; dose adjustment of ropinirole may be required. (7.1, 12.3) Hormone replacement therapy (HRT): Starting or…»

    FDA, section 7 · Open on DailyMed

  • ModerateCiprofloxacin
    «Ropinirol se metaboliza principalmente por la isoenzima CYP1A2 del citocromo P450. Un estudio farmacocinético (con una dosis de ropinirol comprimidos recubiertos con película de liberación inmediata…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateCiprofloxacin
    «DRUG INTERACTIONS: Inhibitors or inducers of CYP1A2: May alter the clearance of ropinirole; dose adjustment of ropinirole may be required. (7.1, 12.3) Hormone replacement therapy (HRT): Starting or…»

    FDA, section 7 · Open on DailyMed

  • ModerateFluvoxamine
    «Ropinirol se metaboliza principalmente por la isoenzima CYP1A2 del citocromo P450. Un estudio farmacocinético (con una dosis de ropinirol comprimidos recubiertos con película de liberación inmediata…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateMetoclopramide
    «DRUG INTERACTIONS: Inhibitors or inducers of CYP1A2: May alter the clearance of ropinirole; dose adjustment of ropinirole may be required. (7.1, 12.3) Hormone replacement therapy (HRT): Starting or…»

    FDA, section 7 · Open on DailyMed

  • Domperidone
    «No hay ninguna interacción farmacocinética entre ropinirol y levodopa o domperidona que obligue al ajuste posológico de estos fármacos.»

    AEMPS, section 4.5 · Open on CIMA

  • Theophylline
    «Un estudio de interacción farmacocinética en pacientes con la enfermedad de Parkinson entre ropinirol (a una dosis de 2 mg, tres veces al día) y teofilina, como fármaco representativo de los…»

    AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

  • MajorAmisulpride
    «Levodopa: antagonismo recíproco de efectos entre levodopa y neurolépticos. Amisulprida puede oponerse al efecto de los agonistas dopaminérgicos p. ej., bromocriptina, ropinirol.»

    AEMPS, section 4.5 · Open on CIMA

  • MajorCiprofloxacin
    «DRUG INTERACTIONS: Ropinirole Use with caution Monitoring for ropinirole-related adverse reactions and appropriate dose adjustment of ropinirole is recommended during and shortly after…»

    FDA, section 7 · Open on DailyMed

  • ModerateFluvoxamine
    «Medicamentos con estrecho margen terapéutico: Dado que las concentraciones plasmáticas de ropinirol se pueden ver aumentadas en el tratamiento combinado con fluvoxamina, provocando así un riesgo de…»

    AEMPS, section 4.5 · Open on CIMA

  • Ciprofloxacin
    «Ropinirol: En un ensayo clínico se demostró que el uso concomitante de ropinirol con ciprofloxacino, un inhibidor moderado de la isoenzima CYP450 1A2, produce un aumento de la C máx y de la AUC del…»

    AEMPS, section 4.5 · Open on CIMA

  • Nicotine
    «Fumar (no la nicotina) se asocia con un aumento en la actividad de la enzima CYP1A2. Después de dejar de fumar, puede ocurrir que se reduzca el aclaramiento de sustratos de esta enzima. Esto puede…»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Ropinirole used for?

Ropinirole is evaluated for the following indications with varying evidence strength: Parkinson's disease (evidence tier A), Restless legs syndrome (evidence tier B), Insomnia and sleep disorders (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Ropinirole?

Common side effects of Ropinirole (≥ 1 in 100): Nausea, Drowsiness and sudden sleep attacks, Dizziness, Orthostatic hypotension, Dyskinesias (in Parkinson's with concomitant levodopa), Constipation. See the Safety section for uncommon and serious reactions.

Is Ropinirole safe during pregnancy?

Limited data.

Is Ropinirole compatible with breastfeeding?

Suppresses lactation via prolactin inhibition.

Who should not take Ropinirole?

Ropinirole is contraindicated in: Ropinirole hypersensitivity; Severe renal impairment without dialysis; Severe hepatic impairment; Pregnancy and lactation; Age under 18. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Bromocriptine, Cabergoline, Levodopa + Carbidopa + Entacapone, Pramipexole, Rasagiline, Selegiline