Dopamine Agonist (D2/D3 Receptor) Pregnancy: The effect on pregnancy and lactation has not been investigated in humans. Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses. Should not be used during pregnancy unless clearly necessary, i.e. if the potential benefit justifies the potential risk to the foetus. Breast-feeding: pramipexole inhibits secretion of prolactin in humans so inhibition of lactation is expected; excretion into human breast milk has not been studied and, in the absence of human data, pramipexole should not be used during breast-feeding - if its use is unavoidable, breast-feeding should be discontinued.

Pramipexole (Restless Legs Syndrome — Elderly)

Brand names: Mirapexin, Sifrol

Pramipexole is a dopamine agonist used for Parkinson's disease and for moderate-to-severe restless legs syndrome. It is renally excreted.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Restless Legs Syndrome: recommended starting dose 0.088 mg of base (0.125 mg of salt) taken once daily 2-3 hours before bedtime; for patients requiring additional symptomatic relief the dose may be increased every 4-7 days to a maximum of 0.54 mg of base (0.75 mg of salt) per day

Route: Oral - tablets swallowed with water, with or without food

Frequency: Once daily in the evening, 2-3 hours before bedtime

Max: 0.54 mg of base (0.75 mg of salt) per day for Restless Legs Syndrome

DOSES ARE STATED BOTH AS BASE AND AS SALT - do not mix the two scales. RLS titration schedule from §4.2 (once daily evening dose, base / salt): step 1, 0.088 mg / 0.125 mg; step 2 (if needed), 0.18 mg / 0.25 mg; step 3 (if needed), 0.35 mg / 0.50 mg; step 4 (if needed), 0.54 mg / 0.75 mg. The lowest effective dose should be used (see §4.4 restless legs augmentation syndrome). The patient's response should be evaluated after 3 months of treatment and the need for treatment continuation reconsidered. If treatment is interrupted for more than a few days it should be re-initiated by dose titration carried out as above. DISCONTINUATION: since the daily dose for RLS will not exceed 0.54 mg of base (0.75 mg of salt), pramipexole can be discontinued without tapering off; in a 26-week placebo-controlled trial, rebound of RLS symptoms was observed in 10% of patients (14 of 135) after abrupt discontinuation, similar across all doses. ELDERLY: the fetched §4.2 contains NO elderly-specific dose or dose adjustment for either indication - none should be inferred; note only that elimination is dependent on renal function (see renalAdjustment) and that renal function commonly declines with age. PAEDIATRIC: not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy. SEPARATE PARKINSON'S DISEASE REGIMEN IN THE SAME SPC, WHICH DOES NOT APPLY TO THIS PAGE: 0.264 mg of base (0.375 mg of salt) per day in three equally divided doses, increased every 5-7 days, up to a maximum of 3.3 mg of base (4.5 mg of salt) per day - roughly six times the RLS maximum, so the two must never be confused. Fetched SPC is MIRAPEXIN 0.088 mg tablets (https://www.medicines.org.uk/emc/product/1553/smpc). The openFDA record in this bundle is a pramipexole EXTENDED-RELEASE tablet labelled for Parkinson's disease only (0.375 mg once daily up to 4.5 mg/day) and was not used for this page.

Dose adjustments

Renal

Restless Legs Syndrome: patients with a creatinine clearance above 20 mL/min require no reduction in daily dose. Use has not been studied in haemodialysis patients or in patients with severe renal impairment. (The Parkinson's disease renal schedule in the same SPC is different and does not apply to this page: creatinine clearance above 50 mL/min, no reduction; 20 to 50 mL/min, initial daily dose given in two divided doses starting at 0.088 mg base / 0.125 mg salt twice a day, maximum 1.57 mg base / 2.25 mg salt daily; less than 20 mL/min, single daily dose starting at 0.088 mg base / 0.125 mg salt, maximum 1.1 mg base / 1.5 mg salt daily.) Hepatic impairment: dose adjustment is not required, as approximately 90% of absorbed active substance is excreted through the kidneys.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

US labelling (FDA)

Reference — US labelling, may differ from UK

Pramipexole dihydrochloride extended-release tablets are taken once daily, with or without food (2.1) Tablets must be swallowed whole and must not be chewed, crushed, or divided (2.1) Starting dose is 0.375 mg given once daily (2.2) Dose may be increased gradually, not more frequently than every 5 to 7 days, first to 0.75 mg per day and then by 0.75 mg increments up to a maximum recommended dose of 4.5 mg per day. Assess therapeutic response and tolerability at a minimal interval of 5 days or longer after each dose increment. (2.2) Patients may be switched overnight from immediate-release pramipexole tablets to extended-release pramipexole tablets at the same daily dose. Dose adjustment may …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2021-08-31. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

Hypersensitivity to the active substance or to any of the excipients

Side effects

Somnolence and sudden onset of sleep; the incidence of somnolence is increased at doses higher than 1.1 mg of base (1.5 mg of salt) per day
Nausea, constipation and vomiting
Dizziness, headache and hypotension (hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast)
Hallucinations, abnormal dreams, insomnia and confusion
Behavioural symptoms of impulse control disorders and compulsions - compulsive shopping, pathological gambling, hypersexuality, binge eating and hyperphagia (uncommon)
Fatigue, peripheral oedema, and dopamine agonist withdrawal syndrome including apathy, anxiety, depression, fatigue, sweating and pain
The reactions above are taken from the Parkinson's disease pooled analysis in §4.8, which is the portion retrieved before the source-fetch limit; the RLS-specific §4.8 table was NOT retrieved - verify RLS frequencies against the full SPC §4.8

Interactions

Dopamine antagonists such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide - may diminish the effectiveness of pramipexole (US label §7.1)
Levodopa - it is recommended that the dose of levodopa is reduced during both dose escalation and maintenance treatment with pramipexole, depending on reactions in individual patients (UK SPC §4.2; stated for Parkinson's disease)
Interactions are taken from the US prescribing information and from §4.2 because the fetched eMC bundle contains no §4.5 section - verify against the full UK SPC §4.5

Clinical monograph

How it works

It directly stimulates dopamine receptors (with relative selectivity for the D2/D3 subfamily), mimicking dopamine in the brain.

Prescribing in practice

Impulse-control disorders (such as pathological gambling, hypersexuality, binge eating and compulsive shopping) and sudden onset of sleep or excessive daytime sleepiness can occur — warn patients and carers and advise caution with driving.
Nausea, postural hypotension and hallucinations are recognised effects, particularly in older people.
Reduce the dose in renal impairment and do not stop abruptly, withdrawing gradually instead.

Monitoring

Ask specifically and repeatedly about impulse-control behaviours and daytime sleepiness; monitor motor response, blood pressure (including postural), mental state and renal function.

Counselling the patient

Tell your prescriber or family if you notice new urges to gamble, shop, eat or engage in sexual behaviour — these can be a side effect.
You may fall asleep suddenly or feel very sleepy in the daytime — do not drive or operate machinery until you know how it affects you.
Do not stop the medicine suddenly, and rise slowly to reduce dizziness.

Evidence & guidelines

Licensed dopamine agonist; guideline-recognised in Parkinson's disease (NICE NG71) and restless legs syndrome.

Reference: MHRA Drug Safety Update 2012 (impulse control disorders); IRLSSG Diagnostic Criteria and Treatment Recommendations 2023; Allen et al. Sleep Medicine Reviews (augmentation); NICE CG35 (Parkinson's disease); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Drugs

Pramipexole · Dopamine Agonist (D2/D3 Receptor)

Pathways