pramipexole

Adjunctive therapy

Brands: Mirapex

Last reviewed 2025-12-30

Reviewed by PsychMed Editorial Team.

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Quick answers

What is pramipexole?
Pramipexole (brand Mirapex) is a non-ergoline dopamine agonist indicated for Parkinson’s disease and moderate-to-severe primary RLS (label).
What is Mirapex?
Mirapex is a brand name for pramipexole.
What is Mirapex (pramipexole) used for?
Label indications include: Parkinson’s disease (PD) and moderate-to-severe primary restless legs syndrome (RLS) (label).
What drug class is Mirapex (pramipexole)?
Non-ergoline dopamine agonist (D2/D3-preferring) indicated for Parkinson’s disease and moderate-to-severe primary restless legs syndrome; largely renally eliminated as unchanged drug with clinically important somnolence, impulse- control, hallucination/psychosis, and RLS augmentation considerations.
What strengths does Mirapex (pramipexole) come in?
Tablets: 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 1.5 mg (label).

Snapshot

Class: Adjunctive therapy
Common US brands: Mirapex
Therapeutic drug monitoring not routinely recommended.
Last reviewed: 2025-12-30

Label indications

Parkinson’s disease (PD) and moderate-to-severe primary restless legs syndrome (RLS) (label).

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Clinical Highlights

Pramipexole (brand Mirapex) is a non-ergoline dopamine agonist indicated for Parkinson’s disease and moderate-to-severe primary RLS (label). In RLS, dopamine agonists can be effective but require long-term risk management. A core concern is augmentation (RLS symptoms starting earlier in the day or intensifying after initial benefit), which influences drug choice and follow-up plans (guideline/clinical).

Clinically important adverse effects include somnolence and “sleep attacks,” orthostatic hypotension, hallucinations/psychosis, and impulse-control symptoms; careful monitoring is especially important in serious mental illness (label/clinical).
Pramipexole is largely renally eliminated as unchanged drug, so dosing and tolerability are tied to kidney function (label).
The compare view, pramipexole evidence feed, and print page support side-by-side review of RLS options and monitoring topics.

Dosing & Formulations

Tablets: 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 1.5 mg (label). RLS: start 0.125 mg once daily 2 to 3 hours before bedtime; dose may be increased every 4 to 7 days based on response and tolerability (label).

For RLS, there is no evidence that 0.75 mg provides additional benefit beyond 0.5 mg; dose escalation past typical ranges increases adverse effect risk without clear gain (label).
Renal impairment requires dose adjustment; dose selection is based on creatinine clearance (label).

Monitoring & Risks

Somnolence and sudden sleep onset can occur; next-day impairment and safety-sensitive activities (driving, operating machinery) are core counseling and follow-up topics (label). Neuropsychiatric effects (hallucinations, confusion, impulsivity) can occur and are more likely in older adults and in those with baseline psychiatric vulnerability (label/clinical).

Orthostatic hypotension can occur, especially during titration; blood pressure and dizziness/falls risk are common monitoring targets (label/clinical).
In RLS, monitoring includes whether symptoms are shifting earlier in the day or increasing in intensity (augmentation) and whether dose escalation is being driven by worsening rather than inadequate initial control (guideline/clinical).

Drug Interactions

Pramipexole has negligible CYP metabolism, so CYP-based interactions are limited; interactions more often involve additive sedation or renal tubular secretion effects (label/clinical). Cimetidine and other inhibitors of renal tubular secretion can increase exposure and half-life; monitoring for increased adverse effects is commonly considered when such drugs are started or stopped (label).

Alcohol and other CNS depressants can increase sedation and impairment (label/clinical).

Practice Notes

For RLS, contributors such as iron deficiency, untreated sleep apnea, and medication triggers are often addressed in parallel with medication choice (guideline/clinical). The AASM guideline and updated algorithms increasingly emphasize balancing short-term symptom control against augmentation and other long-term adverse effects when selecting dopamine agonists (guideline).

In serious mental illness, dopamine agonists can complicate psychosis or mood instability; close monitoring for behavioral changes is a key practical safeguard (label/clinical).

References

Pramipexole dihydrochloride tablets prescribing information — DailyMed (2025)
Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine clinical practice guideline — Journal of Clinical Sleep Medicine (2025)
The Management of Restless Legs Syndrome: An Updated Algorithm — Mayo Clinic Proceedings (2021)
Randomized Trial OF Pramipexole FOR Patients With Restless Legs Syndrome (rls) AND RLS Related Impairment OF Mood — Sleep Medicine (2011)