From the Guidelines
Mirapex (pramipexole) should be started at a dose of 0.125 mg administered orally at bedtime and can be increased, slowly, to 2.0 mg nightly for the treatment of isolated REM sleep behavior disorder (RBD). The dosing of Mirapex (pramipexole) is based on the latest clinical practice guideline from the American Academy of Sleep Medicine, which suggests the use of pramipexole for the treatment of isolated RBD in adults 1.
Key Considerations
- The mechanism of efficacy of pramipexole in RBD is uncertain, but it may help reduce ancillary motor activity or treat underlying sleep-fragmenting conditions such as periodic limb movement disorder 1.
- The starting dose of 0.125 mg at bedtime can be increased slowly to 2.0 mg nightly, with the goal of minimizing side effects and maximizing efficacy 1.
- Common side effects of pramipexole include next-day hangover, gastrointestinal symptoms, and negative impulsive behavior, but the benefits of treatment are thought to outweigh the risks 1.
Clinical Context
- Pramipexole is typically used to treat motor symptoms of Parkinson's disease, restless legs syndrome, and periodic limb movement disorder, but its use in isolated RBD is supported by observational studies 1.
- The American Academy of Sleep Medicine suggests the use of pramipexole for the treatment of isolated RBD in adults, based on improvements in the frequency and/or intensity of dream enactment episodes 1.
- The overall certainty of evidence for the use of pramipexole in isolated RBD is very low due to imprecision and the risk of bias associated with observational studies, but the balance between the desirable and undesirable effects is thought to be in favor of pramipexole 1.
From the FDA Drug Label
DOSAGE AND ADMINISTRATION Parkinson's Disease In all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients The dosage should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth. Dosing in Patients With Normal Renal Function Initial Treatment Dosages should be increased gradually from a starting dose of 0. 375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table: Table 3: Ascending Dosage Schedule of Pramipexole Dihydrochloride Tablets for Parkinson's Disease Week Dosage (mg)Total Daily Dose (mg) 1 0.125 tid0.375 20.25 tid0.75 30.5 tid1.50 40. 75 tid2.25 51 tid3 61.25 tid3.75 71.5 tid4.50 Maintenance Treatment Pramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
The dosing for Mirapex (Pramipexole) is as follows:
- Initial Treatment: 0.375 mg/day given in three divided doses, increased gradually every 5 to 7 days.
- Maintenance Treatment: 1.5 to 4.5 mg/day administered in equally divided doses three times per day.
- Dosage Adjustment: The dosage should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects. 2
From the Research
Dosing for Mirapex (Pramipexole)
- The dosing for Mirapex (Pramipexole) varies depending on the condition being treated:
- For restless legs syndrome, a single oral dose of pramipexole of between 0.125 and 0.750 mg, taken 2 - 3 h before bedtime, is usually able to control sensory symptoms and motor signs 3.
- In another study, the optimal dosage for restless legs syndrome was 0.25 mg for one patient, 0.5 mg for five patients, and 0.75 mg for one patient 4.
- For Parkinson's disease, the dosage should be increased gradually from a starting dose of 0.375 mg/day up to a maximum of 4.5 mg/day in equally divided doses taken three times per day with pramipexole immediate-release or equivalent daily dosages once-daily with pramipexole extended-release 5.
- In other studies, mirapex was administered in a mean dose of 3.5 +/- 1.1 mg/day for Parkinson's disease 6, 7.