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Causality: well established
Causality assessment · Causality: well established
Pramipexole and Somnolence: is the FAERS signal real?
A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.
Pramipexole ↔ Somnolence
n=557 co-reports · PRR 3.8 · ROR 3.9
Pramipexole commonly causes somnolence and can produce sudden-onset sleep attacks, a hazard for driving; 557 co-reports give PRR 3.8. The label warns of somnolence and advises caution with driving.
Regulatory basis: pramipexole prescribing information — somnolence and sudden sleep onset; driving caution.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Days to weeks |
| Strength | met | PRR 3.8 with 557 co-reports |
| Consistency | met | Reproduced across cohorts |
| Specificity | not established | Somnolence is common |
| Biological gradient | met | Dose-related |
| Plausibility | met | Known dopaminergic mechanism |
| Coherence | met | Fits pramipexole's CNS effects |
| Experiment | n/a | Often coded in trials |
| Analogy | met | Analogous to other dopamine-agonist sedation |
This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.
✓ Trial evidence found — Special Survey on Parkinson's Disease Patients Treated Long-term Use of Pramipexole (NCT00615914)
| Adverse event | Pramipexole (n=1553) |
|---|---|
| Somnolence | 3/1553 |
Post-marketing signal terms appear in this trial's posted adverse-event tables; per-arm counts shown as affected/at-risk. View on ClinicalTrials.gov →