Stiripentol and Somnolence: is the FAERS signal real?
Stiripentol ↔ Somnolence
Stiripentol is an antiepileptic used with clobazam in Dravet syndrome; somnolence and sedation are its most common effects (230 co-reports, PRR 11.2), amplified because stiripentol inhibits CYP enzymes and raises clobazam and other antiepileptic levels. The label advises caution with CNS depressants, and the sedation is managed by dose adjustment.
Regulatory basis: stiripentol (Diacomit) prescribing information — somnolence; CYP inhibition raising co-medication levels.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Somnolence follows dosing |
| Strength | met | PRR 11.2, large |
| Consistency | met | Consistent across trials |
| Specificity | partial | Shared with other CNS-active antiepileptics |
| Biological gradient | met | Dose-related |
| Plausibility | met | GABA-A potentiation plus CYP inhibition |
| Coherence | met | Fits the pharmacology |
| Experiment | met | Trials recorded sedation |
| Analogy | met | Analogous to clobazam 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 — A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥ 2 Years Old and Young Adults With Dravet Syndrome (NCT02926898)
| Adverse event | Cohort 2: ZX008 0.5 mg/kg/Day (n=43) · Cohort 2: Matching Placebo (n=44) | |
|---|---|---|
| Somnolence | 3/43 | 3/44 |
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 →