Fezolinetant → Insomnia — Audit-grade candidate (scan)

Drug: fezolinetant · AE: Insomnia

Discovered via single-drug scan of fezolinetant. PRR = 3.10 (95% CI 2.53–3.81), n = 87 cases. Pre-reg locked at submission time.

Disproportionality

• PRR: 3.1017550686610833 (95% CI 2.53–3.81)
• Yates χ²: 123.56128667821382
• Cases (case-drug + AE): n = 87
• Verdict: PASSES_ALL_GATES — PRR=3.10 (95% CI 2.53–3.81), n=87 cases; flagged for clinical expert review, NOT for external escalation without manual verification

Top reactions in cohort

Source: openFDA FAERS, Caliper Engine v0. Pre-registration sha1 locked at submission time; ledger entry signed with platform Ed25519 key.