Ambien Safety Profile & Adverse Events

Safety Profile Overview

Sedative-hypnotic for insomnia. FDA required lower doses for women in 2013 due to next-morning impairment. Monitored for complex sleep behaviors.

Generic Name

zolpidem

Brand Names

Ambien, Ambien CR

Therapeutic Class

Non-Benzodiazepine Hypnotic

Manufacturer

Sanofi

What Pharma Signal Tracks for Ambien

Adverse Events (FAERS) — All FDA Adverse Event Reporting System reports mentioning Ambien, including serious outcomes, hospitalizations, and deaths.
FDA Recalls — Class I, II, and III recalls, market withdrawals, and safety alerts related to Ambien products.
Label Changes — Boxed warning additions, new contraindications, dosing modifications, and safety-related labeling supplements.
Risk Score — Composite risk score (0–100) combining adverse event rates, recall history, and label severity with explainable breakdown.
Pharmacovigilance Signals — Proportional Reporting Ratio (PRR) and Reporting Odds Ratio (ROR) analysis detecting disproportionate adverse reactions.
Trend Analysis — Monthly time series with anomaly detection for emerging safety signals.

Data Disclaimer: Pharma Signal aggregates data from the FDA Adverse Event Reporting System (FAERS) and other public regulatory sources. FAERS reports do not establish causation. Report counts may reflect prescription volume rather than relative safety. Always consult healthcare professionals for medical decisions.

Get Ambien Safety Data via API

One API call returns adverse events, risk scores, recalls, and pharmacovigilance signals for Ambien.

curl "https://api.pharma-signal.com/drug/safety/ambien" \
  -H "X-API-Key: your_key"

# Returns risk score, adverse event counts,
# serious/death rates, recalls, and signals

Try the API API Reference

Related Safety Intelligence

Pharma Signal provides comparative analysis across therapeutic classes. Compare Ambien against other Non-Benzodiazepine Hypnotic drugs, or explore the full manufacturer portfolio for Sanofi.

Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
Therapeutic class benchmarking — See how Ambien ranks within Non-Benzodiazepine Hypnotic on serious event rates.
Company portfolio risk — View all drugs from Sanofi with aggregate risk exposure.
AI analyst briefs — Get a natural-language safety assessment combining all data sources.