Ambien Class Action Wins FDA Warning Reforms
Susan Chana Lask
Federal Ambien Litigation Leading to FDA Safety Warning Enhancements
In March 2006, civil rights and consumer protection attorney Susan Chana Lask filed a federal class action lawsuit in the United States District Court for the Southern District of New York against Sanofi-Aventis, the manufacturer of the prescription sleep medication Ambien (zolpidem). The complaint alleged that existing product warnings failed to adequately disclose serious sleep-related behavioral risks associated with the drug.
On March 14, 2007, the U.S. Food and Drug Administration (FDA) announced that it directed Sanofi-Aventis and other sleep-medication manufacturers to strengthen safety warnings and issue enhanced risk communications to healthcare providers and consumers. These warnings addressed complex sleep-related behaviors, including sleep-driving, sleep-eating, and other dangerous activities performed while not fully awake.
After the FDA implemented warning reforms, Ms. Lask voluntarily dismissed the federal class action without prejudice on May 29, 2007, having achieved the litigation’s core objective: improved consumer safety disclosures. The dismissal preserved the right of individual consumers to pursue personal claims if warranted.
Ms. Lask did not receive compensation from this litigation. The case was pursued as a public-interest effort to advance pharmaceutical accountability and patient safety.
FDA-Identified Ambien Safety Risks
- Sleep-driving and impaired judgment
- Sleep-eating and unsafe nighttime behaviors
- Performing complex activities while not fully conscious
The FDA also required manufacturers to distribute Medication Guides to patients and issue formal safety communications to prescribing physicians.
Media Coverage and Public Awareness
Ms. Lask raised national awareness through media appearances, including MSNBC coverage on March 6, 2006, contributing to broader public discussion regarding sleep-medication risks, pharmaceutical warning standards, and consumer protection.
By 2012, publications including Marie Claire referenced the litigation while examining Ambien-related safety concerns. Ms. Lask maintains these risks affect patients regardless of gender.
Watch: Susan Chana Lask on Ambien Litigation
Related Resources
- FDA Safety Announcement (2007) — Ambien warning expansion
- Federal Case Filing — SDNY Index No. 06-CV-1672
- Official Website: https://appellate-brief.com
