Making a ‘sex-difference fact’: Ambien dosing at the interface of policy, regulation, women’s health, and biology

• Published in: Social studies of science Vol. 53; no. 4; pp. 475 - 494
• Main Authors: Zhao, Helen, DiMarco, Marina, Ichikawa, Kelsey, Boulicault, Marion, Perret, Meg, Jillson, Kai, Fair, Alexandra, DeJesus, Kai, Richardson, Sarah S.
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01-08-2023; Sage Publications Ltd
• Subjects: Advocacy; Biology; Biomedicine; Documents; Dosage; Drugs; Female; Healthy food; Humans; Male; Mass media effects; Media coverage; Policy; Regulatory agencies; Sex Characteristics; Sex differences; Stabilization; United States; United States Food and Drug Administration; Women; Women's Health; Womens health; Zolpidem; United States; drug regulation; women’s health; SABV; zolpidem; sex differences; scientific facts
• ISSN: 0306-3127; 1460-3659
• DOI: 10.1177/03063127231168371

The U.S. Food and Drug Administration’s (FDA) 2013 decision to lower recommended Ambien dosing for women has been widely cited as a hallmark example of the importance of sex differences in biomedicine. Using regulatory documents, scientific publications, and media coverage, this article analyzes the making of this highly influential and mobile ‘sex-difference fact’. As we show, the FDA’s decision was a contingent outcome of the drug approval process. Attending to how a contested sex-difference fact came to anchor elite women’s health advocacy, this article excavates the role of regulatory processes, advocacy groups, and the media in producing perceptions of scientific agreement while foreclosing ongoing debate, ultimately enabling the stabilization of a binary, biological sex-difference fact and the distancing of this fact from its conditions of construction.