Sex Differences in the Effects of Pharmaceutical Products (2020)
This case study traces the story of Ambien (zolpidem), from early signs of sex-based differences in drug absorption that went unexamined in 1992, to the FDA's 2013 decision to halve the recommended dose for women.
This piece will help inform how this widely publicized episode exposed gaps in how sex differences are studied in drug development, and why the pharmaceutical industry still has work to do to ensure clinical trials adequately capture how drugs affect men and women differently.