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Impact of FDA Safety Warning on Dispensed Zolpidem Dose for Women

Friday, May 30, 2014

Debra Irwin imageThe television show recently aired a segment about gender differences in rates of drug metabolism. The program discussed a recent , one of the most popular insomnia medications on the market. The safety warning was based on new data that showed women metabolize Zolpidem more slowly than men. Hence, women would require a lower dose of Zolpidem in order to avoid next morning impairment. After viewing this episode, my colleague and I became interested in the impact that the FDA safety warning had on Zolpidem dispensing patterns.

We examined the dose dispensed to new Zolpidem users before and after the FDA safety warning was issued. Women who were new users of Zolpidem were significantly more likely to receive low-dose Zolpidem after the safety warning compared to women who were new users of Zolpidem in the time period before the safety warning. However, the overall proportion of women receiving low-dose Zolpidem after the safety warning remained quite low.

Our findings may have significant public health implications for women using Zolpidem. An alarmingly high proportion of women who were new Zolpidem users were dispensed high-dose Zolpidem, despite the FDA safety warning. These findings highlight the importance of the extensive communication efforts required to effectively disseminate information concerning drug label changes to healthcare providers and patients.

Read more in our new issues brief, .

Debra Irwin
Research Leader