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Nearly half of female veterans use zolpidem inappropriately

Almost 50% of female veterans were taking higher than recommended doses of zolpidem, despite drug safety warnings from the FDA and the Veterans Health Administration recommending against high doses, according to findings recently published in the Journal of Clinical Sleep Medicine.

“In light of growing evidence of substantial risk associated with zolpidem use and lack of additional hypnotic efficacy at higher doses, the Department of Veterans Affairs Pharmacy Benefits Management Services released a bulletin in May 2007 recommending that zolpidem be used at doses no greater than 10 mg per day,” Hyungjin Myra Kim, ScD, of Consulting for Statistics at the University of Michigan and colleagues wrote. “In August 2007, zolpidem was placed on the Veterans Health Affairs prescription formulary,” they continued.

According to the researchers, the FDA issued a drug safety warning in January 2013 about zolpidem regarding risk for next-morning impairment, and also recommended lower doses.

Researchers also wrote that in May 2013, the FDA approved label changes for lower zolpidem dosing: for women, recommendations are 5 mg of immediate-release formulations and 6.25 mg of extended-release formulations; for men, the recommendations are 5 mg or 10 mg for immediate-release formulations and 6.25 mg or 12.5 mg for the extended-release formulations.

Almost 50% of female veterans were taking higher than recommended doses of zolpidem, despite drug safety warnings from the FDA and the Veterans Health Administration recommending against high doses.

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Kim and colleagues assessed how the VA and FDA warnings impacted monthly outpatient use of higher-than-recommended doses of zolpidem among 27,123 zolpidem users (13,314 women) from 2005 to 2014 and any-dose zolpidem during the same time period.

Researchers found that though high-dose zolpidem use declined after each warning, 48.3% of female zolpidem recipients had high-dose zolpidem use in 2014.

“[This] is concerning in light of significant harms associated with high dose. Given the different formulations of zolpidem and different recommendations by sex, it is possible that prescribers were confused about recommended zolpidem prescribing,” Kim and colleagues wrote.

Researchers also found that overall zolpidem use nearly quadrupled between the two warnings, but declined after the 2013 FDA warning. However, overall zolpidem use in November 2014 was 3.7% in women and 2.6% for men, which was still higher than the level before the 2007 Veterans Affairs warning. In addition, sensitivity analyses of zolpidem’s possible substitutes revealed differences in the level of use by sex for all comparison drug classes.

In a related commentary, Sabra S. Inslicht, PhD, and Thomas C. Neylan, MD, both of the department of psychiatry at the University of California, San Francisco, wrote that the findings serve as a timely reminder that not all medications are created equal when it comes to gender.

“The study by Kim and colleagues highlights the need to pay attention to sex-specific research findings and changes in treatment guidelines, and improve strategies to educate newer treatment guidelines to providers. Their work is particularly salient with respect to the increase in sex-specific research trials being conducted and with the likelihood of additional sex-specific dosage recommendations that may be warranted in the future. This will be a critical area of growth for providers who may be less accustomed to caring for female patients in a setting that has seen a dominantly male patient population,” they wrote.

“Given that women represent the fastest growing segment of veterans seeking care it will be important to understand how to address the needs of women veterans and provide more tailored sex-specific care,” Inslicht and Neylan concluded. – by Janel Miller

Disclosure: The authors report no relevant financial disclosures.