Off-label prescribing — when FDA-approved medications are used to treat conditions that they are not approved for — is widespread in the U.S. health care system. In fact, about 1 in 5 prescriptions written are for off-label use, most commonly when FDA-approved treatments have not worked or do not exist. But at what cost?

A new study published in Health Affairs Scholar, UCLA Center for Health Policy Research Senior Economist Srikanth Kadiyala, PhD, and co-authors look at the uses of trazodone, a drug approved in 1981 to treat depression, as a case study to examine broader issues surrounding off-label use and spending. Although only approved to treat depression, trazodone is often prescribed off-label to treat insomnia and anxiety.

Using data from the 2019 Medical Expenditure Panel Survey, researchers found that approximately 24 million prescriptions were filled for trazodone at a total cost of $294 million in 2019. However, at least 85% of prescriptions (about 20 million) and 84% of total health care spending (nearly $247 million) were for off-label uses. Off-label use of trazodone for sleep disorders accounted for nearly $195 million of that spending, despite the fact that trazodone’s effectiveness on sleep is unknown. 

The authors note that a high-quality randomized trial to measure the effectiveness of trazodone on sleep can be conducted for significantly less than total spending on trazodone in just one year.

Join us on Wednesday, August 13, as researchers share findings from the study and discuss policy solutions to make off-label prescribing more evidence-based and cost-effective.