FDA changes buprenorphine labeling to favor higher doses

Following upon more than a year of urging from the American Society of Addiction Medicine (ASAM), the National Institute on Drug Abuse (NIDA), and many clinicians in the field, there has been one definitive step toward resolving confusion in doses of buprenorphine. Initially a maximum of 32 milligrams a day was recommended. This then went down to 16. Many providers started with 8. In the era of illicit fentanyl, these doses were not enough, and even in patients not using fentanyl, they may not be enough to prevent craving. In fact, the labeling does not have a maximum daily dose, but there is a “misperception” that it does, the Food and Drug Administration (FDA) stated in a holiday‐week announcement that received little coverage (our January 6 issue was the annual preview/review issue which does not include current news).