The definition of a standard US drink (above) isn’t changing, but what constitutes an effective med for alcohol use disorder is
New FDA guidelines shift alcohol approvals toward the harm-reduction model
STUDY: Bramness JG et al, Eur Addict Res 2026
STUDY TYPE: Editorial
FUNDING: Independent
Background
On February 14, 2025, the FDA changed the standard for medication approvals in alcohol use disorder, requiring a reduction in drinking rather than total abstinence. Specifically, treatments must lower alcohol intake by at least two levels in the World Health Organization (WHO) Risk Drinking Levels.
The old standard excluded many patients who couldn’t or wouldn’t pursue abstinence and made it hard to appreciate medications like naltrexone and nalmefene that reduce drinking without eliminating it.
This editorial reviews the decision, drawing on 27 observational studies and 7 pharmacotherapy trials showing that drinking reductions produce meaningful health benefits. Here are some highlights:
- Moving down at least two WHO risk levels correlates with lower rates of alcohol dependence, improved liver function, fewer psychiatric symptoms, better quality of life, and less healthcare use.
- In three phase III trials, the reduced-drinking endpoint produced comparable or larger effect sizes than abstinence-based outcomes, with higher overall response rates.
- Only one in six patients with alcohol use disorder currently receives adequate treatment, and abstinence-only goals likely contribute to that gap.
Practice Implications
- This change brings approvals more in line with the realities of practice.
- Reducing drinking is a legitimate goal, and more achievable for some patients.
- Although the standard applies to alcohol, a new paper re-analyzed trials in cocaine use disorders with the harm-reduction standard, and found meaningful efficacy with the dopamine agonist cabergoline.
— Chris Aiken, MD
Director, Psych Partners
Editor in Chief, Carlat Psychiatry Report
