FDA-Approved SSRIs for PTSD
Only sertraline and paroxetine have FDA approval for the treatment of post-traumatic stress disorder (PTSD). 1, 2, 3, 4, 5, 6, 7, 8, 9
Key Points
Sertraline and paroxetine are the sole SSRIs with FDA indication for PTSD, based on large-scale, well-designed placebo-controlled trials that demonstrated efficacy 5
While fluoxetine has shown efficacy in controlled trials for chronic PTSD 2, 4, it does not have FDA approval for this indication
No other SSRIs (citalopram, escitalopram, fluvoxamine) have FDA approval for PTSD
Clinical Context
These are the only two medications of any class approved by the FDA specifically for PTSD 6, 8. Despite decades of research and numerous trials with other agents, sertraline and paroxetine remain the only pharmacologic options with regulatory approval for this indication.
Evidence Base
The approval of sertraline and paroxetine was based on their demonstrated effectiveness in multiple rigorous clinical trials showing:
- Superiority over placebo in reducing PTSD symptoms
- Acceptable safety profiles
- Benefits maintained with continuation treatment for 6-12 months 4
Important Caveat
While fluoxetine has substantial evidence supporting its use in PTSD and is commonly prescribed off-label for this condition 2, 3, 4, it lacks FDA approval. The distinction matters for insurance coverage, medicolegal considerations, and informed consent discussions with patients.
Treatment duration should be at least 12 months, and likely much longer—potentially 2 years or more given the risks of untreated PTSD 3.