News of Note
FDA Approves Centanafadine (Simtriyo) for ADHD
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We need medications for patients who don’t respond well to existing ADHD medications. When a genuinely novel agent is released, we try to set aside our skepticism and look at the evidence before judging its place in practice.
Centanafadine, a new extended-release capsule approved by the FDA for ADHD in patients age 6 and older, is a norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI)—a “triple reuptake inhibitor” unlike familiar stimulants and non-stimulants.
Approval rested on four trials spanning adults, adolescents, and children (full side effect and warning details appear in the Quick Facts table). It currently awaits the DEA’s controlled-substance scheduling review and is expected to ultimately be scheduled.
Centanafadine’s half-life is 5.2 hours; recommended monitoring includes blood pressure, pulse, and liver function tests. See table for more details.
| Centanafadine (Simtriyo) Quick Facts | |
|---|---|
| FDA Indications | ADHD (age 6 and older). |
| Off-Label Uses | None established yet. |
| Other Uses | Not studied in depression, but centanafadine is an enantiomer of amitifadine, which has shown positive trials for depression. |
| Dosage | 140 mg once daily in the morning (20–34 kg); 210 mg once daily (35–50 kg); 280 mg once daily (> 50 kg ages 6–12, or > 20 kg ages 13–17). Extended-release capsules may be opened but should not be crushed or chewed; this would destroy the extended-release mechanism, risking high peak levels and side effects. |
| Side Effects | Most common: Headache, abdominal pain, decreased appetite, fatigue, nausea, insomnia, and rash. Serious but rare: Class warnings for suicidal ideation in children and teens, and for potential abuse, misuse, and dependence. |
| Interactions | Metabolized primarily by the liver (non-P450 pathways). Avoid use with monoamine oxidase inhibitors, other antidepressants, and stimulants. |
| Cost | Not yet available; awaiting DEA controlled-substance scheduling review. |
From the News of Note
“FDA Approves Centanafadine (Simtriyo) for ADHD”
by Talia Puzantian, PharmD, BCPP
The Carlat Child Psychiatry Report, Volume 17, Number 7 & 8
October/November/December 2026
www.thecarlatreport.com
CARLAT TAKE
Centanafadine is promoted as a triple reuptake inhibitor, but binding data suggest it’s predominantly a norepinephrine reuptake inhibitor, with weaker effects at the other transporters. Like other non-stimulants, its effect sizes are roughly half of stimulants’, yet the label classifies it as a stimulant. Post-hoc analyses suggest improved executive function and emotional dysregulation, and an industry-funded indirect comparison suggests better tolerability than stimulants, atomoxetine, and viloxazine, a finding needing independent replication. The lack of head-to-head data against first-line agents, plus its pending controlled-substance status, makes centanafadine a third-line option—requiring careful monitoring—for children who haven’t responded to or tolerated stimulants or existing non-stimulants, or in situations where lower misuse potential is desired.
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