Adult safety & tolerability
Simtriyo demonstrated a consistent safety and tolerability profile across multiple clinical trials1,2
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Common adverse events in adults1
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Adverse events in ≥5% of adult patients treated with Simtriyo and greater than placebo in pooled, 6-week, placebo-controlled ADHD studies1
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Placebo
(N=290)
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Simtriyo [br-m] 200 mg TDD*
(N=294)
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Simtriyo [br-m] 400 mg TDD*
(N=292)
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Headache
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7%
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5%
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8%
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Decreased appetite
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2%
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5%
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light-orange
7%
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Insomnia
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4%
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5%
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light-orange
7%
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Nausea
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2%
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light-blue
2%
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light-orange
7%
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Dry mouth
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0%
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light-blue
3%
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6%
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Diarrhea
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1%
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2%
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light-orange
5%
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Additional adverse reactions that occurred in ≥2% of adult patients treated with Simtriyo and greater than placebo included irritability, rash, abdominal pain, parasomnia, tachycardia, depressed mood, anxiety, and upper respiratory tract infection.
In adult studies of Simtriyo-treated patients, 6% taking 400 mg TDD and 5% taking 200 mg TDD discontinued treatment because of an adverse event, compared to 1% of placebo-treated patients.1 Compared to 1% of placebo-treated patients, 2% of Simtriyo-treated patients experienced anxiety.1
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*There are no expected differences in the safety of Simtriyo 210 mg and 280 mg once daily compared to the low and high doses of the adult study formulation, respectively, for the treatment of ADHD in adults.
TDD=total daily dose.
TDD=total daily dose.
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Could Simtriyo help patients like Seth?
Seth, age 52,† has struggled with ADHD since his childhood diagnosis. See what other ADHD challenges patients like Seth may be struggling with.
See challenges
†Hypothetical patient.
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A different way to treat ADHD
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Treat with the trio
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Simtriyo has the potential for abuse and misuse. Even though Simtriyo is a CNS stimulant, clinical studies suggest it does not produce physical dependence.1
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Simtriyo has class-related warnings for cardiovascular effects. In clinical trials, tachycardia was reported in 2% of adults compared with 1% of patients taking placebo, and there was no clinically meaningful effect on the QT interval.1
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Over 52 weeks in the adult OLE trial there was a low incidence of AEs and there were no new safety findings.3‡
‡The most common adverse reactions in adults included headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea.
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AE=adverse event; CNS=central nervous system; OLE=open-label extension.
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TOLERABLE THROUGHOUT TREATMENT
Through 52 weeks of an open-label extension study, Simtriyo [br-d] demonstrated a safety and [br-d] tolerability profile consistent with [br-d] short-term studies3
This study found3:
- No new safety findings
- A low overall incidence of serious adverse events
Of the 61.4% of patients who experienced an adverse event, most were mild (45%) or moderate (36.1%). The most common treatment-emergent adverse events were insomnia, nausea, diarrhea, and headache.3
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Learn More
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Designed with the patient in mind
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Simtriyo makes ADHD treatment simple with once-daily dosing. And, for most patients, the starting dose is the therapeutic dose.1
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Simple, once-daily treatment
Read the dosing information to learn how to prescribe Simtriyo.
See dosing
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Designed for your pediatric patients, too
Explore how the Simtriyo safety data stacks up in children and adolescent patients.
see safety data
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References
- Simtriyo Prescribing Information. Otsuka America Pharmaceutical, Inc. 2026.
- Adler LA, et al. Efficacy, safety, and tolerability of centanafadine sustained-release tablets in adults with attention-deficit/hyperactivity disorder: results of 2 phase 3, randomized, double-blind, multicenter, placebo-controlled trials. J Clin Psychopharmacol. [br-m] 2022;42(5):429-439.
- Mattingly GW, et al. 52-week open-label safety and tolerability study of centanafadine sustained release in adults with attention-deficit/hyperactivity disorder. J Clin Psychopharmacol. 2025;45(5):454-462.
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