What Was Approved?
On July 24, 2026, the U.S. Food and Drug Administration approved Simtriyo (centanafadine) extended-release capsules for the treatment of attention-deficit/hyperactivity disorder, or ADHD.
Simtriyo is approved for:
- Adults with ADHD
- Pediatric patients 6 years of age and older who weigh at least 20 kg
The FDA labeling does not recommend its use in children younger than 6 years or in children weighing less than 20 kg.
What Is Simtriyo?
Simtriyo contains centanafadine, a medication that affects the activity of several neurotransmitters in the brain.
The FDA-approved label describes centanafadine as a norepinephrine-dopamine-serotonin reuptake inhibitor and a central nervous system stimulant.
It is intended to help manage symptoms of ADHD as part of an individualized treatment plan.
How Is Simtriyo Taken?
Simtriyo is an extended-release capsule taken once daily in the morning.
It may be taken with or without food.
According to the FDA-approved prescribing information, the capsule may be swallowed whole. In certain situations, the capsule may also be opened and the entire contents sprinkled on applesauce or yogurt, or placed in orange juice, following the product instructions.
The dose varies by age, weight, clinical response, and tolerability.
Does Simtriyo Have a Boxed Warning?
Yes.
Simtriyo carries an FDA boxed warning addressing two important safety concerns.
Suicidal Ideation and Behaviors in Pediatric Patients
In clinical studies, higher rates of suicidal thoughts and behaviors were observed in Simtriyo-treated children ages 6 to 12 compared with placebo.
The FDA labeling instructs healthcare professionals to closely monitor pediatric patients for the emergence of suicidal ideation or behavior.
Abuse, Misuse, and Addiction
Simtriyo is a central nervous system stimulant and has the potential for abuse, misuse, and addiction.
The prescribing information recommends assessing a patient’s risk before treatment and monitoring for signs of misuse or addiction during therapy.
What Are the Common Side Effects?
Common adverse reactions differed somewhat by age group in the clinical studies.
In adults, commonly reported adverse reactions included:
- Headache
- Decreased appetite
- Insomnia
- Nausea
- Dry mouth
- Diarrhea
In pediatric patients, reported common adverse reactions included decreased appetite, rash, nausea, headache, and abdominal pain, depending on the age group studied.
Not every patient will experience these effects.
What Other Safety Issues Should Patients Know About?
The FDA labeling includes several additional warnings and precautions.
These include possible:
- Increases in blood pressure and heart rate
- Psychiatric adverse reactions
- Serious allergic reactions
- Reduced growth or weight gain in pediatric patients
- Peripheral circulation problems, including Raynaud’s phenomenon
- Serotonin syndrome
- New or worsening motor or verbal tics
Healthcare professionals may monitor blood pressure, heart rate, growth, psychiatric symptoms, and other clinical factors during treatment.
Who Should Not Take Simtriyo?
According to the FDA-approved prescribing information, Simtriyo is contraindicated in certain patients, including those with:
- A known hypersensitivity to centanafadine or the product’s ingredients
- Current use of a monoamine oxidase inhibitor, or use within the previous 14 days
- Pheochromocytoma or a history of pheochromocytoma
Additional medical conditions and medications may also affect whether Simtriyo is appropriate.
Are There Important Drug or Alcohol Considerations?
Yes.
The FDA label advises avoiding alcohol at the same time as Simtriyo and for at least two hours after taking a dose.
Simtriyo can also interact with certain medications, including other central nervous system stimulants and some drugs affected by CYP1A2.
Patients should provide their prescriber and pharmacist with a complete list of prescription medicines, over-the-counter products, and supplements.
Why Is This Approval Important?
Simtriyo adds another FDA-approved treatment option for ADHD and is considered a novel drug, meaning its active ingredient had not previously been approved in the United States.
Its distinct pharmacologic profile may provide clinicians with another option when selecting ADHD treatment based on an individual patient’s age, symptoms, medical history, and treatment response.
Bottom Line
Simtriyo (centanafadine) is a newly FDA-approved once-daily extended-release medication for ADHD in adults and in children age 6 and older who weigh at least 20 kg.
Because it carries important warnings—including risks involving suicidal ideation in pediatric patients and abuse, misuse, and addiction—treatment requires appropriate screening, monitoring, and follow-up with a healthcare professional.
Sources
- U.S. Food and Drug Administration (FDA) — Novel Drug Approvals for 2026.
- U.S. Food and Drug Administration (FDA) — Simtriyo (centanafadine) Prescribing Information, revised July 2026.
- U.S. Food and Drug Administration (FDA) — Simtriyo Approval Letter.