New ADHD Medications 2026: What Families Should Know

If you have heard that a new ADHD medication was approved this year, you heard right. This post covers what the FDA approved in 2026, a safety labeling change that matters for young children, and why a new medication is not automatically the right one for you or your child.

What Is New in ADHD Medications in 2026?

The main news is Simtriyo (centanafadine), approved by the FDA on July 24, 2026. In our review of FDA and manufacturer sources covering the past 18 months, it is the only newly approved ADHD medication we found.

Two other developments are worth knowing. In June 2025, the FDA required new safety labeling on extended-release ADHD stimulants. And in June 2026, the FDA sent a complete response letter on another once-daily ADHD stimulant still in development, CTx-1301, which means it is not approved and not available.

Simtriyo (Centanafadine): A New Type of ADHD Medication

Here is what the manufacturer, Otsuka, and the FDA label say:

• Class: a norepinephrine, dopamine, serotonin reuptake inhibitor, or NDSRI. It is the first medication of this type approved for ADHD.

• Form: a once-daily extended-release capsule.

• Approved for: adults, and children age 6 and older who weigh at least 44 pounds (20 kg). It is not recommended for children under 6.

• Approval: July 24, 2026, supported by four placebo-controlled phase 3 trials in children, teens and adults. In those trials, ADHD symptom scores improved more than with placebo.

• Common side effects: in adults, headache, decreased appetite, trouble sleeping, nausea, dry mouth and diarrhea. In children and teens, decreased appetite, nausea, rash, headache and abdominal pain.

• Boxed warnings: higher rates of suicidal thoughts and behaviors in children ages 6 to 12 taking it, and a risk of abuse, misuse and addiction.

• Availability: not yet. As of this writing, the manufacturer says it is waiting for the U.S. Drug Enforcement Administration (DEA) to set its controlled substance schedule.

Is Simtriyo a Non-Stimulant ADHD Medication?

Many news stories called centanafadine a non-stimulant. The FDA label does not. It describes Simtriyo as a central nervous system stimulant, and it will be a controlled substance once the DEA acts.

This matters for families who are looking for a non-stimulant option, perhaps because of sleep, appetite or worries about misuse. Non-stimulant ADHD medications already exist, such as atomoxetine and guanfacine. Ask your provider which class a medication belongs to, and do not rely on the headline.

New Safety Labeling for Extended-Release Stimulants in Young Children

On June 30, 2025, the FDA required changes to the labels of all extended-release ADHD stimulants. The FDA found that children younger than 6 taking these medications had higher levels of the drug in their bodies and a greater risk of weight loss and other side effects than older children on the same dose.

Extended-release stimulants are not approved for children younger than 6. If your child is that young and taking one, the FDA advises parents to contact their health care professional if they notice weight loss. Do not stop a medication on your own. Your provider can talk through options, which may include other medications or behavior therapy.

What "New" Does Not Mean

FDA approval means a medication worked better than a placebo in studies and has an acceptable safety profile for its approved use. It does not mean it works better than the medications you may already know.

One psychiatrist who reviewed all of the Simtriyo trials in Psychology Today in August 2026 noted that no head-to-head trial against any other ADHD medication has been run. So no one can say yet whether it is better, the same or worse than what is already available. Older medications have years of real-world use behind them.

The right choice depends on the person: age, other health conditions, sleep, appetite, heart health, family history, other medications, cost and insurance coverage. Some people do well on a medication that has been around for decades. Some need a change. Neither is a failure.

ADHD Medication Management in Volusia County

BFF Clinic provides ADHD evaluation and treatment for children, teens and adults, as part of our psychiatric services, with virtual and in-person visits. We offer care in English, Spanish and Portuguese.

If you have questions about your current ADHD medication or about what is new, we are glad to talk it through. Call 386-424-3320 or contact the clinic to book an appointment.

This post is general information, not medical advice. Medication decisions are made with a provider after a full evaluation.