FDA Approves Simtriyo, a New Type of Stimulant, for Adults and Children With ADHD

The FDA has approved Simtriyo (centanafadine) to treat attention deficit hyperactivity disorder, also known as ADHD. It is approved for adults, as well as children who are 6 years of age and older and weigh at least 44 pounds (20 kilograms). ADHD is a brain condition that can cause problems with paying attention, staying organized, or controlling impulsive behavior.

Simtriyo is a type of medicine known as a central nervous system (CNS) stimulant. It works by increasing three natural brain chemicals: norepinephrine, dopamine, and serotonin. These chemicals play a key role in attention and behavior. Increasing their levels may help to improve symptoms of ADHD.

Why Was Simtriyo Approved?

The FDA approval was based on four clinical studies. Two studies tested the medicine in adults with ADHD, and two studies tested it in children and teenagers. In these studies, researchers compared Simtriyo with a placebo (a pill that contains no medicine).

During the studies, ADHD symptoms were measured by health care providers using standard ADHD rating scales. In all four studies, people taking Simtriyo showed greater improvements in their ADHD symptoms, compared to those taking the placebo. Improvements in attention and behavior were seen as early as the first week of treatment in both adults and children.

Common side effects like skin rashes, reduced appetite, nausea, and headaches were reported more often in people taking Simtriyo than in those taking the placebo. In children, the medicine caused weight loss and slower growth over time.

What Do I Need to Know About Taking Simtriyo?

Simtriyo is a capsule that is taken once a day in the morning, with or without food. If you or your child is unable to swallow the capsule, you can open it and sprinkle the contents onto one tablespoon of applesauce, yogurt, or orange juice. Swallow the mixture right away without chewing. Avoid drinking alcohol for at least two hours after your dose because alcohol can cause the medicine to release too quickly.

This medicine has important safety warnings. It carries a warning for higher rates of suicidal thoughts and behaviors in children ages 6 to 12 years. Families and caregivers should watch children closely for any unusual mood or behavior changes. Simtriyo also carries a risk of abuse, misuse, and addiction, which can lead to severe health issues.

The most common side effects in children include skin rashes, decreased appetite, nausea, headaches, and stomach pain. Adults most commonly have headaches, a lower appetite, trouble sleeping, nausea, a dry mouth, and diarrhea. Simtriyo can also raise your heart rate and blood pressure. Tell your health care provider right away if you feel chest pain or have signs of a severe allergic reaction, such as swelling or trouble breathing.

Before starting treatment, tell your health care provider if you have a history of heart disease, high blood pressure, mental health conditions, or Tourette syndrome. Also let them know them about all medicines or supplements you take, including stimulants and antidepressants. Some medicines and supplements can have serious interactions with Simtriyo.