Reviews Overview: Simtriyo is used to treat attention deficit hyperactivity disorder (ADHD). Common side effects include decreased appetite, trouble sleeping, dry mouth, or headache. Simtriyo carries risks for misuse and dependence. Store Simtriyo in a safe place to protect it from theft. Tell your health care provider right away if you have sudden changes in mood or behavior after starting Simtriyo. If you are about to harm yourself, call 911 or call or text 988 to reach the Suicide & Crisis Lifeline
Uses
What is Simtriyo used for?
Simtriyo (centanafadine) is commonly used for attention deficit hyperactivity disorder (ADHD), which is a condition that affects attention, focus, and self-control.
Simtriyo may also be used for other conditions as determined by your health care provider.
How does Simtriyo work (mechanism of action)?
Simtriyo is part of a group of medicines called stimulants. It may work by increasing levels of natural brain chemicals, such as norepinephrine, dopamine, and serotonin. These chemicals play a role in attention, alertness, and wakefulness.
How is Simtriyo supplied (dosage forms)?
Brands and other names
- Simtriyo
Dosage forms and strengths
- 140 mg, 210 mg, 280 mg extended-release oral capsules
How should I store Simtriyo?
Simtriyo should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.
Side Effects
What are the most common side effects of Simtriyo?
The most common side effects of Simtriyo are listed below. These side effects may vary depending on the age of the person taking it. Tell your health care provider if you have any of these side effects that bother you.
- Decreased appetite
- Headache
- Dry mouth (adults)
- Stomach pain (children)
- Nausea
- Diarrhea (adults)
- Rash (children)
- Trouble sleeping (adults)
There may be other side effects of Simtriyo that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Simtriyo?
While less common, the most serious side effects of Simtriyo are described below, along with what to do if they happen.
Severe Allergic Reactions. Simtriyo may cause allergic reactions, which can be serious. Stop taking Simtriyo and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching or skin rash
- Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Suicidal Thoughts or Actions. Simtriyo may increase the risk of suicidal thoughts or actions in a small number of children. This is more likely to happen within the first few months of taking Simtriyo. Keep all appointments with your health care provider while taking Simtriyo. If your child is about to harm themselves, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your health care provider right away if your child has any of the following symptoms.
- New or increased thoughts of suicide or death
- Suicide attempt
- New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior
Risk of Misuse and Addiction. Simtriyo has the potential to be misused or abused. Misuse means taking a medicine in a way other than how it was prescribed. Misusing Simtriyo can lead to an overdose or death. This risk may be increased with higher doses. Take Simtriyo exactly as prescribed. Do not change your dose without your health care provider instructing you to do so. Tell your health care provider if you feel that Simtriyo is not working.
Mental Health Problems. Simtriyo may cause or worsen mania, hallucinations, or psychotic-like behaviors. Tell your health care provider right away if you have any of the following symptoms, or if you have been told by others you have these symptoms.
- Hearing, seeing, smelling, tasting, or otherwise perceiving things that others do not
- Delusional thoughts, such as false beliefs that you are being controlled
- Disorganized thoughts, such as jumping between topics or having a hard time focusing
- Aggressive, angry, or violent behavior
- Very increased energy
- Significant trouble sleeping
- Racing, fast-paced thoughts
- Reckless behavior
- Unusually grand ideas
- Excessive happiness or irritability
- Talking more or faster than usual
- Strong unusual and uncontrolled urges or behaviors, including gambling, sex, shopping, or eating
Blood Flow Problems. Simtriyo may cause a condition called Raynaud's phenomenon, which occurs when the blood vessels in your fingers and toes overreact and lead to low blood flow. Call your health care provider right away if you have any of the following symptoms.
- Fingers or toes feeling numb, cool, painful, or sensitive to cold
- Fingers or toes changing color from pale, to blue, to red
- Unexplained wounds on fingers or toes
Serotonin Syndrome.Serotonin syndrome is when there is too much of a substance called serotonin in your body. Simtriyo can cause serotonin syndrome when it is taken with other medicines that affect serotonin. This condition can be life-threatening. Get emergency help if you have any of the following symptoms of serotonin syndrome.
- Sweating, fever, or flushing
- Confusion
- Feeling agitated or restless
- Seeing or hearing unusual things
- Dizziness
- Fast or racing heartbeat
- Nausea, vomiting, or diarrhea
- Muscle twitching, stiffness, or tremor
- Seizures
Tics. Central nervous system (CNS) stimulants may cause or worsen tics, which are sudden, repetitive movements or sounds. Call your health care provider right away if you get tics or existing tics seem to get worse.
Increased Blood Pressure or Heart Rate. Simtriyo may increase your heart rate or blood pressure. Keep all appointments with your health care provider to check your blood pressure and heart rate before starting Simtriyo and during treatment. Also call your health care provider or get medical attention right away if you have chest pain or a fast heartbeat or if you faint or feel your heartbeat more than usual.
Warnings & Precautions
Who should not use Simtriyo?
Allergies to Ingredients. People who are allergic to any of the following should not take Simtriyo.
- Centanafadine
- Simtriyo
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Simtriyo.
Drug Interactions. Simtriyo should not be taken while you are using certain other medicines. Before taking Simtriyo, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pheochromocytoma. Simtriyo should not be taken if you have or have a history of pheochromocytoma. Taking it may lead to serious blood pressure and heart rate problems if you have or have a history of pheochromocytoma.
What should I know about Simtriyo before using it?
Do not take Simtriyo unless it has been prescribed to you by a health care provider. Take it as prescribed.
Take Simtriyo around the same time each morning. Taking it later in the day could make it harder to sleep at night. Talk to your health care provider if you have any questions about how to take Simtriyo.
Do not share Simtriyo with other people, even if they have the same condition as you. It may harm them.
Keep Simtriyo out of the reach of children.
Do not crush, cut, or chew Simtriyo capsules. Ideally they should be swallowed whole. If you cannot swallow the capsule whole, it can be opened and sprinkled over a tablespoonful of applesauce, yogurt, or in a tablespoon of orange juice. Swallow the mixture right away, without chewing. Drink some water right after swallowing the mixture. Do not store the mixture for later use.
Children taking Simtriyo may be at a higher risk of not gaining height and weight as expected. Keep all appointments with your health care provider to check your child’s height and weight before starting and during treatment with Simtriyo. Talk to your child’s health care provider if you have concerns.
If you need to dispose of unused or expired Simtriyo, bring it to a medicine take-back program at an authorized collection site, such as a pharmacy or police station. If no take-back program is available, mix it with a nontoxic and unattractive substance such as dirt, cat litter, or used coffee grounds and place it in a container like a sealed plastic bag. Throw away the mixture in household trash. Ask your pharmacist or other health care provider if you are not sure how to throw away this medicine safely.
What should I tell my health care provider before using Simtriyo?
Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Simtriyo is right for you.
In particular, make sure that you discuss any of the following.
Aspirin or Dye Allergies. Some Simtriyo capsules contain FD&C Yellow No. 5 (tartrazine). If you are sensitive to this particular dye or to aspirin, you may be more likely to react to certain Simtriyo capsules. Talk to your health care provider about any aspirin or dye sensitivities before taking Simtriyo.
Substance Use Disorder. Simtriyo has the potential to be misused or abused. Tell your health care provider if you have substance use disorder or if you have ever misused alcohol, prescription medicines, or street drugs.
Mental Health Problems. Tell your health care provider if you or anyone in your family has had mental health problems, including psychosis, bipolar disorder, mania, depression, or suicide. Simtriyo may worsen certain mental health conditions.
Heart Problems. If you have serious heart disease or heart defects you may be at risk of sudden death if you take Simtriyo. Tell your health care provider if you have any heart problems, including heart disease, heart defects, cardiomyopathy, or an abnormal heart rhythm (arrhythmia). Also tell your health care provider if anyone in your family has heart problems.
Current and Past Health Conditions. Tell your health care provider if you have any of the following.
- High blood pressure
- Blood flow problems in your fingers or toes, such as Raynaud’s
- Personal or family history of tics or Tourette’s syndrome
- Liver problems
Pregnancy. It is not known if or how Simtriyo could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant. If you become pregnant while taking Simtriyo, you can sign up for the National Pregnancy Registry for ADHD Medications by calling 866-961-2388 or at womensmentalhealth.org/research/pregnancyregistry/adhd-medications. This registry collects safety information about the use of certain medicines during pregnancy.
Breastfeeding. It is not known if Simtriyo passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take Simtriyo while breastfeeding.
How can I get more information about Simtriyo?
For more information about Simtriyo, you can visit the drugmaker’s website at www.simtriyo.com or call them at 833-468-7852.
Interactions
Does Simtriyo interact with foods or drinks?
There are no known interactions between Simtriyo and foods or drinks.
Avoid drinking alcohol with or within 2 hours of taking Simtriyo. Drinking alcohol with or within 2 hours after taking Simtriyo may cause a faster release of your dose. This can cause higher levels of Simtriyo in your blood and increase the risk of side effects. Talk to your health care provider if you have concerns.
Does Simtriyo interact with other medicines (drug interactions)?
Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking Simtriyo.
- A monoamine oxidase inhibitor (MAOI) within the past 2 weeks, which is a medicine usually used for depression or Parkinson’s disease
- A selective serotonin reuptake inhibitor (SSRI), such as fluoxetine, paroxetine, or sertraline, which is a medicine commonly used for anxiety and depression
- A serotonin and norepinephrine reuptake inhibitor (SNRI), such as duloxetine or venlafaxine, which is a medicine commonly used for anxiety and depression
- A tricyclic antidepressant, such as amitriptyline, nortriptyline, or protriptyline, even if it is not used for depression
- A triptan, such as eletriptan (Relpax), sumatriptan (Imitrex and others), and others, which is a medicine commonly used to treat migraines
- An opioid, such as codeine, fentanyl, meperidine, methadone, morphine, oxycodone, or tramadol, which is a medicine used to treat certain types of pain
- St. John’s wort, which is a supplement that may be used for depression
- Tryptophan or L-tryptophan, which is a supplement that may be used to help the body make proteins and certain brain-signaling chemicals that may be used to help with mood or sleep
- A stimulant, such as amphetamine, methylphenidate, or lisdexamfetamine, which is a medicine commonly used to treat attention deficit hyperactivity disorder (ADHD)
Simtriyo may alter the blood levels of some other medicines. Tell your health care provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Simtriyo. Always check with your health care provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Simtriyo?
If you or someone else has used too much Simtriyo, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Simtriyo?
If you miss a dose and it is within 4 hours of when you normally take it, take the dose as soon as you remember it. If it has been more than 4 hours since you would normally take it, skip the missed dose and take your next dose at the usual time. Do not take double or extra doses. Do not take more than one dose each day.
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