ADHD FAQs - COTEMPLA XR-ODT

ADHD FAQs

We created some questions and answers to help you and your child along the journey.

A diagnosis of ADHD can bring both relief and apprehension. It is important to know that it isn’t your child’s fault. Nor is it your fault. ADHD is a medical condition that can be treated. While there is no cure for ADHD, there are many resources and tools that can help you, your child, and your family better understand how to treat and manage your child’s ADHD symptoms.¹²

Reference 12: Cleveland Clinic. Attention‑Deficit/Hyperactivity Disorder (ADHD). Cleveland Clinic Health Library. Last reviewed March 12, 2025. Accessed December 16, 2025. https://my.clevelandclinic.org/health/diseases/4784-attention-deficithyperactivity-disorder-adhd

FAQs

This list of FAQs can help you understand ADHD, available treatments, and COTEMPLA XR-ODT specifically. Consult with your child’s doctor regarding questions around ADHD and treatment options.

What are the various treatments used for ADHD?¹³

There are two main types of ADHD medications: stimulant and non-stimulant medications. Medications also come in several different forms to meet the different needs of patients. This includes orally disintegrating tablets (ODTs), liquids, patches, capsules and tablets. Before medication treatment begins, your child’s doctor should discuss the benefits and the possible side effects of these medications.

Reference 13: Understood Team. Types of ADHD Medications. Understood.org. Accessed December 16, 2025. https://www.understood.org/en/articles/types‑of‑adhd‑medications

Do ADHD treatments cure ADHD?¹⁴

Medications for ADHD can be very effective but they are not a cure for ADHD. Medications can help children control his or her ADHD symptoms on the day the medication is taken. If a child does not take their medication, you should not expect to see improvement in their symptoms. Treatment for ADHD varies with each patient, and a treatment plan that includes ADHD medication may help your child manage this condition.

Reference 14: Children and Adults with Attention‑Deficit/Hyperactivity Disorder (CHADD). Medication Management. CHADD. Accessed December 16, 2025. https://chadd.org/for-adults/medication-management/

How can I know that my child has ADHD?¹⁵

At times, many children can have trouble focusing and paying attention. All kids make careless mistakes in their school work…or forget to do their homework from time to time. Children with ADHD have significantly more challenges in their concentration, impulsivity, and hyperactivity that can negatively impact them at school and at home. If you are concerned that your child might have ADHD, make an appointment with his or her doctor.

Reference 15: Children and Adults with Attention‑Deficit/Hyperactivity Disorder (CHADD). About ADHD – Overview. CHADD. Accessed December 16, 2025. https://chadd.org/about‑adhd/overview/

What is COTEMPLA XR-ODT?¹⁶

COTEMPLA XR-ODT (methylphenidate) is an extended-release orally disintegrating tablet approved for the treatment of ADHD in children ages 6 to 17. “Extended release” means the active drug is released in the body throughout the day. ODT means “orally disintegrating tablet.” COTEMPLA XR-ODT dissolves quickly in the mouth so that your child does not need to swallow it whole and can be taken without water.

Reference 16: Kaiser Permanente. Cotempla XR‑ODT 17.3 mg Extended‑Release Disintegrating Tablet. Kaiser Permanente. Accessed December 17, 2025. https://healthy.kaiserpermanente.org/health-wellness/drug-encyclopedia/drug.cotempla-xr-odt-17-3-mg-extended-release-disintegrating-tablet.594128

WARNING: ABUSE, MISUSE, AND ADDICTION

COTEMPLA XR-ODT has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including COTEMPLA XR-ODT, can result in overdose and death, and this risk is increased with higher doses of unapproved methods of administration, such as snorting or injection.

Before prescribing COTEMPLA XR-ODT, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout COTEMPLA XR-ODT treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

Can COTEMPLA XR-ODT Improve attention and reduce the symptoms of hyperactivity and lmpulsivity?¹⁷

Yes. In a clinical study, COTEMPLA XR-ODT was shown to work fast and improve attention and behavior throughout the day. Learn more about the COTEMPLA XR-ODT clinical study by clicking here. It is important to remember that everybody is different and results will vary from patient to patient.

Reference 17: https://healthy.kaiserpermanente.org/health-wellness/drug-encyclopedia/drug.cotempla-xr-odt-17-3-mg-extended-release-disintegrating-tablet.594128

How does an orally disintegrating tablet differ from a traditional pill?¹⁸

An orally disintegrating tablet (ODT) dissolves quickly in the mouth without water.

Reference 18: Tho I. Smeltetabletter–fordeler og ulemper [Orally disintegrating tablets–advantages and drawbacks]. Tidsskr Nor Laegeforen. 2012;132(4):424-425. doi:10.4045/tidsskr.10.1464. https://pubmed.ncbi.nlm.nih.gov/22353836/

How long will my child need to take medication?¹⁹

The course of treatment with ADHD medications depends on the individual patient’s situation and response to overall treatment. Your child’s doctor may talk to you about trial periods without medication to assess your child’s response to treatment. Your child’s doctor will talk to you about the risks and benefits of stopping treatment.

Reference 19: Cleveland Clinic. ADHD Medication: How They Work & Side Effects. Cleveland Clinic Health Library. Last reviewed October 6, 2022. Accessed December 17, 2025. https://my.clevelandclinic.org/health/treatments/11766‑adhd‑medication

How quickly can I expect COTEMPLA XR-ODT to work in my child?²⁰

COTEMPLA XR-ODT is a stimulant medication. Many researchers and clinicians believe that stimulant medications like COTEMPLA XR-ODT can have an immediate effect on ADHD symptoms. Of course, all patients are different and results will vary from patient to patient.

Reference 20: Mental Health America. Stimulant Medications. Mental Health America. Accessed December 17, 2025. https://screening.mhanational.org/content/stimulant-medications/

What types of side effects are most common with ADHD medications?²¹

There are many different ADHD medications available for patients with ADHD. Each medication has a unique side effect profile. Click here to learn more about the side effects patients experienced while taking COTEMPLA XR-ODT in our clinical study. Your child’s doctor will be able to provide you with information on the most common side effects of other ADHD medications.

Reference 21: Cleveland Clinic. ADHD Medication: How They Work & Side Effects. Cleveland Clinic Health Library. Last reviewed October 6, 2022. Accessed December 17, 2025. https://my.clevelandclinic.org/health/treatments/11766-adhd-medication

What If I suspect an accidental overdose In my child?²²

If you suspect an accidental overdose of COTEMPLA XR-ODT, call your child’s doctor or poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.

Reference 22: Neos Therapeutics, Inc; U.S. Food and Drug Administration. ADZENYS XR‑ODT (amphetamine) Extended‑Release Orally Disintegrating Tablets: Prescribing Information. Revised April 2025. Accessed December 17, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204326s018lbl.pdf

What Important safety Information should I know about COTEMPLA XR-ODT?

Review Important Safety Information and the patient Medication Guide.

Important Safety Information

WARNING: ABUSE, MISUSE, AND ADDICTION

Indication

COTEMPLA XR-ODT is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

Limitations of Use

The use of COTEMPLA XR-ODT is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage.

Contraindications

Known hypersensitivity to methylphenidate or other ingredients in COTEMPLA XR-ODT. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate products.
Concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within a minimum of 14 days following discontinuation of treatment with a monoamine oxidase inhibitor because of the risk of hypertensive crisis.

Warnings and Precautions

Abuse, Misuse, and Addiction: COTEMPLA XR-ODT has a high potential for abuse and misuse. The use of COTEMPLA XR-ODT exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. COTEMPLA XR-ODT can be diverted for non-medical use into illicit channels or distribution. Misuse and abuse of CNS stimulants, including COTEMPLA XR-ODT, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing COTEMPLA XR-ODT, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, and proper disposal of any unused drug. Advise patients to store COTEMPLA XR-ODT in a safe place, preferably locked, and instruct patients not to give COTEMPLA XR-ODT to anyone else. Throughout COTEMPLA XR-ODT treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
Risks to Patients with Serious Cardiac Disease: Sudden death has occurred in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosages. Avoid COTEMPLA XR-ODT use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.
Increased Blood Pressure and Heart Rate: CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mm Hg) and heart rate (mean increase approximately 3 to 6 bpm). Some patients may have larger increases. Monitor all COTEMPLA XR-ODT-treated patients for hypertension and tachycardia.
Psychiatric Adverse Reactions: Exacerbation of Pre-Existing Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder CNS stimulants may induce a manic or mixed episode in patients. Prior to initiating COTEMPLA XR-ODT treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression). New Psychotic or Manic Symptoms CNS stimulants, at the recommended dosage, may cause psychotic or manic symptoms (e.g. hallucinations, delusional thinking or mania) in patients without a prior history of psychotic illness or mania. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared to 0% of placebo-treated patients. If such symptoms occur, consider discontinuing COTEMPLA XR-ODT.
Priapism: Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate use in both adult and pediatric male patients. Although priapism was not reported with methylphenidate initiation, it developed after some time on methylphenidate, often after an increase in dosage. Priapism also occurred during methylphenidate withdrawal (drug holidays or during discontinuation). COTEMPLA XR-ODT-treated patients who develop abnormally sustained or frequent and painful erections should see immediate medical attention.
Peripheral Vasculopathy, including Raynaud’s Phenomenon: CNS stimulants, including COTEMPLA XR-ODT, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports and at therapeutic dosages of CNS stimulants in all age groups throughout the course of treatment. Signs and symptoms generally improved after dosage reduction or discontinuation of the CNS stimulant. Careful observation for digital changes is necessary during COTEMPLA XR-ODT treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for COTEMPLA XR-ODT-treated patients who develop signs or symptoms of peripheral vasculopathy.
Long-Term Suppression of Growth in Pediatric Patients: COTEMPLA XR-ODT is not approved for use and is not recommended in pediatric patients below 6 years of age. CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Careful follow-up of weight and height in pediatric patients ages 7 to 10 years who were randomized to either methylphenidate or nonmedication-treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and nonmedication-treated pediatric patients over 36 months (to the ages of 10 to 13 years), suggests that pediatric patients who received methylphenidate for 7 days per week throughout the year had a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this development period. Closely monitor growth (weight and height) in COTEMPLA XR-ODT-treated pediatric patients who are not growing or gaining height and weight as expected may need to have their treatment interrupted.
Acute Angle Closure Glaucoma: There have been reports of angle closure glaucoma associated with methylphenidate treatment. Although the mechanism is not clear, COTEMPLA XR-ODT-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.
Increased Intraocular Pressure and Glaucoma: There have been reports of an elevation of intraocular pressure (IOP) associated with methylphenidate treatment. Prescribe COTEMPLA XR-ODT to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor COTEMPLA XR-ODT-treated patients with a history of abnormally increased IOP or open angle glaucoma.
Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported. Before initiating COTEMPLA XR-ODT, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor COTEMPLA XR-ODT-treated patients for the emergence or worsening of tics or Tourette’s syndrome and discontinue treatment if clinically appropriate.

Adverse Reactions

Adverse Reactions in Studies with Other Methylphenidate Products in Children, Adolescents, and Adults with ADHD: Commonly reported (≥2% of the methylphenidate group and at least twice the rate of the placebo group) adverse reactions from placebo-controlled trials of methylphenidate products include:

Appetite decreased
Weight decreased
Nausea
Abdominal pain
Dyspepsia
Dry mouth
Vomiting
Insomnia
Anxiety
Nervousness
Restlessness
Affect lability
Agitation
Irritability
Dizziness
Vertigo
Tachycardia
Palpitations
Hyperhidrosis
Pyrexia
Tremor
Blurred Vision
Blood pressure increased
Heart rate increased

Adverse Reactions in Studies with COTEMPLA XR-ODT in Children with ADHD: There is limited experience with COTEMPLA XR-ODT in controlled trials. Based on this limited experience, the adverse reaction profile of COTEMPLA XR-ODT appears similar to other methylphenidate extended release-products.

Drug Interactions

Monoamine Oxidase Inhibitors (MAOI): Concomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Do not administer COTEMPLA XR-ODT concomitantly with MAOIs or within 14 days after discontinuing MAOI treatment.
Gastric pH Modulators: May change the release profile and alter the pharmacodynamics of COTEMPLA XR-ODT. Concomitant use of COTEMPLA XR-ODT with a gastric pH modulator (i.e., a H2-blocker or a proton pump inhibitor) is not recommended.
Antihypertensive Drugs: COTEMPLA XR-ODT may decrease the effectiveness of drug used to treat hypertension. Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed.
Halogenated Anesthetics: Concomitant use of halogenated anesthetics and COTEMPLA XR-ODT may increase the risk of sudden blood pressure and heart rate increase during surgery. Avoid use of COTEMPLA XR-ODT in patients being treated with anesthetics on the day of surgery.
Risperidone: Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in dosage of either or both medications, may increase the risk of extrapyramidal symptoms (EPS). Monitor for signs of EPS.

Pregnancy and Lactation

Fetal/Neonatal adverse reactions: CNS stimulants, such as COTEMPLA XR-ODT, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.
Lactation: Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.

Pediatric Use

The safety and effectiveness of COTEMPLA XR-ODT have not been established in pediatric patients below the age of 6 years. In studies evaluating extended-release methylphenidate products, patients 4 to <6 years of age had higher systemic methylphenidate exposures than those observed in older pediatric patients at the same dosage. Pediatric patients 4 to <6 years of age also had a higher incidence of adverse reactions, including weight loss.

The safety and effectiveness of COTEMPLA XR-ODT have been established in pediatric patients 6 to 17 years of age in one adequate and well-controlled study in pediatric patients 6 to 12 years, pharmacokinetic data in adolescents, and safety information from other methylphenidate-containing products.

Please click here for Full Prescribing Information.