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About ADHD

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About ADHD

Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental condition, characterized by inattention, hyperactivity and impulsivity, that affects children and adults worldwide. ADHD is often a seriously impairing and persistent condition.1

Although most often diagnosed during childhood, patients with ADHD have waxing and waning symptoms, with 90% of patients with childhood ADHD continuing to experience symptoms into adulthood.2

ADHD Symptoms and Diagnosis

ADHD is a heterogeneous disorder and symptoms vary among individuals. The diagnosis of ADHD requires a clinical interview about core symptoms and impairments following the guidelines of either the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, of the American Psychiatric Association (DSM-5) or the International Classification of Diseases 11th edition (ICD-11).1

According to the DSM-5, ADHD presents in 1 of 3 ways:

Hyperactive and Impulsive ADHD Boy Yelling

Predominantly hyperactive-impulsive

Inattentive Only ADHD Girl Falls Asleep During School

Predominantly inattentive

Boy With Combined Inattentive, Hyperactive, Impulsive ADHD Balances Pencil

Combined

Symptoms are divided into two categories of inattention and hyperactivity-impulsivity that include behaviors like failure to pay close attention to details, difficulty organizing tasks and activities, excessive talking, fidgeting, or an inability to remain seated in appropriate situations. Children must have at least six symptoms from either (or both) the inattention group of criteria and the hyperactivity and impulsivity criteria, while older adolescents and adults (over age 17 years) must have at least five. Please click here for additional information on the DSM-5 criteria for diagnosing ADHD.

ADHD Treatment and Management1,3-7

Treatments for ADHD include medication, psychosocial interventions, education or training, or a combination of treatments.

Treatment plans should be individualized to help the patient control symptoms, cope with the disorder, and manage relationships.7

Several different types of medications are FDA-approved to treat ADHD:

  • Stimulants are the most widely used ADHD medications. These include methylphenidate and amphetamine medications.
  • Nonstimulants include atomoxetine, viloxazine, guanfacine, and clonidine.

ADHD medications can affect patients differently and can have common side effects such as decreased appetite or sleep problems. Healthcare providers may need to switch treatment or adjust the dose to find the right balance between benefits and side effects.

Tris Pharma Medical

Clinical Resources

Please visit TrisMedical.com for in-depth clinical information and a wide variety of resources on ADHD and related conditions.

Is a methylphenidate right for my patient?

Quillivant XR methylphenidate HCl for extended-release oral suspension 25mg/5mL Logo #1 Quillivant XR, the first once-daily, long-acting* liquid methylphenidate treatment
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Once-daily liquid methylphenidate
Learn more about
Quillivant XR

Deciding whether to prescribe a methylphenidate such as Quillivant XR, depends largely on the individual needs of the patient, prior patient response or lack of response to methylphenidate or amphetamine, and patient preference for liquid vs tablet formulation.

Before prescribing Quillivant XR, 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 Quillivant XR treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

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References: 1. Faraone SV, Bellgrove MA, Brikell I, et al. Attention-deficit/hyperactivity disorder. Nature reviews disease primers. (2024); 10:11: https://doi.org/10.1038/s41572-024-00495-0 2. Sibley MH, Arnold LE, Swanson JM, Hechtman LT, Kennedy TM, Owens E, Molina BSG, Jensen PS, Hinshaw SP, Roy A, Chronis-Tuscano A, Newcorn JH, Rohde LA; MTA Cooperative Group. Variable Patterns of Remission From ADHD in the Multimodal Treatment Study of ADHD. Am J Psychiatry. 2022 Feb;179(2):142-151. doi: 10.1176/appi.ajp.2021.21010032. Epub 2021 Aug 13. PMID: 34384227; PMCID: PMC8810708. 3. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, 5th edition. Arlington, VA., American Psychiatric Association, 2013. 4. Faraone SV. The pharmacology of amphetamine and methylphenidate: Relevance to the neurobiology of attention-deficit/hyperactivity disorder and other psychiatric comorbidities. Neurosci Biobehav Rev. 2018 Apr;87:255-270. 5. Treatment of ADHD. Available at: https://www.cdc.gov/adhd/treatment/index.html 6. Miller C, Taskiran S. Child Mind Institute. What are Non-Stimulant Medications for ADHD? Available at: https://childmind.org/article/what-are-nonstimulant-medications-for-adhd/ 7. CHADD website. Treatment of ADHD. Available at: https://chadd.org/about-adhd/treatment-of-adhd/

IMPORTANT SAFETY INFORMATION

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WARNING: ABUSE, MISUSE, AND ADDICTION

Quillivant XR 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 Quillivant XR, can result in overdose and death. Before prescribing Quillivant XR 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 treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

IMPORTANT SAFETY INFORMATION

INDICATION

Quillivant XR® (methylphenidate HCI) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

WARNING: ABUSE, MISUSE, AND ADDICTION

Quillivant XR 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 Quillivant XR, can result in overdose and death. Before prescribing Quillivant XR, 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 treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

  • Quillivant XR is contraindicated:
    • in patients known to be hypersensitive to methylphenidate or other components of Quillivant XR. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported.
    • during concomitant treatment with monoamine oxidase inhibitors (MAOIs), and within 14 days following discontinuation of treatment with an MAOI because of the risk of hypertensive crisis.
  • Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD doses. Serious cardiovascular effects with overdose may precipitate sudden cardiac death. Prior to treating patients with Quillivant XR, assess for the presence of cardiac disease. Avoid Quillivant XR use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during treatment with Quillivant XR.
  • CNS stimulants cause an increase in blood pressure (mean increase approximately 2 - 4 mm Hg) and heart rate (mean increase approximately 3 - 6 bpm). Some individuals may have larger increases. Monitor all patients for hypertension and tachycardia.
  • Use of CNS stimulants may cause exacerbation of pre-existing psychosis and may induce a manic or mixed episode in patients with bipolar disorder. In patients without prior history of psychotic illness or mania, CNS stimulants may cause new psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) at the recommended dosage. Prior to initiating Quillivant XR treatment, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing Quillivant XR.
  • Cases of priapism have been reported with methylphenidate use and also during a period of withdrawal in both adult and pediatric male patients. Immediate medical attention should be sought in Quillivant XR treated patients who develop abnormally sustained or frequent and painful erections.
  • CNS stimulants including Quillivant XR used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for Quillivant XR-treated patients who develop signs or symptoms of peripheral vasculopathy.
  • CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Growth should be monitored during treatment with stimulants, including Quillivant XR. Patients who are not growing or gaining weight as expected may need to have their treatment interrupted.
  • Quillivant XR-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.
  • Quillivant XR should be prescribed to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Close monitoring of patients with a history of increased IOP or open angle glaucoma is necessary.
  • CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics and worsening of Tourette’s syndrome. Before initiating Quillivant XR, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome. Discontinue treatment if clinically appropriate.
  • Based on accumulated data from other methylphenidate products, the most common (≥5% and twice the rate of placebo) adverse reactions are:
    • Appetite decreased
    • Insomnia
    • Nausea
    • Vomiting
    • Dyspepsia
    • Abdominal pain
    • Weight decreased
    • Anxiety
    • Dizziness
    • Irritability
    • Affect Lability
    • Tachycardia
    • Blood pressure increased
  • There is limited experience with Quillivant XR in controlled trials. The most common (≥2% in the Quillivant XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 45 ADHD patients (ages 6-12 years) in Quillivant XR compared to placebo were affect lability (9% Quillivant XR, 2% placebo), excoriation (4%, 0%), initial insomnia (2%, 0%), tic (2%, 0%), decreased appetite (2%, 0%), vomiting (2%, 0%), motion sickness (2%, 0%), eye pain (2%, 0%), and rash (2%, 0%).
  • There are limited studies on the use of methylphenidate in pregnant women. However, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. To monitor pregnancy outcomes in women exposed to ADHD medications during pregnancy, healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.
  • The developmental and health benefits of breastfeeding should be considered along with a mother’s clinical need for Quillivant XR and any potential adverse effects on the breastfed infant from Quillivant XR or from the underlying maternal condition. Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.
  • To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at (732) 940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information for Quillivant XR, including Boxed Warning regarding Abuse, Misuse, and Addiction.

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