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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 an amphetamine right for my patient?

Amphetamine Treatments

DYANAVEL XR Tablet amphetamine extended-release tablets 5mg, 10mg, 15mg, 20mg Logo Once Daily DYANAVEL XR extended release
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DYANAVEL XR tablet
DYANAVEL XR Liquid amphetamine extended-release oral suspension 2.5 mg/mL Logo/mL Logo #1 DYANAVEL XR extended release oral suspension
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Once-daily liquid amphetamine
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DYANAVEL XR liquid

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

Before prescribing DYANAVEL 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 DYANAVEL 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/ncbddd/adhd/treatment.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

DYANAVEL 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 DYANAVEL XR, can result in overdose and death. Before prescribing DYANAVEL 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

DYANAVEL® XR (amphetamine) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

WARNING: ABUSE, MISUSE, AND ADDICTION

DYANAVEL 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 DYANAVEL XR, can result in overdose and death. Before prescribing DYANAVEL 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..

  • DYANAVEL XR is contraindicated:
    • in patients known to be hypersensitive to amphetamine, or other components of DYANAVEL XR. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported with other amphetamines.
    • in patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of increased 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 DYANAVEL XR, assess for the presence of cardiac disease. Avoid DYANAVEL 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 DYANAVEL XR treatment.
  • CNS stimulants cause increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Monitor all patients for potential tachycardia and hypertension.
  • 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 DYANAVEL XR treatment, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing DYANAVEL XR.
  • CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients with ADHD; monitor weight and height during treatment with DYANAVEL XR. Treatment may need to be interrupted in children not growing as expected.
  • CNS stimulants, including DYANAVEL XR, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; 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 DYANAVEL XR-treated patients who develop signs or symptoms of peripheral vasculopathy.
  • Serotonin syndrome risk is increased when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), MAOIs, and during overdosage situations. If it occurs, discontinue DYANAVEL XR and any concomitant serotonergic agents immediately, and initiate supportive treatment.
  • CNS stimulants, including amphetamine, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported. Before initiating DYANAVEL XR, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor DYANAVEL XR-treated patients for the emergence or worsening of tics or Tourette’s syndrome and discontinue treatment if clinically appropriate.
  • Most common adverse reactions observed with amphetamine products: dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, and tachycardia. Based on limited experience with DYANAVEL XR in controlled trials, the adverse reaction profile of DYANAVEL XR appears similar to other amphetamine extended-release products. The most common (≥2% in the DYANAVEL XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 108 patients with ADHD (aged 6 to 12 years) were: epistaxis (DYANAVEL XR 4%, placebo 0%), allergic rhinitis (4%, 0%) and upper abdominal pain (4%, 2%).
  • DYANAVEL XR use during pregnancy may cause fetal harm. To monitor pregnancy outcomes in women exposed to DYANAVEL XR 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/.
  • Because of the potential for serious adverse reactions in a breastfed infant, breastfeeding is not recommended during treatment with DYANAVEL XR.
  • 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 DYANAVEL XR including Boxed Warning regarding Abuse, Misuse, and Addiction.

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