About Attention Deficit Hyperactivity Disorder (ADHD)

ADHD is a common neurodevelopmental condition, characterized by inattention, hyperactivity and impulsivity

ADHD affects children and adults worldwide, and 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:

Predominantly <span class='whitespace-nowrap'>hyperactive-impulsive</span>

Predominantly hyperactive-impulsive

Predominantly inattentive

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 Management^1,3-7

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 clonidine, atomoxetine, viloxazine, and guanfacine.

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.

Clinical Resources

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

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REFERENCES: 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

ONYDA™ XR (clonidine HCI) is a centrally acting alpha2-adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older.

See Additional Important Safety Information.

INDICATION

IMPORTANT SAFETY INFORMATION

Contraindications:

ONYDA XR is contraindicated in patients with history of a hypersensitivity reaction to clonidine.

Warnings & Precautions:

Hypotension/Bradycardia: Treatment with ONYDA XR can cause dose-related decreases in blood pressure and heart rate. Titrate slowly and monitor vital signs frequently in patients at risk for hypotension, heart block, bradycardia, syncope, cardiovascular disease, vascular disease, cerebrovascular disease, or chronic renal failure. In patients who have a history of syncope or may have a condition that predisposes them to syncope, such as hypotension, orthostatic hypotension, bradycardia, or dehydration, advise patients to avoid becoming dehydrated or overheated.
Somnolence/Sedation: Somnolence and sedation were commonly reported adverse reactions in clinical studies with clonidine hydrochloride extended-release tablets. Caution patients against operating heavy equipment or driving until they know how they respond to treatment with ONYDA XR. Advise patients to avoid use with alcohol.
Rebound Hypertension: Abrupt discontinuation of ONYDA XR can cause rebound hypertension. Withdrawal symptoms include headache, tachycardia, nausea, flushing, warm feeling, brief lightheadedness, tightness in chest, and anxiety. To minimize the risk of rebound hypertension, gradually reduce the dose of ONYDA XR in decrements of no more than 0.1 mg every 3 to 7 days Patients should be instructed not to discontinue ONYDA XR therapy without consulting their physician due to the potential risk of withdrawal effects.
Cardiac Conduction Abnormalities:: The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. There have been post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring intravenous (IV) atropine, IV isoproterenol, and temporary cardiac pacing while taking clonidine. Titrate ONYDA XR slowly and monitor vital signs frequently in patients with cardiac conduction abnormalities or patients concomitantly treated with other sympatholytic drugs.

Adverse Reactions:

Most common adverse reactions (incidence at least 5% and twice the rate of placebo) as monotherapy in ADHD: somnolence, fatigue, irritability, nightmare, insomnia, constipation, dry mouth.
Most common adverse reactions (incidence at least 5% and twice the rate of placebo) as adjunct therapy to psychostimulant in ADHD: somnolence, fatigue, decreased appetite, dizziness.

Clinically Important Drug Interactions:

CNS Depressants: Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates, or other sedating drugs. Avoid concomitant use of CNS depressants with ONYDA XR.
Tricyclic Antidepressants: Concomitant use of tricyclic antidepressants with clonidine can increase blood pressure and may counteract the hypotensive effects of clonidine. Monitor blood pressure and adjust dosage of ONYDA XR as needed.
Drugs Known to Affect Sinus Node Function or AV Nodal Conduction: Avoid use of ONYDA XR with agents known to affect sinus node function or AV nodal conduction (e.g., digitalis, calcium channel blockers, and beta-blockers) due to a potential for additive effects such as bradycardia and AV block.
Antihypertensive Drugs: Concomitant use of antihypertensive drugs with clonidine potentiates the hypotensive effects of clonidine. Monitor blood pressure and heart rate and adjust dosage of ONYDA XR accordingly in patients treated concomitantly with antihypertensives.

Use in Specific Populations:

Use in Patients with Renal Impairment: The impact of renal impairment on the pharmacokinetics of clonidine in pediatric patients has not been assessed. The dosage of ONYDA XR must be adjusted according to the degree of impairment, and patients should be carefully monitored.
Use During Pregnancy: Prolonged experience with clonidine in pregnant women over several decades, based on published literature—including controlled trials, a retrospective cohort study, and case reports—has not identified a drug-associated risk of major birth defects, miscarriage, and adverse maternal or fetal outcomes.
To monitor pregnancy outcomes in women exposed to ADHD medications, including ONYDA XR, during pregnancy, healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/adhd-medications/.
Use During Lactation: The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ONYDA XR and any potential adverse effects on the breastfed child from ONYDA XR or from the underlying maternal condition. Monitor breastfeeding infants exposed to ONYDA XR through breast milk for symptoms of hypotension and/or bradycardia such as sedation, lethargy, tachypnea, and poor feeding.

To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see ONYDA XR PI for Full Prescribing Information.