Generic Name

Qelbree

Mechanism

• Selective Norepinephrine Reuptake Inhibition (SNRI):
• Viloxazine blocks the norepinephrine transporter (NET) with high affinity, increasing synaptic norepinephrine levels.
• Enhanced norepinephrine improves prefrontal cortical activity, supporting attention, executive functioning, and impulse control.
• Pharmacological Profile
• Low affinity for dopamine or serotonin transporters → reduced risk of abuse or serotonin syndrome.
• Minimal CNS stimulant pharmacodynamics, offering tolerance‑free symptom control.

Pharmacokinetics

• Absorption
• Oral bioavailability ≈ 87 %.
• Peak plasma concentration (Tmax) 3–4 h post‑dose.
• Distribution
• Protein binding ~ 35 %.
• Metabolism
• Predominantly hepatic via CYP2D6 and CYP3A4; minor glucuronidation.
• No clinically relevant drug‑drug interactions with CYP2C19 inhibitors.
• Elimination
• Half‑life ≈ 10–12 h (steady‑state ~ 1–2 days).
• ~ 95 % excreted unchanged in urine, < 5 % in feces.
• Special Populations
• Dose adjustments: No routine changes in mild‑moderate hepatic impairment; avoid in severe hepatic disease.

Indications

• Adult ADHD (≥ 18 years).
• Pediatric ADHD:
• Children and adolescents 6–12 years.
• Children 3–5 years (labeled in some regions).
• Exclusion: Not indicated for narcolepsy or other sleep disorders.

Contraindications

• Contraindications
• Hypersensitivity to viloxazine or excipients.
• Uncontrolled hypertension or ischemic heart disease.
• Warnings
• Hypertension & Cardiovascular: Monitor BP/HR; dose titration in patients with mild‑moderate hypertension.
• Suicidality: As with all psychostimulants/SNRIs, report emergent suicidal ideation or behavior.
• QT Prolongation: Rare, but monitor QT in patients on concurrent QT‑extending agents.
• Serotonergic Toxicity: Avoid concomitant SSRIs or MAOIs unless cleared by specialist.

Dosing

• Administration: Oral, preferably at the same time each day.
• Food Effect: Food increases bioavailability modestly; no strict timing required.

Monitoring

• Baseline:
• BP, HR, weight, growth velocity (peds).
• Mental status (suicidality check).
• During Treatment:
• BP/HR every 2–4 weeks initially; thereafter every 3–6 months.
• Weight & growth %iles annually in children.
• Adverse effect profile (sleep, appetite changes).
• Lab: No routine labs; consider thyroid and liver panels if clinically indicated.

Clinical Pearls

• Non‑stimulant Edge: Qelbree offers a non‑stimulant alternative for patients who cannot tolerate methylphenidate or amphetamines or who have a history of substance misuse.
• Pediatric Safety: In children, the risk of growth suppression common with stimulants is not observed, making Qelbree a favourable choice when growth abnormalities are a concern.
• Drug–Drug Interactions: Minimal interaction with CYP3A4 inhibitors/inducers; however, caution with potent CYP2D6 inhibitors (e.g., fluoxetine) which may increase plasma levels.
• Adherence Support: Once‑daily dosing improves adherence vs. multiple daily doses of stimulant medications.
• Psychiatric Co‑Morbidity: Qelbree can be used concomitantly with anxiolytics, antipsychotics, and antidepressants provided dosages are monitored—unlike stimulants that may amplify anxiety or mania.
• Dosing Flexibility: The incremental titration schedule allows clinicians to adjust dose to the patient’s tolerability and response, thereby minimizing side‑effect burden.

*Use Qelbree as part of a comprehensive ADHD management plan including behavioral therapy, psychoeducation, and regular follow‑ups.*