QELBREE

Clinical safety rating: caution

Comprehensive clinical and safety monograph for QELBREE (QELBREE).

How it works

Qelbree (viloxazine) is a selective norepinephrine reuptake inhibitor (NRI) believed to exert its therapeutic effects by increasing norepinephrine levels in the prefrontal cortex, which enhances attention and reduces impulsivity/hyperactivity.

What the body does with it

Metabolism	Primarily metabolized by CYP1A2, with minor contributions from CYP2D6 and CYP3A4. Major metabolite is 5-hydroxy-viloxazine (active).
Excretion	Primarily hepatic metabolism (CYP3A4-mediated) with <1% excreted unchanged in urine. Fecal elimination accounts for ~55% of the dose as metabolites; renal excretion accounts for ~40% as metabolites.
Half-life	Terminal elimination half-life is approximately 14-17 hours in adults, supporting once-daily dosing. Steady-state is achieved within 7 days.
Protein binding	Plasma protein binding is approximately 80%, primarily to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	Volume of distribution is approximately 0.4 L/kg, indicating distribution into total body water.
Bioavailability	Oral bioavailability is approximately 95% (absolute). Food does not affect bioavailability but may delay Tmax by 1-2 hours.
Onset of Action	Oral: Improvement in ADHD symptoms may be observed within 1 week of starting therapy, with full effect typically seen by 4-6 weeks.
Duration of Action	Duration of action is approximately 24 hours with once-daily oral administration, consistent with clinical efficacy throughout the day.

Classification & Brands

Dosing & administration

Initial: 0.5 mg orally once daily. Titrate by 0.5 mg increments every 2-3 days based on efficacy and tolerability to a maximum dose of 4 mg once daily. Target dose 2-4 mg once daily.

Dosage form	CAPSULE, EXTENDED RELEASE
Renal impairment	No specific dose adjustment recommended for mild-to-moderate renal impairment. Not studied in severe renal impairment (eGFR <30 mL/min/m2); use with caution.
Liver impairment	Child-Pugh Class A: No adjustment. Child-Pugh Class B: Reduce dose by 50%; maximum dose 2 mg once daily. Child-Pugh Class C: Not recommended.
Pediatric use	Approved for children ≥6 years. Starting dose 0.2 mg (or 0.6 mg if patient is switching from another methylphenidate-based product) orally once daily. Titrate by 0.2 mg increments weekly; maximum 4 mg/day for patients 6-17 years.
Geriatric use	Limited data. No specific dosage adjustment provided; initiate at low end of dosing range (0.5 mg once daily) and titrate cautiously due to potential for increased sensitivity.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for QELBREE (QELBREE).

Breastfeeding	No data on presence in human milk, effects on breastfed infant, or milk production. M/P ratio unknown. Caution advised; consider benefits of breastfeeding, risk of infant drug exposure, and maternal need.
Teratogenic Risk	Limited human data; animal studies show no evidence of teratogenicity at clinically relevant doses. Risk cannot be excluded; use only if potential benefit justifies potential risk.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Qelbree carries a black box warning for increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults taking antidepressants. Patients should be closely monitored for clinical worsening, suicidality, or unusual changes in behavior.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Concomitant use with monoamine oxidase inhibitors (MAOIs) or within 14 days of MAOI use","Hypersensitivity to viloxazine or any excipient","Use in patients with uncontrolled hypertension or tachyarrhythmias (relative)"]

Clinical Precautions

Precautions

["Suicidality risk: Monitor for suicidal ideation/behavior, especially early in treatment.","Blood pressure and heart rate: May cause increases; monitor baseline and periodically.","Activation of mania/hypomania: Screen for bipolar disorder prior to use.","Seizures: Use with caution in patients with seizure disorders.","Angle-closure glaucoma: May precipitate an acute attack.","Hepatic impairment: Use with caution; dose adjustment may be needed.","Renal impairment: Not recommended in severe renal impairment."]

Clinical Tips & Counseling

Drug interactions

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QELBREE

Clinical safety rating: caution

Comprehensive clinical and safety monograph for QELBREE (QELBREE).

How it works

What the body does with it

Metabolism	Primarily metabolized by CYP1A2, with minor contributions from CYP2D6 and CYP3A4. Major metabolite is 5-hydroxy-viloxazine (active).
Excretion	Primarily hepatic metabolism (CYP3A4-mediated) with <1% excreted unchanged in urine. Fecal elimination accounts for ~55% of the dose as metabolites; renal excretion accounts for ~40% as metabolites.
Half-life	Terminal elimination half-life is approximately 14-17 hours in adults, supporting once-daily dosing. Steady-state is achieved within 7 days.
Protein binding	Plasma protein binding is approximately 80%, primarily to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	Volume of distribution is approximately 0.4 L/kg, indicating distribution into total body water.
Bioavailability	Oral bioavailability is approximately 95% (absolute). Food does not affect bioavailability but may delay Tmax by 1-2 hours.
Onset of Action	Oral: Improvement in ADHD symptoms may be observed within 1 week of starting therapy, with full effect typically seen by 4-6 weeks.
Duration of Action	Duration of action is approximately 24 hours with once-daily oral administration, consistent with clinical efficacy throughout the day.

Classification & Brands

Dosing & administration

Initial: 0.5 mg orally once daily. Titrate by 0.5 mg increments every 2-3 days based on efficacy and tolerability to a maximum dose of 4 mg once daily. Target dose 2-4 mg once daily.

Dosage form	CAPSULE, EXTENDED RELEASE
Renal impairment	No specific dose adjustment recommended for mild-to-moderate renal impairment. Not studied in severe renal impairment (eGFR <30 mL/min/m2); use with caution.
Liver impairment	Child-Pugh Class A: No adjustment. Child-Pugh Class B: Reduce dose by 50%; maximum dose 2 mg once daily. Child-Pugh Class C: Not recommended.
Pediatric use	Approved for children ≥6 years. Starting dose 0.2 mg (or 0.6 mg if patient is switching from another methylphenidate-based product) orally once daily. Titrate by 0.2 mg increments weekly; maximum 4 mg/day for patients 6-17 years.
Geriatric use	Limited data. No specific dosage adjustment provided; initiate at low end of dosing range (0.5 mg once daily) and titrate cautiously due to potential for increased sensitivity.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for QELBREE (QELBREE).

Breastfeeding	No data on presence in human milk, effects on breastfed infant, or milk production. M/P ratio unknown. Caution advised; consider benefits of breastfeeding, risk of infant drug exposure, and maternal need.
Teratogenic Risk	Limited human data; animal studies show no evidence of teratogenicity at clinically relevant doses. Risk cannot be excluded; use only if potential benefit justifies potential risk.
Fetal Monitoring