VILOXAZINE

brands

Class

• Neuroscience-based Nomenclature: norepinephrine reuptake inhibitor (N-RI)
• Selective norepinephrine reuptake inhibitor (NRI)

VILOXAZINE commonly prescribed for

(Bold for FDA approved)

How VILOXAZINE works

• Boosts neurotransmitter norepinephrine and may also increase dopamine in prefrontal cortex

• Blocks norepinephrine reuptake pumps, also known as norepinephrine transporters

• Presumably this increases noradrenergic neurotransmission

• Since dopamine is inactivated by norepinephrine reuptake in frontal cortex, which largely lacks dopamine transporters, viloxazine can also increase dopamine neurotransmission in this part of the brain

• Has antagonist actions at serotonin 2B receptors and agonist actions at serotonin 2C receptors and has been shown to increase serotonin levels

How long until VILOXAZINE works

• Onset of therapeutic actions in ADHD can be seen as early as the first week of dosing

• Therapeutic actions may continue to improve for 8–12 weeks; early response after 2 weeks of treatment may predict efficacy outcomes at week 6

Notable Side Effects

• Fatigue, sleepiness, insomnia, irritability, headache

• Decreased appetite, nausea, vomiting, dry mouth, constipation

• Increased heart rate

• Increased blood pressure

Life Threatening Side Effects

• Hypomania and, theoretically, rare induction of mania

• Rare activation of suicidal ideation and behavior (suicidality)

weight gain

unusual

sedation

not usual

What to do about VILOXAZINE side effects

• Wait

• Wait

• Wait

• Mild side effects are common, happen early, and usually improve with time, but treatment benefits can be delayed, and often begin just as the side effects wear off

• Monitor side effects closely, especially when initiating treatment

• Lower the dose

• If viloxazine is sedating, take at night to reduce daytime drowsiness

usual dosage range

• Ages 6 to 11: 100–400 mg once daily

• Ages 12 to 17: 200–400 mg once daily

• Adults: 200–600 mg once daily

Dosage Forms

• Extended-release capsule 100 mg, 150 mg, 200 mg

long term use

• Long-term data are not available

habit forming

• No

Renal Impairment

• Severe impairment (estimated GFR <30 mL/minute/1.73m2 ): initial dose 100 mg once daily; can increase by 50–100 mg each week; maximum recommended dose 200 mg once daily

• Mild to moderate impairment (estimated GFR 30–89 mL/minute/1.73m2 ): dose adjustment not necessary

Hepatic Impairment

• Not recommended

Cardiac Impairment

• Use with caution because viloxazine can increase heart rate and blood pressure

Elderly

• Some patients may tolerate lower doses better

• Reduction in the risk of suicidality with antidepressants compared to placebo in adults age 65 and older

Children and Adolescents

• Approved to treat ADHD in children ages 6 and older

• Carefully weigh the risks and benefits of pharmacological treatment against the risks and benefits of nontreatment and make sure to document this in the patient’s chart

• Monitor patients face-to-face regularly, particularly during the first several weeks of treatment

• Use with caution, observing for activation of known or unknown bipolar disorder and/ or suicidal ideation, and inform parents or guardians of this risk so they can help observe child or adolescent patients

Pregnancy

• Controlled studies have not been conducted in pregnant women

• In rats, administration of viloxazine during organogenesis did not result in significant maternal toxicity but did cause fetal toxicities and delayed fetal development at doses 2 times the maximum recommended human dose (MRHD)

• In rabbits, administration of viloxazine during organogenesis caused maternal toxicity without significant fetal toxicity at doses ≥7 times the MRHD

• The no observed adverse effect levels (NOAELs) for fetal toxicity are approximately equal to 11 times the MRHD, based on mg/m2 in the rat and rabbit

• In rats and mice, administration of viloxazine during pregnancy and lactation caused maternal toxicities and deaths at doses approximately 2 and 1 times the MRHD, based on mg/m2 , respectively; at these maternally toxic doses, viloxazine caused offspring toxicities

• The NOAEL for maternal and developmental toxicity is approximately equal to or less than the MRHD, based on mg/m2 , in the rat and mouse, respectively

• Use in women of childbearing potential requires weighing potential risks and benefits to the mother against potential risks to the fetus

• For women of childbearing potential, viloxazine should generally be discontinued before anticipated pregnancies

• National Pregnancy Registry for Psychiatric Medications: 1–866–961–2388 or http://womensmentalhealth.org/clinical-andresearch-programs/pregnancyregistry/

Breast Feeding

• Unknown if viloxazine is secreted in human breast milk, but all psychotropics are assumed to be secreted in breast milk

• Recommend either to discontinue drug or formula feed