brands

Class

• Neuroscience-based Nomenclature: serotonin multimodal (S-MM)
• SPARI (serotonin partial agonist reuptake inhibitor)
• Dual-acting serotonin reuptake inhibitor plus serotonin 1A partial agonist

VILAZODONE commonly prescribed for

(Bold for FDA approved)

How VILAZODONE works

• Boosts neurotransmitter serotonin

• Blocks serotonin reuptake pump (serotonin transporter)

• Desensitizes serotonin receptors, especially serotonin 1A autoreceptors

• Presumably increases serotonergic neurotransmission

• Partial agonist actions at presynaptic somatodendritic serotonin 1A autoreceptors may theoretically enhance serotonergic activity and contribute to antidepressant actions

• Partial agonist actions at postsynaptic serotonin 1A receptors may theoretically diminish sexual dysfunction caused by serotonin reuptake inhibition

How long until VILAZODONE works

• Onset of therapeutic actions may be sooner than with other SSRIs due to vilazodone’s actions at serotonin 1A receptors, with current data suggesting onset of efficacy as early as week 1, despite the fact that standard titration does not arrive at full therapeutic dose of 40 mg until the third week

• If it is not working within 6 or 8 weeks, it may require a dosage increase (off label) or it may not work at all

• May continue to work for many years to prevent relapse of symptoms

Notable Side Effects

• Nausea, diarrhea, vomiting, dry mouth

• Insomnia, dizziness

• Activation (short-term; patients with diagnosed or undiagnosed bipolar or psychotic disorders may be more vulnerable to CNS-activating actions of SSRIs

• Sexual dysfunction (men: delayed ejaculation; men and women: decreased sexual desire, anorgasmia) slightly greater than placebo and generally less than for SSRIs/SNRIs, but no head-to-head studies

• Bruising and rare bleeding

• Syndrome of inappropriate antidiuretic hormone secretion (SIADH)

Life Threatening Side Effects

• Rare seizures

• Rare hyponatremia (mostly in elderly patients and generally reversible on discontinuation of vilazodone)

• Rare induction of mania and activation of suicidal ideation

weight gain

unusual

sedation

unusual

What to do about VILAZODONE side effects

• Wait

• Wait

• Wait

• In a few weeks, switch to another agent or add other drugs

usual dosage range

• 20–40 mg/day

Dosage Forms

• Tablets 10 mg, 20 mg, 40 mg

long term use

• Has not been evaluated in controlled studies, but long-term treatment of major depressive disorder is generally necessary

habit forming

• No

Renal Impairment

• No dose adjustment necessary

Hepatic Impairment

• No dose adjustment necessary for mild to moderate impairment

• Has not been studied in patients with severe hepatic impairment

Cardiac Impairment

• Not systematically evaluated in patients with cardiac impairment

• Vilazodone has not shown any significant effect on blood pressure, heart rate, or QTc interval in placebo-controlled trials

• Treating depression with SSRIs in patients with acute angina or following myocardial infarction may reduce cardiac events and improve survival as well as mood

Elderly

• No dose adjustment necessary

• Some patients may tolerate lower doses better

• Risk of SIADH with SSRIs is higher in the elderly

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

Children and Adolescents

• Safety and efficacy have not been established

• Use with caution, observing for activation of known or unknown bipolar disorder and/ or suicidal ideation, and strongly consider informing 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

• Not generally recommended for use during pregnancy, especially during first trimester

• Nonetheless, continuous treatment during pregnancy may be necessary and has not been proven to be harmful to the fetus

• At delivery there may be more bleeding in the mother and transient irritability or sedation in the newborn

• Must weigh the risk of treatment (first trimester fetal development, third trimester newborn delivery) to the child against the risk of no treatment (recurrence of depression, maternal health, infant bonding) to the mother and child

• For many patients, this may mean continuing treatment during pregnancy

• Exposure to serotonin reuptake inhibitors early in pregnancy may be associated with increased risk of septal heart defects (absolute risk is small)

• Serotonin reuptake inhibitor use beyond the 20th week of pregnancy may be associated with increased risk of pulmonary hypertension in newborns, although this is not proven

• Exposure to serotonin reuptake inhibitors late in pregnancy may be associated with increased risk of gestational hypertension and preeclampsia

• Neonates exposed to SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding; reported symptoms are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome, and include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying

• National Pregnancy Registry for Antidepressants: 1–844–405–6185

Breast Feeding

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

• Trace amounts may be present in nursing children whose mothers are on vilazodone

• If child becomes irritable or sedated, breast feeding or drug may need to be discontinued

• Immediate postpartum period is a high-risk time for depression, especially in women who have had prior depressive episodes, so drug may need to be reinstituted late in the third trimester or shortly after childbirth to prevent a recurrence during the postpartum period

• Must weigh benefits of breast feeding with risks and benefits of antidepressant treatment versus nontreatment to both the infant and the mother

• For many patients, this may mean continuing treatment during breast feeding