Viibryd (vilazodone HCl)

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Vilazodone hydrochloride is commercially available as immediate-release tablets, which are administered orally once daily and should be taken with food. The manufacturer cautions that taking the drug without food may result in inadequate drug concentrations and reduced efficacy. (See Description.)

Patients receiving vilazodone should be monitored for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustment. (See Worsening of Depression and Suicidality Risk under Warnings/Precautions: Warnings, in Cautions.)

The manufacturer states that at least 2 weeks must elapse between discontinuance of a monoamine oxidase (MAO) inhibitor and initiation of vilazodone therapy and vice versa. (See Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions under Warnings/Precautions: Other Warnings and Precautions, in Cautions and also see Drug Interactions: Monoamine Oxidase Inhibitors.)

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Concurrent or recent (i.e., within 2 weeks) therapy with a monoamine oxidase (MAO) inhibitor. At least 14 days should elapse between discontinuance of vilazodone and initiation of MAO inhibitor therapy and vice versa. (See Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions under Warnings/Precautions: Other Warnings and Precautions, in Cautions and also see Drug Interactions: Monoamine Oxidase Inhibitors.)

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects reported in 5% or more of patients with major depressive disorder receiving vilazodone in clinical studies and at an incidence of at least twice that reported with placebo include diarrhea, nausea, vomiting, and insomnia.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and effectiveness of vilazodone in pediatric patients have not been established.

FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during the first few months of antidepressant treatment compared with placebo in children and adolescents with major depressive disorder, obsessive-compulsive disorder (OCD), or other psychiatric disorders based on pooled analyses of 24 short-term, placebo-controlled trials of 9 antidepressant drugs (SSRIs and other antidepressants). However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs and other antidepressants) in patients younger than 19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or ideation. No suicides occurred in these pediatric trials. These findings should be carefully considered when assessing potential benefits and risks of vilazodone in a child or adolescent for any clinical use. (See Worsening of Depression and Suicidality Risk under Warnings/Precautions: Warnings, in Cautions.)

The manufacturer states that vilazodone is not approved for use in pediatric patients.

Category C. (See Users Guide.)

Some neonates exposed to serotonergic antidepressants (e.g., SSRIs, SNRIs) late in the third trimester of pregnancy have developed complications that have sometimes been severe and required prolonged hospitalization, respiratory support, enteral nutrition, and other forms of supportive care in special-care nurseries. Such complications may arise immediately upon delivery and usually last several days or up to 2-4 weeks. Clinical findings reported to date in the neonates have included respiratory distress, cyanosis, apnea, seizures, temperature instability or fever, feeding difficulty, dehydration, excessive weight loss, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features appear to be consistent with either a direct toxic effect of serotonergic antidepressants or, possibly, a drug withdrawal syndrome. In some cases, the clinical picture was consistent with serotonin syndrome.

Infants exposed to SSRIs in late pregnancy may have an increased risk of persistent pulmonary hypertension of the newborn (PPHN), a rare heart and lung condition associated with substantial neonatal morbidity and mortality. Although several epidemiologic studies have suggested an increased risk of PPHN with SSRI use during pregnancy, other studies did not demonstrate a statistically significant association. The FDA states that it is currently unclear whether the use of SSRIs, including vilazodone, during pregnancy can cause PPHN and recommends that clinicians not alter their current clinical practice of treating depression during pregnancy.

For additional information on the management of depression in women prior to conception and during pregnancy, including treatment algorithms, clinicians may consult the joint American Psychiatric Association and American College of Obstetricians and Gynecologists guidelines (at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3103063/pdf/nihms293836.pdf).

The effect of vilazodone on labor and delivery is unknown. The manufacturer states that the drug should be used during labor and delivery only if the potential benefit to the mother outweighs the potential risk to the infant.

Vilazodone is distributed into milk in rats. It is not known whether the drug is distributed into human milk. The manufacturer states that breast-feeding in vilazodone-treated patients should only be considered if the potential benefit to the mother outweighs the potential risk to the infant.

In clinical trials with vilazodone, 1.7% of patients were 65 years of age or older and 12.5% were 55-64 years of age. Results from a single-dose pharmacokinetic study have shown that the pharmacokinetics of vilazodone are generally similar between geriatric and younger adults. The manufacturer states that dosage adjustment is not necessary based on age. However, increased sensitivity to the drug in some older individuals cannot be ruled out.

Serotonergic antidepressants (e.g., SSRIs, SNRIs) have been associated with clinically important hyponatremia in geriatric patients, who may be at greater risk for this adverse effect. (See Hyponatremia/Syndrome of Inappropriate Antidiuretic Hormone Secretion under Warnings/Precautions: Other Warnings and Precautions, in Cautions.)

In pooled data analyses, a reduced risk of suicidality was observed in adults 65 years of age or older with antidepressant therapy compared with placebo. (See Worsening of Depression and Suicidality Risk under Warnings/Precautions: Warnings, in Cautions.)