Vilazodone was approved for medical use in the United States in 2011. It is not approved in other countries as of 2016. In the United States the wholesale cost for a month of medication is about 261 USD. In 2016 it was the 278th most prescribed medication in the United States with more than a million prescriptions.
According to two eight-week trials in adults, vilazodone has an antidepressant response after one week of treatment. After eight weeks it resulted in a 13% greater response than placebo. Remission rates, however, were not significantly different versus placebo.
According to FDA staff, "it is unknown whether vilazodone has any advantages compared to other drugs in the antidepressant class."
Development for generalized anxiety disorder (GAD) has been stopped as of 2017. While there is tentative evidence of a small benefit in GAD there is a high rate of side effects.
On September 6, 2016, the FDA wrote a letter to Forest Labs requiring a new warnings to be added to the label related to a link between the drug and acute pancreatitis.
After a one-year, open-label study assessing the safety and tolerability of vilazodone in people with major depressive disorder, the most common adverse effects were diarrhea (35.7%), nausea (31.6%), and headache (20.0%); greater than 90% of these adverse effects were mild or moderate. In randomized controlled trials, meanwhile, these rates were 28%, 23.4% and 13.3%, respectively. In contrast to other SSRIs, initial trials showed that vilazodone did not cause decreased sexual desire/function, which often cause people to abandon their use.
Incidence of adverse effects include:
Mania/hypomania—a potentially dangerously elated/agitated mood. Every antidepressant has the potential to induce these psychiatric reactions. They are particularly problematic in those with a history of hypomania/mania such as those with bipolar disorder.
Unknown-incidence adverse effects
Suicidal ideation—all antidepressants can cause suicidal ideation especially in young adults and adolescents under the age of 25.
Abnormal bleeding—the SSRIs are known for their ability to increase the incidence of gastrointestinal bleeds and other bleeding abnormalities.
Antidepressant exposure (including vilazodone) is associated with shorter average duration of pregnancy (by three days), increased risk of preterm delivery (by 55%), lower birth weight (by 75 g), and lower Apgar scores (by <0.4 points). It is uncertain whether there is an increased rate of septal heart defects among children whose mothers were prescribed an SSRI in early pregnancy.
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