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Vilazodone
Antidepressant medication From Wikipedia, the free encyclopedia
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Vilazodone, sold under the brand name Viibryd among others, is a medication used to treat major depressive disorder.[1] It is classified as a serotonin modulator[1] and is taken by mouth.[1]
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Common side effects include nausea, diarrhea, and trouble sleeping.[1] Serious side effects may include increased suicidal thoughts or actions in those under the age of 25, serotonin syndrome, bleeding, mania, pancreatitis, and syndrome of inappropriate antidiuretic hormone secretion (SIADH).[1] Vilazodone may cause less emotional blunting than typical selective serotonin reuptake inhibitors (SSRIs) and serotonin–norepinephrine reuptake inhibitors (SNRIs).[6] A withdrawal syndrome may occur if the dose is rapidly decreased.[1] Use during pregnancy and breastfeeding is not generally recommended.[7] It is in the serotonin modulator class of medications and is believed to work both as an SSRI and activator of the 5-HT1A receptor.[1]
Vilazodone was approved for medical use in the United States in 2011[1] and in Canada in 2018.[8] In 2019, it was the 334th most commonly prescribed medication in the United States, with more than 900 thousand prescriptions.[9] The drug lost patent protection in June 2022 for adults and in July 2023 for pediatrics.[10] Generic versions have been approved by the US Food and Drug Administration.[11][12]
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Medical uses
Seven controlled efficacy trials were conducted of vilazodone for treatment of major depressive disorder.[13] Five of these trials showed no significant influence of vilazodone over placebo on depressive symptoms.[13] In the remaining two trials, small but significant advantages of vilazodone over placebo were found.[13] According to these two eight-week trials in adults, vilazodone has an antidepressant response after one week of treatment.[14] After eight weeks it resulted in a 13% greater response than placebo.[14] Remission rates, however, were not significantly different versus placebo.[14]
According to the US Food and Drug Administration in 2011, "it is unknown whether vilazodone has any advantages compared to other drugs in the antidepressant class."[15] A 2019 review stated that "present studies do not suggest the superiority of vilazodone compared with other antidepressants."[16]
Development of vilazodone for generalized anxiety disorder has been stopped as of 2017.[17] While there is tentative evidence of a small benefit in generalized anxiety disorder, there is a high rate of side effects.[18]
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Adverse effects
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In September 2016, the US Food and Drug Administration required a new warning to be added to the prescription label related to a link between vilazodone and acute pancreatitis and sleep paralysis.[19]
The most common adverse effects include nausea, diarrhea, vomiting, and insomnia.[5]
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.[20][14] In randomized controlled trials, meanwhile, these rates were 28%, 23.4% and 13.3%, respectively.[14] In contrast to other selective serotonin reuptake inhibitors (SSRIs), initial trials showed that vilazodone did not cause decreased sexual desire/function, which often cause people to abandon their use.[21][unreliable medical source?] Additionally, vilazodone may cause less emotional blunting than typical SSRIs and serotonin–norepinephrine reuptake inhibitors (SNRIs).[6]
Pregnancy
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).[22][23] It is uncertain whether there is an increased rate of septal heart defects among children whose mothers were prescribed an SSRI in early pregnancy.[24][25]
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Pharmacology
Pharmacodynamics
Vilazodone acts as a serotonin reuptake inhibitor (IC50 = 2.1 nM; Ki = 0.1 nM) and 5-HT1A receptor partial agonist (IC50 = 0.2 nM; IA = ~60–70%).[14][26] It has negligible affinity for other serotonin receptors such as 5-HT1D, 5-HT2A, and 5-HT2C,[26][27] as well as the norepinephrine and dopamine transporters (Ki = 56 nM for NET and 37 nM for DAT).[5] A small clinical study found occupancy of the 5-HT1A receptor with vilazodone, whereas occupancy of the SERT by vilazodone in humans does not seem to have been studied.[28][29][30]
Pharmacokinetics
Vilazodone is best absorbed with food and has a bioavailability of 72% under fed conditions. The Cmax increased between 147 and 160% and the AUC increased between 64 and 85% of vilazodone when it was administered with either a fatty or light meal.[31]
History
It was developed by Merck KGaA and licensed by Clinical Data, a biotech company purchased by Forest Laboratories in 2011.[32]
References
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