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 900thousand 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 U.S. Food and Drug Administration (FDA).[11][12]
Medical uses
Seven controlled efficacy trials were conducted of vilazodone for treatment of major depressive disorder (MDD).[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 (FDA) staff 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 (GAD) has been stopped as of 2017.[17] While there is tentative evidence of a small benefit in GAD, there is a high rate of side effects.[18]
Adverse effects
In September 2016, the FDA wrote a letter to Forest Labs requiring a new warning to be added to the label related to a link between the drug 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 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 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]
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]
^ abcdefWang SM, Han C, Lee SJ, Patkar AA, Masand PS, Pae CU (August 2013). "A review of current evidence for vilazodone in major depressive disorder". International Journal of Psychiatry in Clinical Practice. 17 (3): 160–169. doi:10.3109/13651501.2013.794245. PMID23578403. S2CID10702028.
^Laughren TP, Gobburu J, Temple RJ, Unger EF, Bhattaram A, Dinh PV, et al. (September 2011). "Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant". The Journal of Clinical Psychiatry. 72 (9): 1166–1173. doi:10.4088/JCP.11r06984. PMID21951984.
^Stuivenga M, Giltay EJ, Cools O, Roosens L, Neels H, Sabbe B (February 2019). "Evaluation of vilazodone for the treatment of depressive and anxiety disorders". Expert Opinion on Pharmacotherapy. 20 (3). Informa UK Limited: 251–260. doi:10.1080/14656566.2018.1549542. hdl:1887/3630582. PMID30475091. S2CID53773793.
^Zareifopoulos N, Dylja I (April 2017). "Efficacy and tolerability of vilazodone for the acute treatment of generalized anxiety disorder: A meta-analysis". Asian Journal of Psychiatry. 26: 115–122. doi:10.1016/j.ajp.2017.01.016. PMID28483071.
^Robinson DS, Kajdasz DK, Gallipoli S, Whalen H, Wamil A, Reed CR (October 2011). "A 1-year, open-label study assessing the safety and tolerability of vilazodone in patients with major depressive disorder". Journal of Clinical Psychopharmacology. 31 (5): 643–6. doi:10.1097/JCP.0b013e31822c6741. PMID21869687.
^ abHughes ZA, Starr KR, Langmead CJ, Hill M, Bartoszyk GD, Hagan JJ, et al. (March 2005). "Neurochemical evaluation of the novel 5-HT1A receptor partial agonist/serotonin reuptake inhibitor, vilazodone". European Journal of Pharmacology. 510 (1–2): 49–57. doi:10.1016/j.ejphar.2005.01.018. PMID15740724.
^Page ME, Cryan JF, Sullivan A, Dalvi A, Saucy B, Manning DR, et al. (September 2002). "Behavioral and neurochemical effects of 5-(4-[4-(5-Cyano-3-indolyl)-butyl)-butyl]-1-piperazinyl)-benzofuran-2-carboxamide (EMD 68843): a combined selective inhibitor of serotonin reuptake and 5-hydroxytryptamine(1A) receptor partial agonist". The Journal of Pharmacology and Experimental Therapeutics. 302 (3): 1220–1227. doi:10.1124/jpet.102.034280. PMID12183683. S2CID12020750.
^Dawson LA (December 2013). "The discovery and development of vilazodone for the treatment of depression: a novel antidepressant or simply another SSRI?". Expert Opinion on Drug Discovery. 8 (12): 1529–1539. doi:10.1517/17460441.2013.855195. PMID24195711. S2CID19662281.
^Choi E, Zmarlicka M, Ehret MJ (September 2012). "Vilazodone: a novel antidepressant". American Journal of Health-System Pharmacy. 69 (18): 1551–1557. doi:10.2146/ajhp110374. PMID22935937.
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