vilazodone

Seven controlled efficacy trials were conducted of vilazodone for treatment of major depressive disorder.{{cite journal | vauthors = Kirsch I | title = Antidepressants and the Placebo Effect | journal = Zeitschrift für Psychologie | volume = 222 | issue = 3 | pages = 128–134 | date = 2014 | pmid = 25279271 | pmc = 4172306 | doi = 10.1027/2151-2604/a000176 }} Five of these trials showed no significant influence of vilazodone over placebo on depressive symptoms. In the remaining two trials, small but significant advantages of vilazodone over placebo were found. According to these 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.{{cite journal | vauthors = Wang SM, Han C, Lee SJ, Patkar AA, Masand PS, Pae CU | title = A review of current evidence for vilazodone in major depressive disorder | journal = International Journal of Psychiatry in Clinical Practice | volume = 17 | issue = 3 | pages = 160–169 | date = August 2013 | pmid = 23578403 | doi = 10.3109/13651501.2013.794245 | s2cid = 10702028 }}

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."{{cite journal | vauthors = Laughren TP, Gobburu J, Temple RJ, Unger EF, Bhattaram A, Dinh PV, Fossom L, Hung HM, Klimek V, Lee JE, Levin RL, Lindberg CY, Mathis M, Rosloff BN, Wang SJ, Wang Y, Yang P, Yu B, Zhang H, Zhang L, Zineh I | title = Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant | journal = The Journal of Clinical Psychiatry | volume = 72 | issue = 9 | pages = 1166–1173 | date = September 2011 | pmid = 21951984 | doi = 10.4088/JCP.11r06984 }} A 2019 review stated that "present studies do not suggest the superiority of vilazodone compared with other antidepressants."{{cite journal | vauthors = Stuivenga M, Giltay EJ, Cools O, Roosens L, Neels H, Sabbe B | title = Evaluation of vilazodone for the treatment of depressive and anxiety disorders | journal = Expert Opinion on Pharmacotherapy | volume = 20 | issue = 3 | pages = 251–260 | date = February 2019 | pmid = 30475091 | doi = 10.1080/14656566.2018.1549542 | publisher = Informa UK Limited | hdl = 1887/3630582 | s2cid = 53773793 | hdl-access = free }}

Development of vilazodone for generalized anxiety disorder has been stopped as of 2017.{{cite web |title=New Medicines Newsletter |url=https://www.sps.nhs.uk/wp-content/uploads/2018/01/New-Medicines-Newsletter-December-2017.pdf |website=NHS |access-date=March 21, 2019 |archive-date=March 21, 2019 |archive-url=https://web.archive.org/web/20190321102419/https://www.sps.nhs.uk/wp-content/uploads/2018/01/New-Medicines-Newsletter-December-2017.pdf |url-status=dead }} While there is tentative evidence of a small benefit in generalized anxiety disorder, there is a high rate of side effects.{{cite journal | vauthors = Zareifopoulos N, Dylja I | title = Efficacy and tolerability of vilazodone for the acute treatment of generalized anxiety disorder: A meta-analysis | journal = Asian Journal of Psychiatry | volume = 26 | pages = 115–122 | date = April 2017 | pmid = 28483071 | doi = 10.1016/j.ajp.2017.01.016 }}

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.{{cite web |url= https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022567Orig1s019ltr.pdf |archive-url= https://web.archive.org/web/20170218034017/http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022567Orig1s019ltr.pdf |url-status= dead |archive-date= February 18, 2017 |title=SUPPLEMENT APPROVAL |publisher=U.S. Food and Drug Administration (FDA) }}

The most common adverse effects include nausea, diarrhea, vomiting, and insomnia.

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.{{cite journal | vauthors = Robinson DS, Kajdasz DK, Gallipoli S, Whalen H, Wamil A, Reed CR | title = A 1-year, open-label study assessing the safety and tolerability of vilazodone in patients with major depressive disorder | journal = Journal of Clinical Psychopharmacology | volume = 31 | issue = 5 | pages = 643–6 | date = October 2011 | pmid = 21869687 | doi = 10.1097/JCP.0b013e31822c6741 }} In randomized controlled trials, meanwhile, these rates were 28%, 23.4% and 13.3%, respectively. 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.{{cite news | url=https://www.reuters.com/article/idUSN2111362920110122 | work=Reuters | title=FDA approves Clinical Data Inc's antidepressant | date=January 22, 2011 | url-status=live | archive-url=https://web.archive.org/web/20110127072759/http://www.reuters.com/article/idUSN2111362920110122 | archive-date=January 27, 2011 }}{{Unreliable medical source|date=April 2024}} Additionally, vilazodone may cause less emotional blunting than typical SSRIs and serotonin–norepinephrine reuptake inhibitors (SNRIs).

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).{{cite journal | vauthors = Ross LE, Grigoriadis S, Mamisashvili L, Vonderporten EH, Roerecke M, Rehm J, Dennis CL, Koren G, Steiner M, Mousmanis P, Cheung A | title = Selected pregnancy and delivery outcomes after exposure to antidepressant medication: a systematic review and meta-analysis | journal = JAMA Psychiatry | volume = 70 | issue = 4 | pages = 436–443 | date = April 2013 | pmid = 23446732 | doi = 10.1001/jamapsychiatry.2013.684 | doi-access = free }}{{cite journal | vauthors = Lattimore KA, Donn SM, Kaciroti N, Kemper AR, Neal CR, Vazquez DM | title = Selective serotonin reuptake inhibitor (SSRI) use during pregnancy and effects on the fetus and newborn: a meta-analysis | journal = Journal of Perinatology | volume = 25 | issue = 9 | pages = 595–604 | date = September 2005 | pmid = 16015372 | doi = 10.1038/sj.jp.7211352 | doi-access = free }} It is uncertain whether there is an increased rate of septal heart defects among children whose mothers were prescribed an SSRI in early pregnancy.{{cite journal | vauthors = Pedersen LH, Henriksen TB, Vestergaard M, Olsen J, Bech BH | title = Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study | journal = BMJ | volume = 339 | issue = sep23 1 | pages = b3569 | date = September 2009 | pmid = 19776103 | pmc = 2749925 | doi = 10.1136/bmj.b3569 }}{{cite journal | vauthors = Huybrechts KF, Palmsten K, Avorn J, Cohen LS, Holmes LB, Franklin JM, Mogun H, Levin R, Kowal M, Setoguchi S, Hernández-Díaz S | title = Antidepressant use in pregnancy and the risk of cardiac defects | journal = The New England Journal of Medicine | volume = 370 | issue = 25 | pages = 2397–2407 | date = June 2014 | pmid = 24941178 | pmc = 4062924 | doi = 10.1056/NEJMoa1312828 }}

Vilazodone acts as a serotonin reuptake inhibitor (IC₅₀ = 2.1 nM; K_i = 0.1 nM) and 5-HT_1A receptor partial agonist (IC₅₀ = 0.2 nM; IA = ~60–70%).{{cite journal | vauthors = Hughes ZA, Starr KR, Langmead CJ, Hill M, Bartoszyk GD, Hagan JJ, Middlemiss DN, Dawson LA | title = Neurochemical evaluation of the novel 5-HT1A receptor partial agonist/serotonin reuptake inhibitor, vilazodone | journal = European Journal of Pharmacology | volume = 510 | issue = 1–2 | pages = 49–57 | date = March 2005 | pmid = 15740724 | doi = 10.1016/j.ejphar.2005.01.018 }} It has negligible affinity for other serotonin receptors such as 5-HT_1D, 5-HT_2A, and 5-HT_2C,{{cite journal | vauthors = Page ME, Cryan JF, Sullivan A, Dalvi A, Saucy B, Manning DR, Lucki I | title = 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 | journal = The Journal of Pharmacology and Experimental Therapeutics | volume = 302 | issue = 3 | pages = 1220–1227 | date = September 2002 | pmid = 12183683 | doi = 10.1124/jpet.102.034280 | s2cid = 12020750 }} as well as the norepinephrine and dopamine transporters (K_i = 56 nM for NET and 37 nM for DAT). A small clinical study found occupancy of the 5-HT_1A receptor with vilazodone, whereas occupancy of the SERT by vilazodone in humans does not seem to have been studied.{{cite journal | vauthors = Dawson LA | title = The discovery and development of vilazodone for the treatment of depression: a novel antidepressant or simply another SSRI? | journal = Expert Opinion on Drug Discovery | volume = 8 | issue = 12 | pages = 1529–1539 | date = December 2013 | pmid = 24195711 | doi = 10.1517/17460441.2013.855195 | s2cid = 19662281 }}{{cite journal | vauthors = Dawson LA, Watson JM | title = Vilazodone: a 5-HT1A receptor agonist/serotonin transporter inhibitor for the treatment of affective disorders | journal = CNS Neuroscience & Therapeutics | volume = 15 | issue = 2 | pages = 107–117 | date = 2009 | pmid = 19499624 | pmc = 6493994 | doi = 10.1111/j.1755-5949.2008.00067.x }}{{cite journal | vauthors = Choi E, Zmarlicka M, Ehret MJ | title = Vilazodone: a novel antidepressant | journal = American Journal of Health-System Pharmacy | volume = 69 | issue = 18 | pages = 1551–1557 | date = September 2012 | pmid = 22935937 | doi = 10.2146/ajhp110374 }}

Vilazodone is best absorbed with food and has a bioavailability of 72% under fed conditions. The C_max 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.{{cite journal | vauthors = Cruz MP | title = Vilazodone HCl (Viibryd): A Serotonin Partial Agonist and Reuptake Inhibitor For the Treatment of Major Depressive Disorder | journal = P & T | volume = 37 | issue = 1 | pages = 28–31 | date = January 2012 | pmid = 22346333 | pmc = 3278186 }}

It was developed by Merck KGaA and licensed by Clinical Data, a biotech company purchased by Forest Laboratories in 2011.{{cite web|url=http://www.xconomy.com/boston/2015/04/13/blend-therapeutics-taps-former-clinical-data-chief-fromkin-as-new-ceo/|title=Xconomy: Blend Therapeutics Taps Former Clinical Data Chief Fromkin As New CEO|date=April 13, 2015|website=xconomy.com|access-date=May 6, 2018|url-status=live|archive-url=https://web.archive.org/web/20170909234053/http://www.xconomy.com/boston/2015/04/13/blend-therapeutics-taps-former-clinical-data-chief-fromkin-as-new-ceo/|archive-date=September 9, 2017}}

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