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STEPS New Drug Reviews

Vilazodone (Viibryd) for the Treatment of Depression JOHN D. GAZEWOOD, MD, MSPH; PARKER SLAYTON, MD; and KATHERINE DeGEORGE, MD, MS University of Virginia Health System, Charlottesville, Virginia

STEPS new drug reviews Vilazodone (Viibryd) is a serotonin1A partial and labeled for the cover Safety, Tolerability, treatment of major depressive disorder in adults. Effectiveness, Price, and Simplicity. Each indepen- dent review is provided by authors who have no Cost of one month of financial association with Drug Dosage Dose form treatment* the drug manufacturer. Vilazodone (Viibryd) 10 mg per day, increasing 10-, 20-, and $149 for 30 tablets (prices The series coordinator for over two weeks to 40 mg 40-mg tablets are identical for 10-, 20-, AFP is Allen F. Shaugh- per day and 40-mg tablets) nessy, PharmD, Tufts University Family Medicine *—Estimated retail price of one month’s treatment based on information obtained at http://www.lowestmed.com Residency Program at (accessed July 11, 2013). Cambridge Health Alli- ance, Malden, Mass. A collection of STEPS pub- SAFETY about twice as common as in patients taking lished in AFP is available 2-4 at http://www.aafp.org/ Vilazodone causes few serious adverse effects, placebo. The most common adverse effects afp/steps. although long-term safety has not been estab- are and , although these are lished.1 In a one-year open-label case series, usually transient.2-4 Less commonly, vilazo- 3.8% of patients experienced serious adverse done may cause dizziness, , vomit- effects, including pneumonia, suicidal ide- ing, abnormal dreams, , , ation or behavior, and syndrome.1 tremor, and .2-4 Vilazodone causes As with other , vilazodone sexual dysfunction in about 16% of men and carries a boxed warning for increased risk of 5% of women.2-4 Patients can expect to gain suicidality in patients 24 years and younger.2 about 3.8 lb (1.7 kg) after 12 months.1 Vilazodone is contraindicated in patients taking monoamine oxidase inhibitors, and EFFECTIVENESS its use should be avoided with other seroton- Vilazodone has not been studied in patients ergic drugs, including antidepressants, tra- who have mild to moderate major depres- madol (Ultram), and .2 Vilazodone sion. It has been studied in patients with does not cause electrocardiographic changes moderate to severe depression, with inves- or significant abnormal findings on basic tigators looking at clinical remission and laboratory tests.1-4 Strong inhibitors of the treatment response (characterized as a 50% cytochrome P450 3A4 liver enzyme, such as or greater reduction in depression score). , may cause excessive accumula- Among outpatients with moderate to severe tion of vilazodone; therefore, the dosage of depression, vilazodone will induce clinical vilazodone should be reduced to 20 mg per remission in about 25% of patients com- day when used concurrently with these types pared with 18% taking placebo,2-4 with one of medications.2,5 additional patient achieving relief after eight weeks for every 14 patients treated with TOLERABILITY vilazodone compared with placebo (number About one in 14 patients taking vilazodone needed to treat [NNT] = 14; 95% confi- for eight weeks will discontinue the medica- dence interval [CI], 8 to 55).2-4 Similarly, tion because of unwanted effects, which is about 42% of patients who have moderate to

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severe depression will respond to treatment safe for long-term use based on a small study (NNT = 8; 95% CI, 6 to 16).2-4 To date, no of one year’s duration, other antidepressants research has been conducted to determine have much more research supporting their the rate of relapse in patients taking vilazo- long-term safety. done. There are no studies comparing vilazo- Address correspondence to John D. Gazewood, MD, done with other depression treatments. MSPH, at [email protected]. Reprints are not available from the authors. PRICE Author disclosure: No relevant financial affiliations. A one-month supply of vilazodone (40 mg 6 per day) costs approximately $149. In com- REFERENCES parison, a 90-day supply of 1. Robinson DS, Kajdasz DK, Gallipoli S, Whalen H, Wamil A, (50 mg per day) costs approximately $10, and Reed CR. A 1-year, open-label study assessing the safety a 90-day supply of (Zoloft; 100 mg and tolerability of vilazodone in patients with major per day) costs approximately $17.6 depressive disorder. J Clin Psychopharmacol. 2011;31(5): 643-646. SIMPLICITY 2. Citrome L. Vilazodone for major depressive disorder: a systematic review of the efficacy and safety profile for Vilazodone should be taken once daily in the this newly approved - what is the num- morning with food to increase absorption.7 ber needed to treat, number needed to harm and likeli- hood to be helped or harmed? Int J Clin Pract. 2012; The starting dosage is 10 mg per day and is 66(4):356-368. titrated upward over two weeks to a target 3. Khan A, Cutler AJ, Kajdasz DK, et al. A randomized, dou- dosage of 40 mg per day.7 Patients should be ble-blind, placebo-controlled, 8-week study of vilazo- instructed to taper the dosage when discon- done, a agent for the treatment of major depressive disorder. J Clin Psychiatry. 2011;72(4):441-447. 7 tinuing use. 4. Rickels K, Athanasiou M, Robinson DS, Gibertini M, Whalen H, Reed CR. Evidence for efficacy and tol- Bottom Line erability of vilazodone in the treatment of major depressive disorder: a randomized, double-blind, placebo- The available evidence does not support the controlled trial. J Clin Psychiatry. 2009;70(3):326-333. routine use of vilazodone in the treatment of 5. Laughren TP, Gobburu J, Temple RJ, et al. Vilazodone: depression. It is significantly more expensive clinical basis for the US Food and Drug Administration’s than generic alternatives and is no more approval of a new antidepressant. J Clin Psychiatry. 2011; 72(9 ):1166 -1173. effective for moderate to severe depression 6. Lowestmed.com. http://www.lowestmed.com. Accessed than selective serotonin reuptake inhibitors July 11, 2013. 8 or antidepressants. Furthermore, 7. Choi E, Zmarlicka M, Ehret MJ. Vilazodone: a novel anti- vilazodone has not been studied in the treat- depressant. Am J Health Syst Pharm. 2012;69 (18):1551- ment of mild to moderate depression, the 1557. 8. Arroll B, Elley CR, Fishman T, et al. Antidepressants kind most commonly seen by family physi- versus placebo for depression in primary care. Cochrane cians. Although vilazodone appears to be Database Syst Rev. 2009;(3):CD007954. ■

264 American Family Physician www.aafp.org/afp Volume 88, Number 4 ◆ August 15, 2013