6.2. Benefits versus adverse effects

Due to its unique mechanism of action, vilazodone has the potential benefits of faster onset of action, greater efficacy, and lower adverse event risks compared with currently used antidepressants, especially lower sexual side effects [84, 85]. Preclinical studies and clinical trials showed that vilazodone exhibits a diminished incidence of sexual adverse effects and minimal weight gain, similar for vilazodone and placebo, important aspects given that patients find sexual dysfunction, weight gain, and drowsiness to be the most frequently unpleasant adverse effects induced by antidepressants [86].

Sexual dysfunction was reported in 40–70% of SSRI-treated patients [87], and SSRIs therapy can determine sexual dysfunction in all three phases of the human sexual response cycle


Thus, vilazodone could be beneficial for some subgroups of patients, like ones with depression and comorbid anxiety, and patients with sexual side effects on SSRIs or other antidepressant

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The results of the research published so far have shown that vilazodone has a relatively high level of safety and tolerability in adults. The most frequent adverse effects, which were related to the sleep quality and gastrointestinal tract, were transient in nature and mild to moderate in

The adverse events occurred within the first few weeks of the therapy and led to few premature discontinuations [84, 89]. Further studies are needed not only to evaluate the efficacy and tolerability profile of vilazodone in the elderly and in adolescents with MDD but also to estimate its long-term safety. Due to the lack of information in human trials, it may be administered in

Yet some results require further research on larger groups of subjects, with different characteristics, and for longer periods of time. Yan Li et al. developed a preclinical study and registered that vilazodone diminished depression-like behavior without altering visuospatial memory after 1 month of therapy. But after 3 months of treatment, vilazodone did not alter depressionlike behavior or cognition. The drug was administered in therapeutic doses in healthy middleaged female mice, which were assessed in the forced swim test (for depression-like behavior), in novel object recognition test (for recognition memory), or in novel object placement test (for visuospatial memory). The findings support the age difference in drug response for some

Vortioxetine, 1-[2-(2,4-dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide [91], is another new multimodal antidepressant drug that has been approved for MDD therapy in adult patients, in September 2013 in the United States, in December 2013 in European Union, and later in Canada,

Besides its antidepressant properties proven in several short-and long-term studies [93], vortioxetine demonstrated pro-cognitive effects in preclinical studies, affecting learning and memory processes (enhancing hippocampal synaptic plasticity and augmenting the output of

pregnant women and lactation only if the benefits outweigh the potential risks [83–85].

drugs [85].

severity (Table 7) [80, 81, 85].

System and organ Manifestations

Others Fatigue

Gastrointestinal Nausea, vomiting, diarrhea, dry mouth

Nervous system Dizziness, headache, insomnia

Table 7. The most frequent adverse effects of vilazodone [81, 89].

antidepressant drugs [90].

South Africa, Australia, Mexico, and South Korea [80].

7. Vortioxetine

Table 6. Pharmacological aspects of vilazodone [19, 78, 83].

(desire, arousal, and orgasm). SSRI-induced sexual side effects cannot only reduce patients' quality of life but also cause treatment noncompliance and discontinuation, therefore augmenting the risk of MDD relapse and recurrence [88].

The effects of vilazodone (20 or 40 mg/day) on sexual functioning were also evaluated in healthy, sexually active adults assessed using the Changes in Sexual Functioning Questionnaire (CSFQ a self-report questionnaire with 14 items used in antidepressant trials); vilazodone proved no significant effect on sexual functioning in healthy adults [87].

In a rat sexual behavior model, acute, sub-chronic, and chronic vilazodone treatment did not cause sexual dysfunction; moreover, 1 week vilazodone administration normalized sexual function in animals which registered paroxetine-induced sexual dysfunction [88].

Another benefit of this drug is related to its effect on anxiety disorder, and studies are being conducted to assess its efficacy in generalized anxiety disorder, post-traumatic stress syndrome, and social anxiety illness [80]. As Khan et al. reported, 8-week vilazodone therapy has led to improvements in four psychic anxiety items (anxious mood, depressed mood, tension, intellectual) and five somatic anxiety items (somatic muscular, somatic sensory, respiratory, cardiovascular, and autonomic symptoms) [82].


Table 7. The most frequent adverse effects of vilazodone [81, 89].

Thus, vilazodone could be beneficial for some subgroups of patients, like ones with depression and comorbid anxiety, and patients with sexual side effects on SSRIs or other antidepressant drugs [85].

The results of the research published so far have shown that vilazodone has a relatively high level of safety and tolerability in adults. The most frequent adverse effects, which were related to the sleep quality and gastrointestinal tract, were transient in nature and mild to moderate in severity (Table 7) [80, 81, 85].

The adverse events occurred within the first few weeks of the therapy and led to few premature discontinuations [84, 89]. Further studies are needed not only to evaluate the efficacy and tolerability profile of vilazodone in the elderly and in adolescents with MDD but also to estimate its long-term safety. Due to the lack of information in human trials, it may be administered in pregnant women and lactation only if the benefits outweigh the potential risks [83–85].

Yet some results require further research on larger groups of subjects, with different characteristics, and for longer periods of time. Yan Li et al. developed a preclinical study and registered that vilazodone diminished depression-like behavior without altering visuospatial memory after 1 month of therapy. But after 3 months of treatment, vilazodone did not alter depressionlike behavior or cognition. The drug was administered in therapeutic doses in healthy middleaged female mice, which were assessed in the forced swim test (for depression-like behavior), in novel object recognition test (for recognition memory), or in novel object placement test (for visuospatial memory). The findings support the age difference in drug response for some antidepressant drugs [90].
