With regards to side effects, the risk ratio for study discontinuation due to adverse events was 2.19 (95% CI, 1.50–3.20). Compared to placebo, the most common adverse events reported for flibanserin 100mg were dizziness (4.00 [95% CI, 2.56–6.27]), somnolence (3.97 [95% CI, 3.01-5.24]), nausea (2.35 [95% CI, 1.85-2.98]), and fatigue (1.64 [95% CI, 1.27-2.13]); overall ratio for most common adverse events was 2.86 (95% CI, 2.32–3.52). For serious adverse events (ie, hypotension, syncope), the risk ratio did not differ between flibanserin and placebo.
On average, treatment with flibaserin resulted in 0.5 additional SSEs per month but also significantly increased the risk of adverse events such as dizziness, somnolence, nausea, and fatigue, which were reported as mild or moderate in intensity. These adverse events, as well as more serious ones such as hypotension and syncope, may also be exacerbated by concurrent alcohol intake and CYP3A4 inhibitors (ie, oral contraceptives, fluconazole), both addressed in the prescribing information for flibanserin. Previous research indicates that nearly 90% of U.S. physicians would prescribe a pharmacological agent for the treatment of HSDD over available nonpharmacological treatments, but the findings of this study show that clinicians should weigh the marginal benefits of flibanserin with the risk of possibly significant side effects.
Given that the study excluded women with a wide range of medication uses, diseases (including psychological disorders), and those not in stable, heterosexual relationships, it is unclear to what extent these findings represent typical women with HSDD. The researchers conclude that “before flibanserin can be recommended in guidelines and clinical practice, future studies should include women from diverse populations, particularly women with (a history of) somatic and psychological comorbidities, medication use, and surgical menopause.”
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