In a related editorial, the authors criticise the US Food and Drug Administration (FDA) for approving flibanserin on such weak evidence of efficacy, especially considering the statistically significant increase in clinically significant adverse events that were seen, including a 4-fold increased risk of dizziness, a nearly 4-fold increase in somnolence and a more than 2-fold increased risk of nausea.
Flibanserin was approved by the US FDA in August 2015 for treating hypoactive sexual desire disorder in premenopausal women, a disorder defined as persistent or recurrent deficiency in sexual fantasies and desire for sexual activity, accompanied by marked distress and interpersonal difficulty. The drug is not yet approved for use in Europe.
Flibanserin includes instructions to take the drug at bedtime, and not to engage in activities requiring full alertness, such as driving, until at least 6 hours after taking the drug.