'Female Viagra' Doesn't Work Very Well: Study

The so-called “female Viagra” drug isn’t showing impressive results, suggests a new study published in JAMA Internal Medicine.

Last August, the U.S. Food and Drug Administration (FDA) approved the drug flibanserin to treat low sexual desire in premenopausal women. The drug was the first to be given the green light for treatment of the condition in women, called hypoactive sexual desire disorder, or HSDD. Researchers in the Netherlands conducted a review on flibanserin to see how safe and effective it was, analyzing eight clinical trials in all: five published and three unpublished. Even though the studies in total looked at almost 6,000 women, the researchers caution that the quality of evidence is “very low”: the studies weren’t very detailed, they write, and the drug looked better in the findings of published studies compared to studies that were not published.

MORE: See How ‘Female Viagra’ Works

According to the results, the drug didn’t enhance most women’s sex life all that much, nor did it meaningfully increase the frequency of their sexual encounters. Taking the drug was associated with just one-half of an additional satisfying sexual event each month. It was also linked to a higher risk of sleepiness, dizziness, fatigue and nausea.

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Valeant Pharmaceuticals, which manufactures flibanserin under the name Addyi, provided a statement from the company’s Chief Medical Officer Tage Ramakrishna, MD, saying that trials to secure FDA approval showed a statistically significant increase in satisfying sex. “It is crucial that women suffering from HSDD are able to speak to their physicians about the full range of options—including medical treatment—to manage this serious and well-established condition,” Ramakrishna says. “Analyses such as the one published in JAMA Internal Medicine, by omitting context and downplaying the importance of increased sexually satisfying events to those with HSDD, makes that conversation more difficult.”

More research is needed, the authors of the study say. “The data presented in this review suggest that the meaningful change caused by flibanserin is minimal,” they write.

Write to Mandy Oaklander at mandy.oaklander@time.com.