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Viagra for Women: How Does It Work, and Is It Safe?

The U.S. Food and Drug Administration (FDA) has recently approved a Viagra-like drug, flibanserin (Addyi), for treatment of female sexual interest/arousal disorder (FSIAD) in premenopausal women.

Currently, Addyi is only available through certain prescribers and pharmacies. It’s prescribed by approved providers in agreement between the manufacturer and the FDA. A prescriber must be certified by the manufacturer to meet certain FDA requirements.

The FDA hasn’t approved Viagra itself for women to use. But it has been prescribed off-label for women with a low sex drive. Evidence of its effectiveness is mixed at best.

A review of trials of Viagra in women speculates that positive results are observed in regard to physical arousal. However, this is not the case for the more complex nature of FSIAD.

For example, the review detailed a study that gave Viagra to 202 postmenopausal women with primary FSIAD. Researchers observed an increased amount of arousal sensations, vaginal lubrication, and orgasm in study participants. However, women with secondary FSIAD-associated disorders reported no increase in desire or enjoyment.

A second study discussed in the review found that both pre- and postmenopausal women reported no significant positive responses when using Viagra.

There are several reasons that women would seek out a Viagra-like pill. As they approach middle age and beyond, it’s not uncommon for women to observe a decrease in their overall sex drive.

A decrease in sex drive can also originate from daily stressors, significant life events, or chronic conditions such as multiple sclerosis or diabetes.

However, some women observe a decrease or absence in sex drive due to a condition called female sexual interest/arousal disorder. FSIAD has also been referred to as hypoactive sexual desire disorder (HSDD). According to one expert panel and review, FSIAD is estimated to affect about 10 percent of adult women. It’s characterized by the following symptoms:

  • limited or absent sexual thoughts or fantasies
  • reduced or absent response of desire to sexual cues or stimulation
  • loss of interest or inability to maintain interest in sexual activities
  • significant feelings of frustration, incompetence, or worry at the lack of sexual interest or arousal

Flibanserin was originally developed as an antidepressant, but was approved by the FDA for treatment of FSIAD in 2015. Its mode of action as far as it relates to FSIAD isn’t well understood. It’s known that taking flibanserin regularly raises levels of dopamine and norepinephrine in the body. At the same time, it lowers levels of serotonin.

Both dopamine and norepinephrine are important for sexual excitement. Dopamine has a role in boosting sexual desire. Norepinephrine has a role in promoting sexual arousal.

The FDA approval of flibanserin was based off of the results of three phase III clinical trials. Each trial lasted 24 weeks and evaluated the efficacy of flibanserin compared to placebo in premenopausal women.

The investigators and the FDA analyzed the results of the three trials. When adjusted for placebo response, it was found that about 10 percent of participants reported a “much improved” or “very much improved” status in trial weeks 8 to 24.

This is a modest improvement when compared to Viagra. A review published three years after the FDA approval of Viagra for treating erectile dysfunction summarizes the worldwide responses to treatment. In the United States, for example, 74 percent of participants responded positively. This is compared to a 19 percent positive response for those taking a placebo.

Flibanserin isn’t FDA-approved for use in postmenopausal women. However, the efficacy of flibanserin in this population was assessed in a single trial. The results were reported as similar to those reported in premenopausal women. This will need to be replicated in additional trials for it to be approved for postmenopausal women.

The most common side effects of flibanserin include:

  • dizziness
  • difficulty falling asleep or remaining asleep
  • nausea
  • dry mouth
  • tiredness
  • hypotension, or low blood pressure
  • fainting or loss of consciousness

You shouldn’t take flibanserin if you drink alcohol or have liver problems. Talk to your doctor about what medications and supplements you’re taking before beginning flibanserin. You shouldn’t take flibanserin if you’re taking any of the following medications or supplements:

  • certain medications used to treat cardiovascular conditions, such as diltiazem (Cardizem) and verapamil (Verelan)
  • certain antibiotics, such as ciprofloxacin (Cipro) and erythromycin (Ery-Tab)
  • medications to treat fungal infections, such as fluconazole (Diflucan) and itraconazole (Sporanox)
  • HIV-1 medications, such as ritonavir (Norvir) and amprenavir (Agenerase)
  • hepatitis C medications, such as boceprevir (Victrelis) and telaprevir (Incivek)
  • nefazodone (Serzone), an antidepressant
  • supplements such as St. John’s Wort, ginkgo, or resveratrol

Lastly, you shouldn’t drink grapefruit juice while taking flibanserin.

The path to FDA approval was challenging for flibanserin. The FDA reviewed the drug three times before approving it. There were concerns about its efficacy when compared with negative side effects. These concerns were the main reasons why the FDA recommended against approval after the first two reviews.

There were also lingering questions regarding how female sexual dysfunction should be treated. Sex drive is quite complex: There’s both a physical and a psychological component.

Flibanserin and Viagra work in different ways. Viagra, for example, doesn’t increase sexual arousal in men. Conversely, flibanserin works to raise levels of dopamine and norepinephrine to promote desire and arousal. Thus, one pill targets a physical aspect of sexual dysfunction. The other targets the feelings of arousal and desire, a more complicated issue.

Following a third review, the FDA approved the drug due to unmet medical needs. However, concerns still remained regarding side effects. A particular concern is severe hypotension observed when flibanserin is taken with alcohol.

There are several key takeaways to consider:

  • There are many causes of low sex drive. Causes range from everyday stressors to female sexual interest/arousal disorder (FSIAD).
  • Evidence of the efficacy of Viagra for low sex drive in women is mixed. There have been positive results regarding physical arousal, but in women with FSIAD, there was no increase in desire.
  • Flibanserin (Addyi) was approved by the FDA in 2015 for treatment of FSIAD in premenopausal women. Clinical trials have reported an overall modest improvement in desire and arousal.
  • Flibanserin is only available from certain approved prescribers and pharmacies.
  • Severe hypotension can occur when taking flibanserin with alcohol or certain medications. Always discuss what medications or supplements you’re taking with your doctor before using flibanserin.