Last month the FDA approved a medication that will reportedly increase the sex drive of premenopausal women. Previous applications for approval by the FDA were denied in 2009 and 2013 because of safety concerns.
Addyi, its brand name (pronounced ADD-eee), will be released next month (Oct. 17). It increases a woman's sex drive by 37%. In the drug trials, women on Addyi experienced one "satisfying sexual event" (SSE) per month more than women taking a placebo. On placebo women had 1.5 more SSE per month from baseline while Addyi users had 2.5 more SSE per month from baseline. These minimal benefits -- one SSE per month more than a placebo -- is the reason specialists and prescribers are concerned about the benefit/risk ratio. But others are saying that this one SSE can make a big difference in a woman's life and her relationship.
They're calling it the "female Viagra," which is a misnomer because unlike Viagra it works in the brain, not the sex organ, and requires continuous daily dosing at nighttime for its therapeutic effect. You take it every night. It is in the same chemical category as an antidepressant. It has the usual side effects of any prescription medication (dizziness, drowsiness, nausea, fatigue, insomnia, dry mouth) with the added and more important side effect of severe low blood pressure, exacerbated by the use of alcohol, causing unpredictable blackouts. Side effects are also aggravated by birth control pills.
According to information at the FDA site, other drugs that increase its side effects are oral contraceptives, Paxil, antifungals (Diflucan). As well as grapefruit juice. Drugs that are decreased in effectiveness by Addyi are digitalis, the cholesterol medicine Simvastatin (Zocor), birth control pills, and Wellbutrin.
Experts are predicting that adverse events will skyrocket after its release due to two factors: 1) the clinical trial group being healthier than the general population, and 2) off-label use and drinking while taking the drug in spite of warnings. Because of its side effect profile prescribers and pharmacists will be required to go through a certification program before being able to prescribe it. A patient-provider agreement form acknowledging these risks will have to be signed.
Some specialists are therefore recommending psychosexual therapy prior to the prescribing of the drug.
It's supposed to cost the same as a "one month supply" of Viagra, whatever that comes to, assuming you have insurance. (Out of pocket, no insurance, one Viagra pill now averages $42). The drug will obviously be more affordable for persons with insurance and who also have a coupon.
But, hopefully, this drug will be a benefit to couples for whom sexual desire is lacking and is also a problem. The company says they number 1 in 10.
Sexuality and its expression in all forms is of course integral to most relationships; its dysfunction can cause a strain. The causes for decreased sex drive are many, varied, and complex. So much so that I'm not so sure a pill will be a fix for many women who qualify.
The first time I heard a woman tell me she couldn't care less if she ever had sex again I just thought she was having a bad day. Didn't think she really meant it, she being in her early forties. But I better understood as time went by as I continued to hear from time to time this same refrain. Then, I figured everyone couldn't be having a "bad day." I still continue to hear this refrain, not often, but from time to time.
And the refrain is not so much a complaint as it is an admission, in some cases a confession of sorts, of their new take on sex and perhaps the new meaning it has for them now at this particular time in their personal lives. It's common knowledge that aging takes a greater toll naturally so on the sex drive of women than it does on men.
Women who develop this indifference to sexual intercourse (not sexual intimacy) are, generally speaking, not all, in stable relationships, unfettered by emotional challenges, and talk maturely and matter-of-factly about it. It's as if they realized that, in resignation to however this new viewpoint developed, that there's much more to life than having to worry about having sexual intercourse a certain number of times a week or month. There are other ways to be intimate. I'm sure there are many who might consider such a woman to be "weird" and "in left field," especially in our sex-soaked, sex-focused culture.
With respect to other ways of being intimate I was reminded of this recently at the wedding of my nephew and his bride when the celebrant, in his homily, counseled the couple, and those listening, that it is intimacy in its many forms that is most important in an enduring relationship -- with the key word being "enduring." Without uttering the word "sex" he said in so many words that while sex is certainly important, if it is the driving force in the relationship, then the relationship will forever be strained and challenged. I think level-headed people agree.
But how many of these women with a decreased libido are also indifferent to having sexual intercourse? For the company's sake I'm sure they're hoping it's small in number. In my practice, as one solo physician, I have and continue to hear its verification to know that it's some amount. I know other doctors have a similar experience.
While many women probably feel as if this indifference is something of an outlier they shouldn't necessarily feel that it is pathological -- unless of course it's causing a problem for them personally or for their relationship. At least this is my humble opinion.