Since flibanserin (Addyi) was approved by the FDA for Hypoactive Sexual Desire Disorder (HSDD), I have been working to understand how to use it in my practice. To be clear, I have no financial ties to the makers of Addyi or any other pharmaceutical company. I run the Midlife and Menopause Health Service for Spectrum Health and MSU College of Human Medicine in West Michigan. I simply need to stay current in order to best serve my patients, students, and referring providers.
I want to know -- will flibanserin be a good addition to my toolbox? Do the benefits offset safety concerns? I am grateful for the introduction of pharmaceutical options for low desire, but only time and clinical experience will inform us whether the risks of this first to market medication outweigh the benefits.
The Patient Encounter
Sexual health issues at the end of a patient visit are what I used to dread. The patient visit is wrapping up, and I ask "Anything else?" The patient responds No, thank you." Then as I would stand to walk out, I'd hear "By the way, why is my sex drive gone?" My heart would sink. I knew this needed a long conversation, but didn't I have time or answers.
Thanks to the International Society for the Study of Women's Sexual Health (ISSWSH), the North American Menopause Society (NAMS), the FDA, and tireless, dedicated researchers, I have become educated, understand treatment options, and now proactively ask patients about their sexual health. I can respond with a diagnostic work up and a therapeutic approach.
Now I no longer wait to pose the question.
HSDD
Over 40% of women have some sexual dysfunction, the most common of which is low desire, which peaks in early menopause. The DSM-5 (2013) merged Female HSDD and Female Arousal Dysfunction into a single diagnostic entity, Female Sexual Interest/Arousal Disorder. But most of the research, including pharmaceutical clinical development and patient surveys, focused on HSDD.
HSDD is known to impact quality of life, interpersonal relationships, and health comorbidities such as depression. A of 450 pre- and post-menopausal women showed that 27% and 34%, respectively, were very distressed by HSDD, and a majority cited its impact on interpersonal relationships, body image, and self confidence.
A vast majority would have liked sex more often but did not recognize HSDD as a treatable medical condition, and had never before mentioned their HSDD to a clinician. Patient surveys confirm that clinicians don't bring it up either. Possible reasons include a lack of training regarding sexual health, lack of a treatment options, and concern for time and compensation.
Armed with a plan, I now regularly add discussion of sexual health to most patients' visits. In 10 minutes, I can capture basic information, validate concerns, formulate a sense of why she has diminished or absent desire, and offer options for improvement.
Approaches to Treatment
Many studies have examined the cause of HSDD. It is not always a problem with the relationship. As Kingsberg teaches, sexual desire is made up of three components: biologic drive, psychosocial issues and beliefs, and motivation and behavior.
The psychosocial component includes prior sexual trauma, anxiety or depression, low self-image and confidence, or issues within the relationship. Motivation and behavior may include fatigue, heart disease, pelvic or vulvar pain, medications, hormonal changes of menopause, vaginal dryness or genitourinary syndrome of menopause (GSM), or lifestyle factors such as exercise and diet. Biologic drive is the component not well understood, and, until recently, had no treatment options.
One way I have gained comfort with diagnosing and treating HSDD is to use the PLISSIT model of sex therapy. This was developed in 1976 by Jack Annon in order to organize a sexual medicine patient encounter and improve patient outcomes.
PLISSIT stands for "Permission to discuss sex, Limited Information on causes of low desire and treatment options, Specific Suggestions for choices for the patient to consider or try, and Intensive Therapy. Treatment." The latter might include vaginal estrogen for GSM, topical non-FDA approved transdermal testosterone therapy, prescriptive flibanserin, or referral to specialists such as pelvic floor physical therapists, sex therapists, or certified menopause specialists (NCMP).
For women who want to want again, there are many options.
Until flibanserin, I had not thought much about the patients for whom it is intended. When I saw such patients with low biologic drive, I thought it was my fault for not figuring it out, or perhaps they were not truly motivated.
I now know differently.
Flibanserin is a molecule that selectively modulates serotonin receptors in the brain. In the drug trials, the number of increased sexually satisfying events was low, a point of criticism during the approval process. But patients have argued in public testimony that it is not about the number of events, but the fact they wanted to have sex again.
In approving flibanserin for use, the FDA did more than add to treatment options. The committee validated sexual desire as a medical problem and gave credibility to research in sexual medicine. I hope pharma will invest in research for an on-demand drug, and perhaps combine molecules with hormone therapy such as testosterone.
In the meantime, with PLISSIT in one hand, and a timer in the other, I continue to listen to and validate my patient's sexual health concerns in this time of healthcare challenges.
"Lady Doc" is , director of in Grand Rapids, Mich. After 20 years in obstetrics and gynecology, Bitner wrote "" (2014), an educational tool for patients and providers.