Hypoactive Sexual Desire Disorder in women has been recognized by the American Psychiatric Association since the publication of the 3rd edition of the Diagnostic and Statistical Manual of Mental Disorders. This disorder is based either on a long-term history of low sexual desire or a gradual decline. To be characterized as a disorder, the low levels of sexual desire must be a source of distress for the woman. The primary treatment for low sexual desire in women are two drugs recently approved by the US Food and Drug Administration.
The first drug, approved in 2015, was Addyi. Addyi was developed as an antidepressant, that failed in its clinical trials. Based on a few anecdotal reports, ADDYI was rebranded as a drug to treat Hypoactive Sexual Desire Disorder (HSDD). The drug was found to have no effect over placebo (control treatment) and as such the application for new drug approval was denied twice by the FDA. A strong lobbying effort, led by individuals with a financial stake in Addyi, persuaded the FDA to approve the drug. The lack of clinical efficacy is accompanied by a disturbing side effect profile, making this an ideal drug! The drug needs to be taken for weeks to reach its minimal effect, during which the woman taking the drug gets the benefit of the side effects.
Vyleesi was the second drug approved for HSDD, and in 2019 was touted as the first on-demand treatment for HSDD. Vyleesi was developed as an adjunct agent to go along with pro-erectile drugs in men (e.g., Viagra). Its remarketing for women made no sense, and a new drug application was made to the FDA with very little preclincal data to support its use in women. The drug also had minimal efficacy over placebo with respect to treating HSDD. Further, the drug made upwards of 40% of women nauseous, and produced dark pigmentation patches in a smaller percentage of women. Vyleesi needs to be given about 45 minutes before the woman engages in sex to be effective. And the drug needs to be injected. Spontaneity does not factor into sexual desire apparently. A second marginally effective drug with a poor side effect profile.
Why did these drugs get approved? An element of the approval was an argument of sexism on the part of a pharmaceutical industry that had marketed several drugs for treating sexual dysfunction in men and none for women. It is not clear how developing and approving two ineffective drugs combats that sexism, but so it goes.
The other element is why do women with HSDD need to be drugged? Women (and men) have reduced levels of sexual desire over their lifetimes and over the duration of extended relationships. This is normal…not drugable. Further, where does the loss of sexual satisfaction come from and what is the source of distress? Some of comes from the woman herself, where the development of a poor self-image, insecurities in a relationship, and simply fatigue from a stressful lifestyle can contribute to lowered sexual desire. The distress comes from conflicts in a relationship between the woman (in a cis-gendered heterosexual relationship) and her male partner who has higher levels of sexual desire and interest.
All of this is normal, not pathological as the Diagnostic and Statistical Manual would have you believe. The relationship conflicts are real, but the treatment is counseling, not drugs. Women do not need another source of stress or reasons to feel badly about themselves. Developing open communication about normal changes in relationships and developing strategies for both partners to work together to maintain those bonds are valuable solutions. Pathologizing the normal behavior and feelings of women is not.
The Science of Sex and Aggression 