HSDD

Hypoactive sexual desire disorder (HSDD) refers to a woman’s chronic or ongoing lack of interest in sex, to the point that it causes her personal distress or problems in her relationships.

It’s normal for women to lose interest in sex from time to time. A woman’s libido can fluctuate throughout her life. It might be high when she’s feeling good about her relationship or if she’s excited about a new one. It might decrease when she’s under emotional stress or dealing with hormonal changes from pregnancy or menopause.

The important distinction with HSDD is that it causes personal distress. If a woman does not feel concerned about her sex drive, then she probably doesn’t have HSDD. She might have a lower libido than other women, but if she’s not bothered by it, then there generally isn’t a problem.

According to the Society for Women’s Health Research, HSDD is the most common female sexual dysfunction and affects about 1 in 10 women. It can happen at any age. The Mayo Clinic notes that as many as 40% of women have HSDD at some point in their lives, according to some studies. 5% to 15% of women have the problem continuously.

HSDD can be frustrating for a woman and her partner. But the good news is, it is a treatable condition. It may take some time to discover what’s causing it, but a woman with HSDD can return to a satisfying sex life.

Causes

HSDD is a complicated disorder with a number of possible causes. Sometimes, several underlying conditions contribute to HSDD all at once. There can be physical causes, such as hormonal fluctuations or surgery that changes a woman’s body image. There can also be psychological and emotional causes. Many women associate a positive emotional connection with their partner with pleasurable sex, so negative changes in a relationship can trigger a lack of interest.

Illnesses, such as diabetes, cancer, arthritis, and coronary artery disease, can weaken a woman’s sex drive. Similarly, medications, like those taken for depression and high blood pressure, can decrease her libido. Even fatigue can take its toll. A woman may just be too exhausted to want sex.

Women may experience lower sex drive during menopause, when levels of estrogen – a hormone that boosts libido – fall substantially. Women can also see testosterone levels drop during menopause. Testosterone is usually associated with a man’s sex drive, but it affects women, too.

Also, hormonal changes during and after pregnancy can make a woman less interested in sex. 

A number of psychological and emotional factors can affect a woman’s sex drive. She may have anxiety, depression, or poor self-esteem. She might be under a lot of stress. Or, she might be a victim of physical abuse, sexual abuse, or rape. 

Problems in her relationship can also be a factor. If her partner has been unfaithful or deceitful, her lack of trust may make her less interested in sex. Low sex drive might result if she and her partner don’t communicate well or haven’t resolved a fight. She and her partner might not have satisfactory sex to begin with because they don’t talk about their needs or what they like in bed. They might not know how to talk about it or are too embarrassed to do so. That can fuel low libido, too.

Did you know that hypoactive sexual desire disorder (HSDD) affects about 1 in 10 women? It’s the most common of female sexual dysfunctions, but it’s underdiagnosed and undertreated.

FDA Approves First Treatment for Sexual Desire Disorder

ADDYI: ”The Women’s Viagra”

Fill out the questionnaire to see if you may qualify for ADDYI.  Click here: Decreased Sexual Desire Screener

The U.S. Food and Drug Administration today approved ADDYI (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to ADDYI’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. HSDD is generalized when it occurs regardless of the type of sexual activity, the situation or the sexual partner.

“Because of a potentially serious interaction with alcohol, treatment with ADDYI will only be available through certified health care professionals and certified pharmacies,” continued Dr. Woodcock. “Patients and prescribers should fully understand the risks associated with the use of ADDYI before considering treatment.”

ADDYI can cause severely low blood pressure (hypotension) and loss of consciousness (syncope). These risks are increased and more severe when patients drink alcohol or take ADDYI with certain medicines (known as moderate or strong CYP3A4 inhibitors) that interfere with the breakdown of ADDYI in the body. Because of the alcohol interaction, the use of alcohol is contraindicated while taking ADDYI. Health care professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing ADDYI.

ADDYI is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU). The FDA is requiring this REMS because of the increased risk of severe hypotension and syncope due to the interaction between ADDYI and alcohol. The REMS requires that prescribers be certified with the REMS program by enrolling and completing training. Certified prescribers must counsel patients using a Patient-Provider Agreement Form about the increased risk of severe hypotension and syncope and about the importance of not drinking alcohol during treatment with ADDYI. Additionally, pharmacies must be certified with the REMS program by enrolling and completing training. Certified pharmacies must only dispense ADDYI to patients with a prescription from a certified prescriber. Additionally, pharmacists must counsel patients prior to dispensing not to drink alcohol during treatment with ADDYI.

ADDYI is also being approved with a Boxed Warning to highlight the risks of severe hypotension and syncope in patients who drink alcohol during treatment with ADDYI, in those who also use moderate or strong CYP3A4 inhibitors, and in those who have liver impairment. ADDYI is contraindicated in these patients. In addition, the FDA is requiring the company that owns ADDYI to conduct three well-designed studies in women to better understand the known serious risks of the interaction between ADDYI and alcohol.

ADDYI is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, but the mechanism by which the drug improves sexual desire and related distress is not known. ADDYI is taken once daily. It is dosed at bedtime to help decrease the risk of adverse events occurring due to possible hypotension, syncope and central nervous system depression (such as sleepiness and sedation). Patients should discontinue treatment after eight weeks if they do not report an improvement in sexual desire and associated distress.

The effectiveness of the 100 mg bedtime dose of ADDYI was evaluated in three 24-week randomized, double-blind, placebo-controlled trials in about 2,400 premenopausal women with acquired, generalized HSDD. The average age of the trial participants was 36 years, with an average duration of HSDD of approximately five years. In these trials, women counted the number of satisfying sexual events, reported sexual desire over the preceding four weeks (scored on a range of 1.2 to 6.0) and reported distress related to low sexual desire (on a range of 0 to 4). On average, treatment with ADDYI increased the number of satisfying sexual events by 0.5 to one additional event per month over placebo increased the sexual desire score by 0.3 to 0.4 over placebo, and decreased the distress score related to sexual desire by 0.3 to 0.4 over placebo. Additional analyses explored whether the improvements with ADDYI were meaningful to patients, taking into account the effects of treatment seen among those patients who reported feeling much improved or very much improved overall. Across the three trials, about 10 percent more ADDYI-treated patients than placebo-treated patients reported meaningful improvements in satisfying sexual events, sexual desire or distress. ADDYI has not been shown to enhance sexual performance.

The 100 mg bedtime dose of ADDYI has been administered to about 3,000 generally healthy premenopausal women with acquired, generalized HSDD in clinical trials, of whom about 1,700 received treatment for at least six months and 850 received treatment for at least one year. 

The most common adverse reactions associated with the use of ADDYI are dizziness, somnolence (sleepiness), nausea, fatigue, insomnia and dry mouth. 

The FDA has recognized for some time the challenges involved in developing treatments for female sexual dysfunction. The FDA held a public Patient-Focused Drug Development meeting and scientific workshop on female sexual dysfunction on October 27 and October 28, 2014, to solicit perspectives directly from patients about their condition and its impact on daily life, and to discuss the scientific challenges related to developing drugs to treat these disorders. The FDA continues to encourage drug development in this area.

Consumers and health care professionals are encouraged to report adverse reactions from the use of ADDYI to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch by calling 1-800-FDA-1088.

ADDYI is marketed by Sprout Pharmaceuticals, based in Raleigh, North Carolina.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. 



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