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What Should I Know About Addyi?

Aug 26, 2015

What Should I Know About Addyi?There’s been a lot of talk about Addyi – on TV, on the internet, maybe even among your friends. Approved by the FDA on August 18th, it’s the first drug designed to treat acquired, generalized hypoactive sexual desire disorder (HSDD). In general terms, HSDD refers to low sexual desire in women, but there’s a little more to it than that.

According to Sprout Pharmaceuticals, the maker of Addyi, the drug should be available by October 17th. Between now and then, it’s important to understand just what Addyi is, whom it is intended for, and what patients might expect.

In today’s post, we answer some common questions about Addyi. Keep in mind that only your doctor can best advise on whether Addyi is right for you or your partner.

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What is HSDD?

It’s normal for women to experience fluctuations in sexual desire. Life gets busy and stressful, relationships can get rocky, and hormonal changes during pregnancy and menopause can all interfere with our interest in sex. So can certain medications, like antidepressants.

What makes HSDD different is that it can’t be explained by life circumstances, medications, or another health situation. It also causes women distress or disrupts their personal relationships. Distress is important in an HSDD diagnosis. If a woman lacks sexual interest but isn’t bothered by it, she doesn’t have HSDD.

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What is Addyi and how does it work?

Addyi’s technical name is flibanserin. It’s a non-hormonal drug that acts on neurotransmitters in a woman’s brain. Two of these neurotransmitters – dopamine and norepinephrine – are involved with sexual excitement. Addyi raises levels of these chemicals. Another neurotransmitter, serotonin, is associated with sexual inhibition. Addyi lowers serotonin levels. By balancing out these chemicals, Addyi may help restore a woman’s sexual interest.

Addyi is taken once a day at bedtime. It is not meant to enhance sexual performance. In other words, it won’t make sex feel more exciting. But it might help a woman feel more excited about having sex.

Who can take Addyi?

While all women can experience low sexual desire, not all women can take Addyi.

The FDA has approved Addyi for specifically for women who meet the following conditions:

·         Are pre-menopausal. Your doctor can help you determine your menopause status. Typically, a woman is considered to be finished with menopause if she hasn’t had a menstrual period in twelve months.

·         Have acquired HSDD. This means that the woman has had a healthy sex drive in the past. She hasn’t had HSDD for her entire life.

·         Have generalized HSDD. When HSDD is generalized, it occurs in all sexual situations with all partners. Sometimes, women lose interest in sex because it’s routine. New activities or new partners can rekindle their libido. But this doesn’t happen with generalized HSDD.

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Who cannot take Addyi?

Addyi is not recommended for:

·         Women who have finished menopause.

·         Men

·         Women who have poor liver function

·         Women who take a class of drug called CYP3A4 inhibitors (If you don’t know, ask your doctor.)

·         Women who regularly drink alcohol. Addyi and alcohol do NOT mix.

What are the side effects of Addyi?

Women who take Addyi may feel dizzy or sleepy. Nausea, fatigue, insomnia, and dry mouth are other reported side effects.

Is Addyi safe?

Extensive studies have found that Addyi is safe for women as described above. However, there are still safety risks.

Syncope (fainting, loss of consciousness) and hypotension (extremely low blood pressure) have been reported among women who take Addyi, especially if they drink alcohol, have liver problems, or take CYP3A4 inhibitors.

As part of the approval process, Sprout Pharmaceuticals is required by the FDA to conduct further studies on the interaction of Addyi with alcohol.

Also, doctors and pharmacies are required to undergo a training and certification process before they are allowed to prescribe or dispense Addyi.

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Is Addyi effective?

There have been some concerns about how well Addyi works. And it might not work for all women.

However, clinical trial results are encouraging. According to the International Society for Sexual Medicine (ISSM), in studies of over 11,000 women, 53% of participants felt improvements in sexual desire. The number of satisfying sexual events doubled and sexual distress was reduced by one-third.

Is Addyi right for me?

That’s something only you and your doctor can answer.

If you feel that your sexual interest has declined, make an appointment for a full checkup. Your doctor can assess the medications you take, your hormone levels, your relationship, and the day-to-day stresses in your life. He or she might also use a tool called the Decreased Sexual Desire Screener to evaluate your symptoms.

If you and your doctor decide to that Addyi is appropriate, you can discuss next steps. Keep in mind that your doctor might not be certified to prescribe Addyi and that it may not be covered by your insurance.

If you do take Addyi, do NOT drink alcohol. Be sure to notify your doctor or other healthcare professional if you have any concerning side effects. It’s also critical that your other doctors – present and future – know that you are taking Addyi to avoid drug interactions.


Print this article or view it as a PDF file here: What Should I Know About Addyi?


Resources

International Society for Sexual Medicine

“Flibanserin approved as the 1st pharmacologic treatment option for women suffering from HSDD”

(August 18, 2015)

http://www.issm.info/news/flibanserin-approved-as-the-1st-pharmacologic-treatment-option-for-women-su

“What is flibanserin and how does it work?”

http://www.issm.info/education-for-all/sexual-health-qa/what-is-flibanserin-and-how-does-it-work/

Medicine.net

“Definition of syncope”

(Last editorial review: August 28, 2013)

http://www.medicinenet.com/script/main/art.asp?articlekey=5612

NPR

Stein, Rob

“FDA Approves First Drug To Boost Women's Sexual Desire”

(August 18, 2015)

http://www.npr.org/sections/health-shots/2015/08/18/432704214/addyi-fda-approves-drug-to-boost-womens-desire

Sprout Pharmaceuticals

“Sprout Pharmaceuticals Receives FDA Approval of ADDYI™ (Flibanserin 100 MG)”

(Press release. August 18, 2015)

http://www.sproutpharma.com/sprout-pharmaceuticals-receives-fda-approval-addyi-flibanserin-100-mg/

U.S. Food and Drug Administration

“FDA approves first treatment for sexual desire disorder”

(News release. August 18, 2015)

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm458734.htm