Q & A’s About Flibanserin (Addyi), the New ‘Viagra for Women’

AddyiWhat is Addyi?
Addyi is a non-hormonal prescription pill used to treat Hypoactive (low) Sexual Desire Disorder (HSDD) in women who have not gone through menopause and who have low sexual desire no matter the type of sexual activity, the situation, or the sexual partner.

Who should take Addyi?
This medication is intended for women with low sexual desire that are highly motivated to flip their libido switch back on not only for their own pleasure, but often to save a marriage or relationship sabotaged by the absence of normal sexual relations.

Who should not take Addyi?
Do not take Addyi if you:

  • if you are a moderate to heavy alcohol user
  • if you are taking any of the following medicines:
    • medicines used to treat HIV-1 infection
    • medicines that you take by mouth used to treat fungal infections – certain antibiotics, including:
      • ciprofloxacin (CIPRO, CIPRO XR)
      • telithromycin (KETEK®)
      • erythromycin (ERY-TAB®, ERYC®, PCE®)
      • clarithromycin (BIAXIN®)
  • medicines used to treat Hepatitis C infection
  • medicines used to treat high blood pressure, chest pain (angina), or other heart problems
  • nefazodone: a medicine used to treat depression
  • if you have liver problems

Can you elaborate on interactions between alcohol and flibanserin?
Drinking was allowed in the studies for this new drug, and the women in the clinical trial who identified as “social drinkers” (58 percent of the participants) did not have any significant issues.

The FDA was particularly concerned about binge drinking, so they required an alcohol challenge test to reproduce what heavy drinkers would experience if they were on Addyi. Some of the participants in that study had a drop in blood pressure or passed out.

Interactions with alcohol need to be discussed just as they would with any drug that affects your central nervous system. All centrally-acting drugs (think antihistamines, antidepressants, and hundreds of other drugs) are known to interact with alcohol, and the FDA requires a similar warning for these.

How common is loss of lust?
Of all sexual problems, loss of lust is by far the most common. Up to 1 in 10 adult women are affected by HSDD.

How does Addyi work?
Addyi works on a woman’s brain to balance neurotransmitters and restore normal sexual desire. The drug, is more akin to an antidepressant as it changes brain chemistry similar to the way that dopamine and serotonin do.

How many women have taken Addyi?
More than 11,000 women participated in the flibanserin clinical trials. As of October 17, 2015, Addyi has become available by prescription from healthcare providers trained on Addyi usage.

How well does Addyi work?
Women reported a 53 percent increase in sexual desire, their number of satisfying sexual events doubled, and their distress about sexual function decreased by 29 percent.

Many women suffering from HSDD argue that it’s up to them to determine if the benefits outweigh the risks. Testifying before the FDA in June, a number of them urged the agency to approve the drug.

How soon will it work?
Flibanserin usually starts to show positive effects two to four weeks after a woman begins taking the drug. If you see no difference in two or three months, stop taking Addyi. It’s not going to help you.

I heard the FDA initially turned down this new “female Viagra.” Why?
The FDA is careful and demands a lot of information before approving a drug. In the United States, it usually takes 12-15 years for a proposed drug to appear in your pharmacy. Only 1 in 5,000 new drugs makes the final cut. Along the way, it’s very common for the FDA to require additional studies.

In the case of Addyi, more than 60 studies were submitted to the FDA. One of the side effects in people who took Addyi in clinical trials was sleepiness. In response, the FDA required a driving test to assure that women taking Addyi at night were not drowsy or impaired the next morning. The result? The women who took Addyi actually drove better than the women who did not.

Risks / Side Effects
Taking Addyi with certain other medicines can increase the amount of Addyi in your blood and cause severe low blood pressure, fainting (loss of consciousness), and sleepiness.

The most common side effects of Addyi include dizziness, nausea, tiredness, dry mouth and difficulty falling asleep or staying asleep.

How Do I Take Addyi?
Take 1 Addyi tablet every day at bedtime.

How do I get Addyi?
To learn more, call an Arizona OB/GYN Affiliates (AOA) at 602-343-6174 or visit www.aoafamily.com. All providers at AOA have been trained on Addyi usage.

SOURCES:

  1. Addyi.com
  2. FDA Briefing Document. FDA.
  3. FDA Approves First Treatment For Sexual Desire Disorder. FDA.
  4. Sexual problems and distress in United States women: prevalence and correlates. Pubmed
  5. 25 Facts About Flibanserin (Addyi), the New ‘Viagra for Women’
  6. Addyi: Why The New “Female Viagra” Is The Best Thing That Ever Happened
  7. Addyi: Still Good the Morning After?
  8. FDA approves ‘female Viagra’ pill Flibanserin after two rejections