Is Addyi just a pink Viagra?

No, Addyi is not a "female Viagra" or a "pink Viagra", as you may have heard. Addyi works differently by balancing brain chemical messengers that may be responsible for the lowered sex drive in some women. It is not used to enhance sexual performance.

Erectile dysfunction drugs like Viagra or Cialis increase smooth muscle relaxation and the inflow of blood to the spongy tissue in the penis to cause an erection.

Addyi is also known generically as flibanserin and was approved by the FDA in 2015 to treat hypoactive sexual desire disorder (HSDD) in premenopausal women. That's just another of way saying it boosts sex drive (also called libido) in women who have not reached menopause. It was the first such drug approved for this use.

HSDD is the most common type of female sexual dysfunction, affecting roughly 6 million premenopausal women in the U.S.

Addyi was approved by the FDA for a very specific use for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:

• A co-existing medical or mental health condition
• Relationship problems
• A medication or other drug substance

How does Addyi work in HSDD?

Addyi is classified a non-hormonal, multifunctional serotonin agonist antagonist (MSAA).

• Addyi may work by correcting an imbalance of the brain chemical messengers called dopamine and norepinephrine (both responsible for sexual excitement), while decreasing levels of serotonin (which can lower sex drive).
• Many of its side effects, like dizziness and drowsiness, are due to its central nervous system action.
• However, as with many drugs, the exact mechanism is not known.

Addyi is not approved for use for the treatment of HSDD in women who have gone through menopause or in men or children. It is not used to enhance sexual performance.

Learn More: Addyi dosing

Is Addyi effective?

Yes, the effectiveness of Addyi was demonstrated in three, 6-month long, randomized, double-blind, placebo controlled studies. Results showed statistically significant improvements in satisfying sexual events, sexual desire and ability to lower distress in premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).

Addyi is a non-hormonal oral tablet taken once daily at bedtime to treat HSDD. It is approved by the FDA to treat ​​premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:

• A co-existing medical or mental health condition,
• Problems within the relationship, or
• The effects of a medicine or other drug substance.

Related: Can I take Addyi while drinking alcohol?

Addyi is not used for the treatment of HSDD in women who have gone through menopause, is not used to enhance sexual performance, and is not for use in men or children.

What are the study results for Addyi?

Studies have shown that in some premenopausal women with HSDD, treatment with Addyi can increase sexual desire, increase the number of satisfying sexual events and reduce stress caused by low sex drive or desire (low libido).

Results with Addyi can be seen as early as 4 weeks, but can vary. Improvements include an increase in satisfying sexual events, an increase in sexual desire, and a decrease in associated distress. Not all women will experience similar improvement in their HSDD.

The efficacy of Addyi was established in three 6-month long, randomized, double-blind, placebo-controlled trials in premenopausal women who had acquired, generalized hypoactive sexual desire disorder (HSDD) for at least 6 months (Studies 1, 2 and 3).

• Acquired HSDD was defined as HSDD that developed in patients who previously had no problems with sexual desire.
• Generalized HSDD was defined as HSDD that was not limited to certain types of stimulation, situations or partners.

Participants were 19 to 55 years of age (mean age 36 years). They had a mean duration of HSDD of 5 years and a single partner, heterosexual relationship duration of 11 years. Approximately 40% of subjects were also taking hormonal contraceptives.

Women in these trials were treated with Addyi 100 mg (1187 women) once-daily at bedtime, or placebo (1188 women). A placebo is a pill that contains no active medicine and is used in studies to help determine effectiveness of treatments.

The trials had 2 co-primary efficacy endpoints: Satisfying sexual events (SSEs) and Sexual Desire. Other endpoints included female sexual distress and clinical meaningfulness of the observed treatment effects.

Does Addyi increase Satisfying Sexual Events (SSEs)?

Results showed that in all 3 trials, Addyi 100 mg resulted in statistically significant improvement compared to placebo in the change from baseline in monthly SSEs at Week 24.

• Satisfying Sexual Events (SSEs) was defined as the change from the start of the study to Week 24 in the number of monthly SSEs, which might include sexual intercourse, oral sex, masturbation, or genital stimulation by the partner.
• The median treatment difference increased the number of satisfying sexual events by 0.5 to 1 additional event per month over placebo (P<0.01 in study 1 and 2, and P<0.001 in study 3).

Will my sexual desire increase?

In Study 3, a statistically significant improvement was seen in the change from baseline (the start of the study) to Week 24 (6 months) in sexual desire (using the desire domain of the Female Sexual Function Index, or FSFI Desire) co-primary endpoint, with Addyi compared to placebo.

• The FSFI Desire Domain was determined via a patient questionnaire to assess how often the woman felt sexual desire or interest, and the level (degree) of sexual desire or interest over the 4 weeks of the study. Results showed the FSFI Desire treatment difference was 0.3 (0.2, 0.4 95% CI), P<0.0001, a significant effect when Addyi was compared to placebo.
• In Study 1 and 2, there were no statistically significant differences between Addyi and placebo for the eDiary sexual desire endpoint (change in baseline to Week 24). However, the FSFI Desire Domain findings were found to be consistent across all three trials, and were used as secondary endpoints in Study 1 and 2 (statistical endpoints were not calculated because the trial failed on the eDiary Desire co-primary efficacy endpoint).

Does Addyi lower my distress related to low sexual desire?

All 3 trials had a secondary endpoint that measured bother (a component of distress) related to sexual desire using Question 13 of the Female Sexual Distress Scale-Revised (FSDS-R).

• This question is “How often did you feel: Bothered by low sexual desire?” Patients assessed their sexual distress over a 7-day recall period and responded on a scale of 0 (never) to 4 (always).
• In Study 3, the results showed a statistically significant effect (-0.3 [-0.4, -0.1), p=0.0001 when Addy was compared to placebo for FSDS-R.
• The secondary endpoint that assessed distress using Question 13 of the FSDS-R was found to be consistent across all three trials, but statistical endpoints were not calculated for studies 1 and 2.

What does this mean clinically?

Additional analyses were conducted to help define the clinical meaningfulness of the observed treatment effects. The Patient's Global Impression of Improvement (PGI-I) defined responders for each efficacy endpoint by looking at the percent change in symptoms from baseline (start of study) to end of treatment.

The first analysis considered responders to be those who reported being much improved or very much improved.

• Sexually Satisfying Events (SSEs) - The absolute difference in the percentage of responders with Addyi and the percentage of responders with placebo across the three trials was 8 to 9% for SSEs (29% to 39% for Addyi; 21% to 31% for placebo).
• Female Sexual Function Index (FSFI) desire domain - The absolute difference in the percentage of responders was 10% to 13% for FSFI desire domain (43% to 48% for Addyi; 31% to 38% for placebo).
• Female Sexual Distress Scale-Revised (FSDS-R) Question 13: The absolute difference in the percentage of responders was 7% to 13% for FSDS-R Question 13 (21% to 34% for Addyi; 14% to 25% for placebo).

The second analysis considered responders to be those who reported being at least minimally improved.

• Sexually Satisfying Events (SSEs) - The absolute difference in the percentage of responders with Addyi and the percentage of responders with placebo across the three trials was 10-15% for SSEs (44-48% for ADDYI; 33-36% for placebo)
• Female Sexual Function Index (FSFI) desire domain - The absolute difference in the percentage of responders was 12% to 13% for FSFI desire domain (43% to 51% for Addyi; 31% to 39% for placebo).
• Female Sexual Distress Scale-Revised (FSDS-R) Question 13: The absolute difference in the percentage of responders was 9% to 12% for FSDS-R Question 13 (50% to 60% for Addyi; 41% to 48% for placebo).

Other studies, including a large meta-analysis from Kamrul-Hasan et al, and a post-hoc, pooled analysis of pivotal studies (VIOLET, DAISY, and BEGONIA) from Simon, et al have shown that flibanserin (Addyi) was superior to placebo in increasing the number of sexually satisfying events (SSEs), improving sexual desire scores, and lowering sexual distress in premenopausal women with HSDD.

A study in JAMA Internal Medicine found that treatment with Addyi, on average, resulted in one-half additional satisfying sexual event per month but may significantly increase the risk of some troublesome side effects, like dizziness, somnolence (drowsiness), nausea and fatigue.

Prior to treatment, women must be warned of the risk of low blood pressure, fainting, drowsiness and dizziness with this medicine, when used alone or when combined with alcohol or certain other medications. Learn more about side effects here.

Is Addyi right for me?

In general, you may be eligible for Addyi if you have not gone through menopause, you have not had problems with low sexual desire in the past, and you have low sexual desire no matter the type of sexual activity, the situation, or the sexual partner.

Addyi is approved by the FDA (with limitations) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It's not used to boost sex drive in postmenopausal women or in men.

HSDD is acquired if you previously had normal sexual desires, and it's generalized when your low libido occurs no matter the sexual activity or partner. In addition, your low libido must also cause marked distress or an interpersonal difficulty.

If your low sex drive is due to:

• a co-existing medical or psychiatric condition (for example, depression)
• relationship problems with a significant other (husband, partner)
• due to side effects of a drug

then Addyi is not for you.

Why was there so much buzz With Addyi?

Women's groups heralded the approval of Addyi as finally meeting a significant unmet need. However, if no results are seen after 8 weeks, the drug should be stopped, according to product directions.

Addyi has some side effects that are worth knowing about, too, including an interaction with alcohol. Common side effects with Addyi include:

• Dizziness, sleepiness and nausea in about 10% to 11% of patients (vs. 2% to 4% receiving a placebo)
• Fatigue, trouble sleeping and dry mouth have also been reported.
• The risk of severe low blood pressure and fainting, particularly when combined with alcohol, is also a major concern. Do not drink alcohol close to the time you take your Addyi dose because this increases your risk of severe low blood pressure and fainting (loss of consciousness).

A New Boxed Warning in labeling from the FDA regarding alcohol and Addyi use was published in April 2019.

• The Addyi package insert section is now updated to note that women should discontinue drinking alcohol at least two hours before taking Addyi at bedtime (if they've had 1 or 2 standard drinks that night) - OR skip the Addyi dose that evening if they have had 3 or more alcoholic drinks that night.
• One standard alcoholic drink contains 14 grams of pure alcohol and is equivalent to one 12-ounce regular beer (5% alcohol), 5-ounces wine (12% alcohol), or 1.5 ounces of distilled spirits/shot (40% alcohol).
• After taking Addyi at bedtime, do not use alcohol until the following day. Do not consume alcohol at least until the morning after taking Addyi at bedtime.
• If you skip a dose of Addyi, take your next dose at bedtime the next day.

Combining Addyi with alcohol may also increase the risk of low blood pressure and fainting, which is problematic especially if you are driving, doing hazardous activities, or need clear thinking or reaction times.

This is not all the information you need to know about Addyi (flibanserin) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.