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 appears to corrects an imbalance of the neurotransmitters (brain chemical messengers) dopamine and norepinephrine (both responsible for sexual excitement), while decreasing levels of serotonin (which can lower sex drive).
• Addyi works in the brain and many of its side effects, like dizziness and drowsiness, are due to its central nervous system action there, too.
• As with many drugs, the exact mechanism is not known, according to FDA.

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 used to enhance sexual performance.

Learn More: Addyi dosing, side effects and warnings

Is Addyi Effective?

The effectiveness of Addyi was evaluated in three 24-week clinical trials in 2,400 premenopausal women with HSDD. On average, taking Addyi increased the number of satisfying sexual events by 0.5 to 1 additional event per month over placebo.

Roughly 10% more (10 out of every 100) Addyi-treated patients than placebo-treated patients reported meaningful improvements in satisfying sexual events, sexual desire or distress.

But a study in JAMA Internal Medicine found that effectiveness was even lower: treatment with Addyi, on average, resulted in only one-half additional satisfying sexual event per month while significantly increasing the risk of some troublesome side effects, like:

• dizziness
• somnolence (drowsiness)
• nausea
• fatigue.

However, there may be a certain subset of women who have success with Addyi to boost their libido. Discuss with your doctor if a trial of Addyi is a wise option for you.

Am I a Candidate for Addyi?

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)
• problems with a significant other (husband, partner)
• due to side effects of a drug

then Addyi is not for you.

What's the History Behind Addyi?

Originally, flibanserin was under research as a depression treatment. When FDA rejected approval of the drug for libido in 2010, Boehringer Ingelheim sold the drug to Sprout Pharmaceuticals.

Under Sprout's development, flibanserin as a treatment for low libido in women was rejected two more times by the FDA. Advisory members stated lack of effectiveness and risky side effects.

However, Sprout forged ahead, rounding out studies, creating "disease awareness" in the general public and with healthcare providers, and continuing to work with FDA to gain Addyi approval.

On August 20, 2015 Valeant Pharmaceuticals acquired Sprout Pharmaceuticals and Addyi for a massive $1 billion in cash, two days after Addyi approval.

Why Was There So Much Buzz With Addyi?

Women's groups heralded the approval of Addyi as finally meeting a significant unmet need. However, based on studies, there may be a small group of women for which this drug is effective. 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 were 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 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.