How does Addyi work and is it effective?

Addyi (flibanserin) works by balancing the brain chemicals such as dopamine and norepinephrine that may lead to lowered sex drive in some women. About 10% more patients who received Addyi than placebo reported meaningful improvements in satisfying sexual events, sexual desire or distress.

• Addyi is a non-hormonal, multifunctional serotonin agonist antagonist (MSAA).
• Addyi appears to correct an imbalance of the neurotransmitters (brain chemicals) dopamine and norepinephrine (both responsible for sexual excitement), while decreasing levels of serotonin (which can lower sex drive).
• As with many drugs, the exact mechanism is not known.

Don't get caught up in all the specifics, however. The takeaway from all of this? 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.

Addyi was first approved by the FDA in August 2015 to treat hypoactive sexual desire disorder (HSDD) in premenopausal women. That's just another way of 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 (1 out of 10) premenopausal women in the U.S. It's not used to boost sex drive in postmenopausal women or in men.

Effectiveness of Addyi

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 the group receiving a placebo (inactive treatment).

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.

However, 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.

How fast does Addyi work?

You may notice improvement in your HSDD symptoms, like sexual desire, an increase in satisfying sexual events and a decrease in stress associated with HSDD within 4 weeks of starting treatment. Stop treatment if there is no improvement in 8 weeks.

Safety Issues

Common side effects with Addyi (at least 2% of patients) 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.

Addyi is taken as an orla tablet once daily at bedtime. However, the risk of severe low blood pressure and fainting, particularly when combined with alcohol, is a major problem with Addyi.

• 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). Wait at least 2 hours after drinking 1 or 2 standard alcoholic drinks before taking Addyi at bedtime. After you have taken your Addyi at bedtime do not drink alcohol until the following day. Skip your Addyi dose if you have consumed 3 or more drinks that evening.
• Do not take or start taking any prescription medicines, over-the-counter (OTC) medicines, vitamin or herbal supplements while taking Addyi until you have talked with your doctor. These combinations may not be safe and increase your risk of severe low blood pressure and fainting.
• Do not take Addyi if you have liver problems.
• If you take Addyi and you feel lightheaded or dizzy, lie down right away. Tell your doctor as soon as possible if you faint.

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.