You may have heard about Addyi (flibanserin), a nonhormonal medicine approved by the FDA to treat low sex drive, also called hypoactive sexual desire disorder (HSDD) in women less than 65 years old.
HSDD is the most common cause of sexual dysfunction in women. Women with HSDD struggle with an ongoing lack of interest in sex that causes distress and relationship problems. It is typically reported in women who previously had normal sexual desire but have had symptoms for at least six months, causing distress over 75% of the time.
Common symptoms of HSDD may include:
- Low or no libido (sex drive)
- No sexual fantasies or thoughts
- Distress at the thought of having sex
- Loss of interest during sexual activity
- Avoiding sex or activities that could lead to sex
- Less or no pleasure or orgasms during sex most of the time
Below are some common questions and answers about Addyi for HSDD and whether it may be an option for you.
How Does Addyi Work for Low Sex Drive?
Addyi contains the active ingredient flibanserin. Addyi is thought to balance certain chemicals in the brain involved in sexual drive, such as dopamine, norepinephrine, and serotonin. These chemicals are important for normal sexual health and sexual desire.
Dopamine is associated with pleasure and reward pathways in the brain, with feelings of attraction, excitement, and motivation to initiate or respond to sexual contact. Norepinephrine is associated with excitement, energy, and focus due to sexual cues. Addyi may increase the levels of dopamine and norepinephrine, which may lead to increased sexual desire.
Too much serotonin can lower the effects of dopamine and norepinephrine, leading to decreased sexual desire. Addyi may help balance the level of serotonin in your brain, which may lower the inhibition of sexual thoughts or feelings.
While Addyi may help manage the symptoms of HDSS, it does not cure the disorder.
Is Addyi Right for Me?
Addyi may be right for you if you are less than 65 years old and have an ongoing lack of interest in sex that causes distress or relationship problems.
Addyi is not approved for use in men. It should not be used to improve sexual performance or for low sexual drive caused by medical or mental health problems, relationship problems, or another medicine.
Your health care provider may give you a screening tool to help talk about your symptoms and can check if Addyi may be right for you.
How Was Addyi Studied for HSDD?
The FDA approved Addyi for HSDD based on many studies that showed how well it works and how safe it is to use. These studies included both premenopausal and postmenopausal women.
- DAISY, BEGONIA, and VIOLET studies looked at Addyi in premenopausal women.
- PLUMERIA and SNOWDROP studies looked at Addyi in postmenopausal women aged less than 65 years.
The combined studies included almost 3,000 premenopausal women and about 800 naturally postmenopausal women with diagnosed HSDD. Women in the studies had the following traits:
- Everyone reported a low sex drive that caused them distress or problems in their relationship.
- Everyone was less than 65 years old and in a stable, long-term relationship with a partner who was willing to be sexually active.
- Most of the women were in their mid-30s to early 40s, had been struggling with low desire for at least six months, and reported previously having normal sexual desire.
- The average relationship duration was greater than 10 years, and the average duration of HSDD was five years.
- Most women had a low number of satisfying sexual events (SSEs) and high distress scores, based on the screening completed at the beginning of the studies, including some of the following:
- Structured clinical interviews to diagnose HSDD
- Electronic diary (e-diary) entries with the number of SSEs and the level of desire reported daily
- Sexual Interest and Desire Inventory-Female
- Female Sexual Function Index (FSFI)
- Female Sexual Distress Scale-Revised (FSDS-R)
- All of the studies had a four-week screening period and 24 weeks of treatment with Addyi or placebo. The PLUMERIA study was stopped early at 16 weeks.
Women could not join the studies if they had certain medical conditions or mental health problems or if they took certain medicines, such as antidepressants or sleep aids.
Everyone was randomly assigned to take Addyi or a placebo (a treatment that has no medicine) every day for 24 weeks. But no one knew if they were taking a pill with medicine or placebo. In all of the studies, the effect of Addyi was measured by the change in the number of SSEs, the level of sexual desire, or the reduction in their distress. Dosing, age of the women included, and measurements for each study are included in the table below.
Traits of the women included in the studies
Addyi or Placebo | Women Included | Outcome Measures | |
|---|---|---|---|
| DAISY study | 25 mg twice a day 50 mg once a day 100 mg at bedtime | Premenopausal Average age: 35 years | Improvements in SSE and desire based on diary entries |
| VIOLET study | 50 mg at bedtime 100 mg at bedtime | Premenopausal Average age: 35 years | Improvements in SSE and desire based on diary entries |
| BEGONIA study | 100 mg at bedtime | Premenopausal Average age: 36 years | Change in FSFI desire score and number of SSEs |
| PLUMERIA study | 100 mg at bedtime | Postmenopausal (< 65 years) Average age: 56 years | Change in FSFI desire score and number of SSEs |
| SNOWDROP study | 100 mg at bedtime | Postmenopausal (< 65 years) Average age: 55 years | Change in FSFI desire score and number of SSEs |
What Benefits of Addyi Were Seen in Studies?
After 24 weeks, people taking Addyi reported improvement in the number of SSEs and their sexual desire compared to women using placebo. The table below summarizes the percentages of people who had changes in SSEs and “desire” scores. People taking Addyi 100 mg had a bigger increase in the number of SSEs than those taking other doses of Addyi or placebo.
Changes in SSEs and desire scores from DAISY, BEGONIA, and VIOLET studies in premenopausal women
Placebo | Addyi 100 mg | Reported Benefit at the End of the Study | |
|---|---|---|---|
DAISY study
|
+1.1 +6.8 |
+1.9 +8.5 | 41.9% of women taking Addyi reported improvement compared with 24.2% taking placebo. |
BEGONIA study
|
+1.5 +0.7 |
+2.5 +1.0 | 44.7% of women taking Addyi reported improvement compared with 34.8% taking placebo. |
VIOLET study
|
+0.8 +6.9 |
+1.6 +9.1 | 38.6% of women taking Addyi reported improvement compared with 26.7% taking placebo. |
Changes in SSE and desire scores from PLUMERIA and SNOWDROP studies in postmenopausal women
Placebo | Addyi 100 mg | Reported Benefit at the End of the Study | |
|---|---|---|---|
PLUMERIA study
|
+0.7 +0.4 |
+1.0 +0.6 | 37.1% of women taking Addyi reported improvement compared with 29.2% taking placebo. |
SNOWDROP study
|
+0.6 +0.4 |
+1.0 +0.7 | 37.6% of women taking Addyi reported improvement compared with 28.0% taking placebo. |
The results showed meaningful improvements for many women taking Addyi, whereas some saw less improvement. Keep in mind that your results may differ from study results.
How Do I Take Addyi?
Addyi is a tablet that is taken by mouth once daily, only at bedtime. If you miss a dose, skip that dose, and take the next dose at bedtime the next day. Do not double the dose or take Addyi the next morning. Addyi is not taken on demand before sexual activity.
Do not drink alcohol close to the time you take Addyi because it may increase your risk of serious side effects, such as low blood pressure, fainting, or changes in alertness.
- Wait at least two hours before taking Addyi if you have had two standard alcoholic drinks.
- Skip your Addyi dose if you have had more than three standard alcoholic drinks.
- Do not drink alcohol after taking Addyi until the following day.
A standard alcoholic drink includes:
- One 12-ounce regular beer
- 5 ounces of wine
- 1.5 ounces of liquor or a shot
Do not take Addyi if you feel dizzy or lightheaded. It is best to lie down and rest. Get medical attention right away if your symptoms do not go away or if you faint.
How Can I Tell if Addyi Is Working?
You may see changes in your sexual desire or related distress within a few weeks of starting Addyi. It may take up to eight weeks to see the full effects. You can tell that the medicine is working if you notice more interest in sex or sexual activities or feel less bothered by your low desire. These changes may be small over time.
- More interest in sex may include:
- Thinking about sex more often or more easily
- Feeling more open to sex when a partner shows interest
- Feeling more “alive” with romantic or erotic cues
- Less emotional distress may include:
- Feeling less guilt, frustration, or sadness about not wanting sex
- Fewer issues with partner about sex
Talk with your health care provider if you feel that Addyi is not working after eight weeks of use.
How Can I Get Addyi? Can I Get It at Any Pharmacy?
Addyi requires a prescription from a health care provider. Your health care provider can send the prescription to your local pharmacy or directly to a specialty pharmacy. This pharmacy will work with you, your provider, and your insurance to fill the prescription. If you use the specialty pharmacy, they will work with you and your insurance provider to determine the cost and mail the medicine directly to your home.
Is There Any Cost Assistance Available for Addyi?
The cost of Addyi can vary depending on your insurance status. Some insurance plans may cover this medicine and some may not. Financial assistance may be available. The pharmacy will work with you and your insurance to determine if there is a savings program that helps lower the cost if you qualify. You can visit this website for more information.
