Preclinical studies have shown that flibanserin is a highly selective postsynaptic serotonin (5HT)1A antagonist and 5HT2A antagonist and may also act as an antagonist at 5HT2C and 5HT2B receptors and dopamine D4 receptors.^7,15

Allthough the exact mechanism of action is unknown, collectively, these effects are believed to increase dopamine and norepinephrine, and transiently decrease serotonin, to restore the appropriate balance of excitatory and inhibitory activity of brain reward centers to the prefrontal cortex.¹⁵

In clinical trials, improvements in HSDD symptoms (increase in sexual desire, increase in satisfying sexual events, decrease in associated distress) were observed as early as 4 weeks after starting Addyi. Not all women will experience similar improvement in their HSDD.⁷

Improvements can be subtle at first, with gradual improvement. It is important to follow up with women prescribed Addyi to discuss improvements in their HSDD symptoms. Addyi should be discontinued if there is no improvement after 8 weeks.⁷

Taking Addyi after consuming alcohol increases the risk of severe hypotension and syncope. To reduce this risk, counsel patients to wait at least two hours after drinking one or two standard alcoholic drinks* before taking Addyi at bedtime. Counsel patients who drink three or more standard alcoholic drinks to skip their Addyi dose that evening. After taking Addyi at bedtime, advise patients to not use alcohol until the following day.⁷

No, Addyi is not a hormone or a hormonal treatment. Addyi is a centrally acting multifunctional serotonergic agonist and antagonist. Based on findings from preclinical studies, it is thought that Addyi transiently decreases serotonin activity and increases dopamine and norepinephrine activity to restore an appropriate balance of excitatory and inhibitory activity of the brain reward centers to the prefrontal cortex. The exact mechanism of action is unknown.¹⁵

Through PhilRX the Addyi coupon is automatically applied.

*Eligible patients only. Restrictions apply. See Terms and Conditions.

Addyi is taken once daily at bedtime to treat hypoactive sexual desire disorder (HSDD) symptoms. Addyi is not a cure for HSDD. Women who experienced improvements in their HSDD symptoms, including an increase in sexual desire, a decrease in associated distress, and an increase in satisfying sexual events, may notice that their symptoms return once they stop taking Addyi.¹⁶

With insurance coverage?
Addyi is as low as $20 per month.

Is your patient paying cash?
Addyi is $149 per month.

Does your patient need a coupon for her local pharmacy?
If your patient prefers an in-person pharmacy, have her visit goodrx.com/addyi and redeem a coupon for Addyi.

Patients who want to stop taking Addyi do not need to taper their Addyi tablets. Abrupt discontinuation of Addyi is not associated with withdrawal symptoms.

During a randomized trial in 738 women with HSDD, adverse events associated with withdrawal from CNS medications (specifically serotonergic medications) were compared among women who had taken Addyi for 48 weeks vs women who had taken Addyi for 24 weeks followed by placebo for 24 weeks. No evidence of withdrawal reactions was observed following the abrupt discontinuation of flibanserin after 24 or 48 weeks of treatment.¹⁶

The most common adverse reactions occurring in < 2% of women treated with Addyi 100 mg at bedtime (n=1543) and at a higher incidence than with placebo (n=1556), during the clinical trials, were dizziness (11.4%), somnolence (11.2%), nausea (10.4%), fatigue (9.2%), insomnia (4.9%), and dry mouth (2.4%). Most of these adverse reactions began within the first 14 days of starting Addyi.

Less common adverse reactions occurring in ≥1% but <2% of Addyi-treated women and at a higher incidence than with placebo during these clinical trials include anxiety (1.8%), constipation (1.6%), abdominal pain (1.5%), metrorrhagia (1.4%), rash (1.3%), sedation (1.3%) and vertigo (1%).⁷

Most clinical studies of women with hypoactive sexual desire disorder (HSDD) evaluated 24 weeks of Addyi treatment. However, one long-term safety study looked at the safety of various doses of flibanserin (N=1723) over an extended 52-week treatment period. During this study, 883 women took the FDA-approved Addyi 100 mg dose for ≥180 days.

The most common adverse events reported during the 52-week study were similar to those observed in the 24-week studies, including somnolence (15.8%), sedation (1.6%), fatigue (7.6%), dizziness (6.9%), nausea (6.3%) and vomiting (1.4%). The most common adverse events leading to early study discontinuation included depression (1.1%), anxiety (0.9%), dizziness (0.8%), fatigue (0.7%), and insomnia (0.6%).¹⁷

Taking Addyi once daily at bedtime is not associated with weight gain.

In the clinical trials for Addyi, body weight was measured at the beginning and during the 24-week study period to assess weight changes. Among women enrolled in these clinical trials, weight gain ≥7% at the end of the study compared to when they started the study occurred in 1.8% of Addyi-treated women compared to 3.4% of women who received placebo.¹⁸

You can read more about clinical trials here.

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