What is the use of Addyi (flibanserin)?

From the Guidelines

Addyi (flibanserin) is a medication that can be considered for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women, with a typical dosage of 100 mg taken once daily at bedtime, as recommended by the most recent guidelines 1.

Key Considerations

• The medication should be taken at bedtime to minimize the risk of side effects such as severe low blood pressure and fainting.
• Treatment should be discontinued after 8 weeks if no improvement in sexual desire is noticed.
• Common side effects include dizziness, sleepiness, nausea, and fatigue.
• Addyi works by affecting brain neurotransmitters, particularly serotonin, dopamine, and norepinephrine, which are involved in sexual desire regulation.

Important Notes

• Addyi is not appropriate for all cases of low sexual desire, particularly when the issue stems from relationship problems, medications, or medical conditions.
• A thorough evaluation by a healthcare provider is necessary before starting this treatment.
• The safety and efficacy of Addyi in postmenopausal women and those with a history of cancer or on endocrine therapy are uncertain, and its use in these populations should be approached with caution 1.

Alternative Options

• Other medications, such as bremelanotide, may also be considered for the treatment of HSDD in premenopausal women.
• Off-label use of bupropion and buspirone may also be considered, although the evidence for their effectiveness is limited.
• Topical prescription medications, such as vaginal estrogen and vaginal androgens, may be considered for the treatment of vaginal dryness and other genitourinary symptoms.

From the FDA Drug Label

The concomitant use of ADDYI with a moderate or strong CYP3A4 inhibitor is contraindicated. ADDYI is contraindicated in patients with hepatic impairment ADDYI can cause CNS depression (e.g., somnolence, sedation). The risk of CNS depression is increased if ADDYI is taken during waking hours, or if ADDYI is taken with alcohol or other CNS depressants, or with medications that increase flibanserin concentrations, such as CYP3A4 inhibitors

Key Points:

• Contraindications: Moderate or strong CYP3A4 inhibitors, hepatic impairment
• Adverse Reactions: CNS depression, hypotension, syncope
• Warnings and Precautions: Increased risk of CNS depression with other CNS depressants, alcohol, or CYP3A4 inhibitors
• Dosage and Administration: Take 1 tablet at bedtime, avoid taking during waking hours

2

From the Research

Overview of Addyi (Flibanserin)

• Addyi, also known as flibanserin, is a medication approved for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women 3.
• It is a nonhormonal option that works as a multifunctional serotonin agonist/antagonist to increase sexual desire and reduce distress associated with HSDD 3.

Efficacy of Flibanserin

• Studies have shown that flibanserin significantly improves sexual desire and reduces distress in premenopausal women with HSDD 4, 5, 6.
• A pooled analysis of three clinical trials found that flibanserin increased the number of satisfying sexual events and improved sexual desire scores compared to placebo 4.
• Another study found that flibanserin reduced distress related to low sexual desire and improved sexual function in premenopausal and postmenopausal women 5.

Safety of Flibanserin

• Common side effects of flibanserin include dizziness, somnolence, nausea, and fatigue 4, 5, 6.
• A systematic review and meta-analysis found that flibanserin increased the risk of dizziness, somnolence, nausea, and fatigue compared to placebo 6.
• However, the overall safety profile of flibanserin is considered similar to other central nervous system (CNS) drugs 3.

Use in Postmenopausal Women

• While flibanserin is only approved for use in premenopausal women, some studies suggest that it may also be effective in postmenopausal women with HSDD 5, 7.
• A randomized controlled trial found that flibanserin improved sexual desire and reduced distress in postmenopausal women with HSDD, although the study was discontinued early due to sponsorship issues 7.