From the Guidelines
Addyi (flibanserin) is the recommended medication for premenopausal women with hypoactive sexual desire disorder (HSDD), prescribed at a dose of 100 mg taken orally once daily at bedtime, as supported by the most recent guidelines 1. The medication should be taken consistently each night to maintain effectiveness while minimizing side effects like dizziness, sleepiness, and hypotension. Some key points to consider when prescribing Addyi include:
- Patients must completely avoid alcohol while using Addyi, as this combination can cause dangerous drops in blood pressure and fainting.
- Treatment requires at least 8 weeks to determine effectiveness, and if no improvement occurs after 8-12 weeks, the medication should be discontinued.
- Before starting Addyi, patients should undergo evaluation to rule out other causes of low sexual desire such as relationship issues, depression, medication side effects, or hormonal imbalances.
- Flibanserin works by modulating neurotransmitters in the brain, specifically by acting as a serotonin receptor agonist/antagonist and dopamine agonist, which helps restore balance to the neural pathways involved in sexual desire.
- Common side effects include dizziness, somnolence, nausea, fatigue, and insomnia, which patients should be informed about before beginning treatment, as noted in recent studies 1. Other options for survivors with low or lack of desire, libido, or intimacy include off-label use of bupropion and buspirone, as suggested by the NCCN panel 1. However, the panel does not recommend the use of oral phosphodiesterase type 5 inhibitors (PDE5i) for female sexual dysfunction due to the lack of data regarding their effectiveness in women 1.
From the FDA Drug Label
ADDYI is indicated 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 psychiatric condition, • Problems within the relationship, or • The effects of a medication or other drug substance.
The medication Addyi (flibanserin) is used for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.
- Key points:
- Indication: Treatment of premenopausal women with acquired, generalized HSDD.
- Dosage: 100 mg administered orally once per day at bedtime 2.
- Limitations of use: Not indicated for the treatment of HSDD in postmenopausal women or in men, and not indicated to enhance sexual performance. The recommended dosage is 100 mg administered orally once per day at bedtime 2.
From the Research
Treatment for Hypoactive Sexual Desire Disorder (HSDD) in Premenopausal Women
- Addyi (flibanserin) is a medication approved by the US Food and Drug Administration (FDA) for the treatment of HSDD in premenopausal women 3, 4, 5.
- Flibanserin has been shown to cause statistically significant increases in the number of satisfying sexual events and in sexual desire scores on standardized/validated measures while reducing FSD-related distress of premenopausal women diagnosed with HSDD 3, 4.
- The side effects of flibanserin include dizziness, somnolence, nausea, and (rarely) syncope, and are comparable to other CNS drugs 3, 4.
Efficacy and Safety of Flibanserin
- A systematic review and meta-analysis of randomized clinical trials assessing efficacy and safety of flibanserin for the treatment of HSDD in women found that treatment with flibanserin resulted in one-half additional satisfying sexual event per month while statistically and clinically significantly increasing the risk of dizziness, somnolence, nausea, and fatigue 3.
- The quality of the evidence was graded as very low, and future studies should include women from diverse populations, particularly women with comorbidities, medication use, and surgical menopause 3.
Comparison with Other Treatments
- Flibanserin is the only FDA-approved treatment of HSDD, and it is a nonhormonal option designed specifically for the treatment of HSDD 4.
- Other medications, such as bupropion and buspirone, may be considered off-label treatments, but flibanserin and bremelanotide are the sole medications approved by the FDA for generalized acquired HSDD in premenopausal women 5.