From the Guidelines
Flibanserin, also known as Addyi, is a medication approved by the FDA to treat hypoactive sexual desire disorder (HSDD) in premenopausal women.
Key Points
- It is taken daily and has been shown to result in approximately 1 additional satisfying sexual event every 2 months in premenopausal women 1.
- The medication has been found to be effective in increasing sexual desire and reducing distress related to low sexual desire in premenopausal women with HSDD 1.
- Common side effects of flibanserin include dizziness, somnolence, nausea, and fatigue 1.
- While it is not FDA-approved for use in postmenopausal women, some data suggest it may be effective and safe in this population as well 1.
- Flibanserin has not been extensively studied in cancer survivors, but it may be a reasonable option to discuss with premenopausal survivors with low or lack of desire, libido, or intimacy 1.
Considerations
- The use of flibanserin should be considered on a case-by-case basis, taking into account the individual's medical history, current medications, and potential side effects.
- Alternative treatment options, such as bremelanotide, bupropion, and buspirone, may also be considered for premenopausal women with HSDD 1.
From the FDA Drug Label
ADDYI (flibanserin) is a tablet for oral administration. The chemical name of flibanserin is 2H-Benzimidazol-2-one, 1,3-dihydro-1-[2-[4-[3-(trifluoromethyl)phenyl]-1-piperazinyl]ethyl]. Flibanserin is a white to off-white powder, insoluble in water, sparingly soluble in methanol, ethanol, acetonitrile and toluene, soluble in acetone, freely soluble in chloroform, and very soluble in methylene chloride. Each ADDYI tablet contains 100 mg of flibanserin
Flibanserin (Addyi) is a tablet for oral administration, containing 100 mg of flibanserin, used for the treatment of premenopausal women with hypoactive sexual desire disorder. 2
From the Research
What is Flibanserin (Addyi)?
Flibanserin, also known by its brand name Addyi, is a medication indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women 3, 4, 5, 6, 7.
Mechanism of Action and Efficacy
- Flibanserin is a 5-hydroxytryptamine 5-HT1A agonist and 5-HT2A antagonist 3.
- It has been shown to improve sexual desire and reduce sexual distress associated with HSDD in premenopausal women 3, 5, 6, 7.
- Clinical trials have demonstrated that flibanserin is effective in increasing the number of satisfying sexual events (SSEs) and improving the Female Sexual Function Index (FSFI) desire domain score and the Female Sexual Distress Scale-Revised (FSDS-R) Item 13 score 3, 7.
Safety and Adverse Events
- Common adverse events associated with flibanserin include dizziness, somnolence, nausea, fatigue, and insomnia 3, 6, 7.
- Flibanserin has been shown to be well-tolerated and effective in clinical trials, with a favorable risk-benefit profile 6.
- However, the use of flibanserin may be associated with a higher risk of adverse events, particularly sedation- and hypotension-related events, and drug interactions with alcohol and antidepressants 6, 7.
Clinical Use and Recommendations
- Flibanserin is approved for the treatment of HSDD in premenopausal women and is available as a 100mg oral tablet taken once daily at bedtime 3, 4, 5, 6.
- Healthcare professionals should assess patients for HSDD and provide information about treatment options, including flibanserin, while ensuring patient comfort with the topic 5.
- Long-term pharmacovigilance data will be essential to monitor the safety and efficacy of flibanserin in clinical practice 6.