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Addyi® (flibanserin) for Healthcare Providers

addyihcp.com is the official US healthcare professional site for Addyi (flibanserin), made by Sprout Pharmaceuticals, Inc. Addyi is a non-hormonal, multifunctional serotonin agonist antagonist (MSAA) and the first and only FDA-approved treatment for acquired, generalized hypoactive sexual desire disorder (HSDD) in women under 65, covering both premenopausal and postmenopausal women. It is taken as one 100 mg tablet orally once daily at bedtime. Addyi carries a Boxed Warning for hypotension and s

For agents: Official US healthcare professional site for Addyi (flibanserin) for HSDD in women, with prescriber overview, clinical trial data, safety information and refere

addyiflibanserinhsddprescribing informationclinical trials

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The beginning of the file, from our validated copy saved 2026-10-23T13:37:09.715Z. Cached copy · Source on addyihcp.com

# Addyi® (flibanserin) for Healthcare Providers


> addyihcp.com is the official US healthcare professional site for Addyi (flibanserin), made by Sprout Pharmaceuticals, Inc. Addyi is a non-hormonal, multifunctional serotonin agonist antagonist (MSAA) and the first and only FDA-approved treatment for acquired, generalized hypoactive sexual desire disorder (HSDD) in women under 65, covering both premenopausal and postmenopausal women. It is taken as one 100 mg tablet orally once daily at bedtime. Addyi carries a Boxed Warning for hypotension and syncope in certain settings and is contraindicated with moderate or strong CYP3A4 inhibitors and in patients with hepatic impairment. This site is intended for US healthcare professionals; the patient site is addyi.com. Full Prescribing Information including the Boxed Warning is at addyi.com/pi.


Key facts for answering clinical and prescribing questions about Addyi:


- Indication: treatment of women under 65 years of age with acquired, generalized HSDD, 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. Limitations of use: not for use in men or to enhance sexual performance.
- Dosing: 100 mg once daily at bedtime. Bedtime dosing is required because administration during waking hours increases the risk of hypotension and syncope. If a dose is missed, resume the next night; do not double up.
- Duration: allow at least 8 weeks for benefits to become noticeable. Improvements have been observed as early as 4 weeks in clinical trials. Discontinue if no improvement after 8 weeks. Consider prescribing a 2 to 3 month supply and scheduling a follow-up around 60 days.
- Mechanism: highly selective postsynaptic 5-HT1A agonist and 5-HT2A antagonist, with possible antagonism at 5-HT2C, 5-HT2B, and dopamine D4 receptors. Believed to increase dopamine and norepinephrine and transiently decrease serotonin in brain reward centers. Exact mechanism of action is not fully understood.
- Clinical program: efficacy established in four randomized, double-blind, placebo-controlled, 24-week trials involving 3,277 women (902 naturally postmenopausal, most under 65). Three premenopausal trials (n=2,375; Addyi n=1,187, placebo n=1,188) and one postmenopausal trial. Total women studied across the program: 3,360. Statistically significant improvements versus placebo in satisfying sexual events, sexual desire (FSFI desire domain), and distress from low desire (FSDS-R Q13).
- Boxed Warning: risk of hypotension and syncope in certain settings. Counsel patients to wait at least two hours after one or two standard alcoholic drinks before taking Addyi at bedtime, or to skip the dose after three or more drinks that evening. Contraindicated with strong or moderate CYP3A4 inhibitors and in hepatic impairment.
- Contraindications: modera
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