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Fli4.5
Flibanserin Research
Mostly mechanism / observational
13 peer-reviewed studies
What the evidence says
Mostly mechanism / observational
Most Flibanserin studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.
Most evidence is from medium-quality meta-analyses and randomised trials published 2010–2026 with a typical study size of 949 participants.
Based on 13 studies · 2 meta-analyses · 7 RCTs · 19,215 total participants
Confidence
High confidence
By outcome
Safety profile
Mostly mechanism / observational6 studies
Energy & fatigue
Mostly mechanism / observational4 studies
Women's health
Mostly mechanism / observational3 studies
Sleep & insomnia
Too few graded studies2 studies
Depression & mood
Too few graded studies2 studies
Therapeutic & clinical
Too few graded studies2 studies
Heart & blood pressure
Too few graded studies1 study
Migraine & headache
Too few graded studies1 study
Steady research
2 studies in the last 5 years · Latest meta-analysis: 2024
201020182026
1Meta-Analysisn=5,914 · very large study2016
In plain English: Treatment with flibanserin, on average, resulted in one-half additional satisfying sexual event per month while statistically and clinically significantly increasing the risk of dizziness, somnolence, nausea, and fatigue.
Jaspers L, Feys F, Bramer WM, Franco OH, Leusink P, Laan ET · JAMA Internal Medicine (2016)
Systematic review and meta-analysis of 5 published and 3 unpublished randomized trials including 5,914 premenopausal and postmenopausal women
Pooled mean difference for change in satisfying sexual events was 0.49 (95% CI, 0.32-0.67) for 100-mg flibanserin versus placebo; 1.63 (95% CI, 0.45-2.82) for eDiary desire and 0.27 (95% CI, 0.17-0.38) for FSFI desire
Risk ratios versus placebo: 4.00 (95% CI, 2.56-6.27) for dizziness, 3.97 (95% CI, 3.01-5.24) for somnolence, 2.35 (95% CI, 1.85-2.98) for nausea, 1.64 (95% CI, 1.27-2.13) for fatigue, and 2.19 (95% CI, 1.50-3.20) for discontinuation due to adverse events
In plain English: While flibanserin has demonstrated efficacy in the treatment of HSDD in both pre- and postmenopausal women, its therapeutic advantages may be overshadowed by the higher likelihood of adverse events.
Kamrul-Hasan ABM, Hannan MA, Alam MS, Aalpona FTZ, Nagendra L, Selim S, Dutta D · Medicine (Baltimore) (2024)
Systematic review and meta-analysis of 8 randomized controlled trials involving 7,906 women with hypoactive sexual desire disorder
In premenopausal women, flibanserin 100 mg improved satisfying sexual events per month (mean difference 0.69, 95% CI 0.39-0.99), eDiary sexual desire score (1.71, 95% CI 0.43-2.98), FSFI desire domain (0.30, 95% CI 0.29-0.31) and FSFI total score (2.51, 95% CI 1.47-3.55)
More women on flibanserin achieved improvement on the Patient's Global Impression of Improvement (OR 1.93, 95% CI 1.58-2.36) and responded positively at Patient Benefit Evaluation (OR 1.76, 95% CI 1.34-2.31); postmenopausal women also benefited
In plain English: In premenopausal women with HSDD, flibanserin 100 mg once daily was well tolerated and associated with statistically significant improvements in SSE, sexual desire (FSFI desire domain score but not eDiary desire score), sexual function, and decrease in sexual distress vs. placebo.
Thorp J, Simon J, Dattani D, Taylor L, Kimura T, Garcia M Jr, Lesko L, Pyke R · The Journal of Sexual Medicine (2012)
DAISY: 24-week randomized trial in North American premenopausal women with HSDD (mean age 35), assigned to flibanserin 25 mg twice daily (n=396), 50 mg twice daily (n=392), 100 mg once daily at bedtime (n=395), or placebo (n=398)
Only flibanserin 100 mg once daily increased satisfying sexual events versus placebo (P<0.01); the 25 mg and 50 mg twice-daily doses did not
No group showed a significant increase in the co-primary eDiary sexual desire score versus placebo — a missed co-primary endpoint
In plain English: Flibanserin 50 mg and 100 mg once daily at bedtime were well tolerated and associated with statistically significant improvements in SSE, sexual desire (FSFI desire domain score but not eDiary desire score) and overall sexual function, and reduction of sexual distress, vs. placebo.
Derogatis LR, Komer L, Katz M, Moreau M, Kimura T, Garcia M Jr, Wunderlich G, Pyke R · The Journal of Sexual Medicine (2012)
VIOLET: 24-week randomized trial in North American premenopausal women with HSDD — placebo (n=295), flibanserin 50 mg (n=295) or flibanserin 100 mg (n=290) once daily at bedtime
Both flibanserin doses increased satisfying sexual events versus placebo (P<0.05 and P<0.01 respectively)
The co-primary eDiary desire score showed only a numerical trend on flibanserin 100 mg and did not reach statistical significance (P=0.07 vs placebo)
In plain English: In premenopausal women with HSDD, flibanserin 100 mg qhs resulted in significant improvements in the number of SSE and sexual desire (FSFI desire domain score) vs. placebo.
Katz M, DeRogatis LR, Ackerman R, Hedges P, Lesko L, Garcia M Jr, Sand M · The Journal of Sexual Medicine (2013)
BEGONIA: 24-week randomized placebo-controlled trial in premenopausal women with HSDD (mean age 36.6) treated with flibanserin 100 mg once daily at bedtime (n=542) or placebo (n=545)
Mean satisfying sexual events increased 2.5 (SD 4.6) on flibanserin versus 1.5 (SD 4.5) on placebo — a large placebo response with a modest increment
FSFI desire domain rose 1.0 vs 0.7, FSFI total 5.3 vs 3.5; FSDS-R Item 13 fell -1.0 vs -0.7 and FSDS-R total -9.4 vs -6.1 (all P ≤ 0.0001)
In plain English: In naturally postmenopausal women with HSDD, flibanserin, compared with placebo, has been associated with improvement in sexual desire, improvement in the number of SSEs, and reduced distress associated with low sexual desire, and is well tolerated.
Simon JA, Kingsberg SA, Shumel B, Hanes V, Garcia M Jr, Sand M · Menopause (2014)
SNOWDROP: 24-week randomized trial in naturally postmenopausal women with HSDD — flibanserin 100 mg once daily at bedtime (n=468) or placebo (n=481)
Satisfying sexual events increased 1.0 (SE 0.1) versus 0.6 (SE 0.1) on placebo; FSFI desire domain 0.7 versus 0.4; FSFI total 4.2 versus 2.7 (all P<0.01)
FSDS-R Item 13 fell -0.8 versus -0.6 and FSDS-R total -8.3 versus -6.3; 37.6% of flibanserin-treated women versus 28.0% on placebo reported meaningful benefit on discontinuation
In plain English: At the end of the 24-week randomized withdrawal phase of a 48-week trial in premenopausal women with HSDD, flibanserin was superior to placebo on measures of SSE, sexual desire, overall sexual function, and sexual distress.
Goldfischer ER, Breaux J, Katz M, Kaufman J, Smith WB, Kimura T, Sand M, Pyke R · The Journal of Sexual Medicine (2011)
738 premenopausal women received 24 weeks of open-label flexible-dose flibanserin (50 or 100 mg/day); predefined responders were then randomized to continued flibanserin (n=163) or placebo (n=170) for 24 further weeks
During the open-label period mean satisfying sexual events and desire score approximately doubled, and FSFI and FSDS-R scores improved
At the end of the double-blind withdrawal phase, flibanserin remained superior to placebo on satisfying sexual events, desire score, FSFI desire and total scores, and FSDS-R total and Item 13 scores (P<0.05 for all) — indicating benefit depends on continued dosing
In plain English: In August 2015, the US Food and Drug Administration (FDA) made the controversial decision to approve flibanserin (Addyi) for women experiencing hypoactive sexual desire disorder.
Baksh SN, Gellad WF, Alexander GC · Drug Safety (2016)
Documents the FDA approval history: the product had two prior failed FDA reviews before the August 2015 approval
Attributes the disagreement over the decision to the unmet need, extensive advocacy and politicization surrounding the product's relevance to women and sexual health, the potential for widespread off-label use, and the product's tenuous risk/benefit profile
Identifies numerous drug-drug interactions and concomitant alcohol use as the two exposures that potentiate the risks of dizziness, hypotension and syncope
In plain English: Flibanserin, at steady state taken 2, 4, or 6 hours after 0.4 g/kg of ethanol intake did not increase the incidence of hypotension, orthostatic hypotension, or syncope compared with either flibanserin alone or ethanol alone.
Simon JA, Clayton AH, Kingsberg SA, Parish SJ, Kim NN, Millheiser L · The Journal of Sexual Medicine (2019)
Randomized, double-blind, placebo-controlled 4-treatment crossover study in 64 healthy premenopausal women (mean age 32.5) receiving once-daily flibanserin 100 mg or placebo at steady state
Participants consumed 0.4 g/kg ethanol (about two 5-oz glasses of wine) 2, 4 or 6 hours before study medication, or orange juice alone
Only 1 participant met the primary endpoint (syncope), and that occurred on placebo taken 4 hours after ethanol; hypotension rates were 53.3-66.7% after flibanserin versus 57.4-63.3% after placebo, and orthostatic hypotension 0.0-5.0% versus 1.7-6.6%
In plain English: Co-administration of flibanserin 100 mg with varying doses of ethanol resulted in few AEs of special interest, with no notable alcohol dose response.
Simon JA, Clayton AH, Parish SJ, Apfel SC, Millheiser L · The Journal of Sexual Medicine (2020)
Randomized, double-blind, single-dose crossover study in 96 healthy premenopausal women (mean age 31) receiving flibanserin 100 mg or placebo with ethanol 0.2, 0.4 or 0.6 g/kg, or flibanserin alone, using a deliberate worst-case design of morning dosing with alcohol consumed within 10 minutes
Dizziness occurred in 39.8% (ethanol 0.6 g/kg), 34.1% (0.4 g/kg) and 27.4% (0.2 g/kg) with flibanserin, versus 31.1% for flibanserin without ethanol — no clear alcohol dose-response
No instances of syncope were observed and, on available vital-signs data, no effect of ethanol concentration on orthostatic blood pressure or hypotension
In plain English: Flibanserin, initially developed as an antidepressant, is the first medication approved by the U.S. Food and Drug Administration (FDA) for the management of hypoactive sexual desire disorder (HSDD) in premenopausal women.
Flibanserin is available as a 100 mg oral tablet administered once daily at bedtime; bedtime dosing minimises the risk of hypotension, syncope, accidental injury or CNS depression during waking hours
Contraindicated with strong or moderate CYP3A4 inhibitors and in hepatic impairment, due to the heightened risk of syncope and hypotension; simultaneous alcohol use is no longer an outright contraindication but is carried in a boxed warning in the latest FDA-approved labelling
Alcohol should be avoided within 2 hours of taking flibanserin if 1 or 2 drinks have been consumed; if 3 or more drinks have been consumed, the dose should be skipped. In 2019 the FDA replaced the original REMS with a medication-guide-only REMS, eliminating prescriber and pharmacist certification
12Animal2010
In plain English: Systemic administration of flibanserin to female rats differentially affects the monoamine systems of the brain. This may be the mechanistic underpinning of flibanserin's therapeutic efficacy in HSDD.
Allers KA, Dremencov E, Ceci A, Flik G, Ferger B, Cremers TI, Ittrich C, Sommer B · The Journal of Sexual Medicine (2010)
Microdialysis study in female Wistar rats with probes in the medial prefrontal cortex, nucleus accumbens and hypothalamic medial preoptic area
Acute flibanserin decreased serotonin and increased norepinephrine in all tested areas; dopamine increased in the medial prefrontal cortex and medial preoptic area but not the nucleus accumbens
Repeated administration raised basal norepinephrine in the medial prefrontal cortex and nucleus accumbens and basal dopamine in the medial prefrontal cortex; basal serotonin was unchanged, as were glutamate and GABA
In plain English: The use of flibanserin is limited by modest efficacy and the risk of severe hypotension and syncope (fainting). This risk is increased by alcohol, and by medications that inhibit CYP3A4 (the primary enzyme that metabolizes flibanserin).
Dean L · Medical Genetics Summaries [Internet], NCBI Bookshelf (2012)
Flibanserin acts on central serotonin receptors and was initially developed as an antidepressant; it was not effective for depression but did appear to increase sex drive
CYP3A4 is the primary enzyme metabolising flibanserin; moderate and strong CYP3A4 inhibitors — including several antibiotics, antiviral agents, cardiac drugs, and grapefruit juice — raise exposure and are contraindicated
CYP2C19 also contributes to metabolism; poor metabolisers have higher flibanserin exposure and, per the FDA label, potentially increased risk of hypotension, syncope and CNS depression, though the label provides no alternative dosing for them