FDA approves flibanserin for hypoactive sexual desire disorder in postmenopausal women

In postmenopausal women, the superiority of flibanserin 100 mg over placebo in increasing the number of SSE was also observed (MD 0.37, 95% CI [0.14, 0.61], P = .002, I2 = 0% [not important heterogeneity], high certainty of evidence) (Fig. Sensitivity analysis performed by omitting each trial to search for the sources of heterogeneity of flibanserin 100 mg on SSE in premenopausal women showed that none of the trials could substantially influence the pooled effect. Forest plot highlighting the change from baseline in (A) SSE in premenopausal women, Flibanserin 100 mg vs Placebo; (B) SSE in premenopausal women, Flibanserin 50 mg vs Placebo; (C) SSE in postmenopausal women, Flibanserin 100 mg vs Placebo; (D) e-Diary sexual desire score in premenopausal women, Flibanserin 100 mg vs Placebo; (E) e-Diary sexual desire score in premenopausal women, Flibanserin 50 mg vs Placebo. 3.5.2.

• Flibanserin is used to treat premenopausal women with hypoactive sexual desire disorder (HSDD).
• It is marketed under the brand name Addyi.
• Flibanserin works by modulating serotonin and dopamine levels in the brain.
• It was approved by the FDA in 2015 for HSDD treatment.
• Common side effects include dizziness, nausea, and fatigue.
• Flibanserin is usually taken once daily at bedtime.
• It has contraindications with alcohol due to risk of severe hypotension.
• Patients should avoid alcohol while using flibanserin.
• It is a non-hormonal medication specifically for sexual desire issues.

eDiary sexual desire score Flibanserin 100 mg outperformed placebo in improving sexual desire score measured using eDiary (MD 1.71, 95% CI [0.43, 2.98], P = .009, I2 = 0% [not important heterogeneity], moderate certainty of evidence) (Fig.

Such benefit was not observed with flibanserin 50 mg over placebo (MD 0.67, 95% CI [−0.71, 2.05], P = .34, I2 = 0% [not important heterogeneity]) (Fig. Effect of flibanserin on secondary efficacy outcomes Compared to placebo, greater increments in FSFI desire domain scores were observed in premenopausal women with flibanserin 100 mg (MD 0.30, 95% CI [0.29, 0.31], P < .00001, I2 = 0% [not important heterogeneity]) (Fig.

A similar benefit was observed with flibanserin 100 mg in postmenopausal women (MD 0.25, 95% CI [0.06, 0.44], P = .01, I2 = 0% [not important heterogeneity]) (Fig. Forest plot highlighting the change from baseline in (A) FSFI-d score in premenopausal women, Flibanserin 100 mg vs Placebo; (B) FSFI-d score in premenopausal women, Flibanserin 50 mg vs Placebo; (C) FSFI-d score in postmenopausal women, Flibanserin 100 mg vs Placebo; (D) FSFI total score in premenopausal women, Flibanserin 100 mg vs Placebo; (E) FSFI total score in premenopausal women, Flibanserin 50 mg vs Placebo; (F) FSFI total score in postmenopausal women, Flibanserin 100 mg vs Placebo. Flibanserin 100 mg was better than placebo in improving FSFI total scores in both premenopausal (MD 2.51, 95% CI [1.47, 3.55], P < .00001, I2 = 90% [high heterogeneity]) (Fig. 3D), and postmenopausal women (MD 1.42, 95% CI [0.56, 2.29], P = .001, I2 = 0% [not important heterogeneity]) (Fig. Such a beneficial effect was not observed with flibanserin 50 mg dose in premenopausal women (MD 0.74, 95% CI [−0.52, 1.99], P = .25, I2 = 80% [high heterogeneity]) (Fig. FSDS-R item 13 and total scores Flibanserin 100 mg also outperformed placebo in reducing FSDS-R Item 13 scores in both premenopausal (MD −0.30, 95% CI [−0.31, −0.29], P < .00001, I2 = 0% [not important heterogeneity]) (Fig. 4A), and postmenopausal women (MD −0.20, 95% CI [−0.39, −0.01], P = .04, I2 = 0% [not important heterogeneity]) (Fig. The efficacy of flibanserin 50 mg in reducing FSDS-R Item 13 scores in premenopausal women was similar to placebo (MD −0.10, 95% CI [−0.29, 0.09], P = .31, I2 = 0% [not important heterogeneity]) (Fig. Forest plot highlighting the change from baseline in (A) FSDS-R Item 13 score in premenopausal women, Flibanserin 100 mg vs Placebo; (B) FSDS-R Item 13 score in premenopausal women, Flibanserin 50 mg vs Placebo; (C) FSDS-R Item 13 score in postmenopausal women, Flibanserin 100 mg vs Placebo; (D) FSDS-R total score in premenopausal women, Flibanserin 100 mg vs Placebo; (E) FSDS-R total score in premenopausal women, Flibanserin 50 mg vs Placebo; (F) FSDS-R total score in postmenopausal women, Flibanserin 100 mg vs Placebo.

In premenopausal women, flibanserin was superior to placebo in reducing FSDS-R total scores at both 100 mg (MD −3.30, 95% CI [−3.37, −3.23], P < .00001, I2 = 0% [not important heterogeneity]) (Fig.

Pharmacist tips for Addyi (flibanserin)

[27] The result of the present meta-analysis is within the range mentioned by the FDA for premenopausal women. The efficacy of 50 mg of flibanserin is far less in the same population. The drug has minimal efficacy in postmenopausal women and is not yet approved for treating HSDD in them. In addition, a mean of 1.71 eDiary sexual desire score was increased among the premenopausal women treated with flibanserin 100 mg; flibanserin at 50 mg daily doses was proven ineffective in this regard. Moreover, the FSFI desire domain score, which is extensively used as a measure of sexual desire in women, showed the superiority of flibanserin over placebo in both premenopausal (mean increase 0.30 for 100 mg and 0.25 for 50 mg) and postmenopausal women (0.25 for 100 mg). A similar benefit of flibanserin 100 mg over placebo was also observed in postmenopausal women (MD −2.42, 95% CI [−3.68, −1.16], P = .0002, I2 = 0% [not important heterogeneity]) (Fig. Postmenopausal women treated with flibanserin 100 mg showed a similar change in PGI-I score compared to those treated with placebo (MD −0.15, 95% CI [−0.44, 0.14], P = .32, I2 = 56% [moderate heterogeneity]) (Fig.

In premenopausal women, a higher number of subjects achieved improvements in the PGI-I score in the flibanserin 100 mg arm (OR 1.93, 95% CI [1.58, 2.36], P < .00001, I2 = 32% [mild heterogeneity]) (Fig. Forest plot highlighting the (A) Change from baseline in PGI-I score in postmenopausal women, Flibanserin 100 mg vs Placebo; (B) Proportions of premenopausal women with improvement in PGI-I score, Flibanserin 100 mg vs Placebo; (C) Proportions of premenopausal women with improvement in PGI-I score, Flibanserin 50 mg vs Placebo; (D) Proportions of premenopausal women responded positively at PBE, Flibanserin 100 mg vs Placebo; (E) Proportions of premenopausal women responded positively at PBE, Flibanserin 50 mg vs Placebo; (F) Proportions of postmenopausal women responded positively at PBE, Flibanserin 100 mg vs Placebo. The percentage of premenopausal women who responded positively (“yes”) when asked whether they had experienced a meaningful benefit from the study medication was higher in the flibanserin 100 mg arm (OR 1.76, 95% CI [1.34, 2.31], P < .0001, I2 = 59% [moderate heterogeneity]) (Fig. For the same outcome, flibanserin 100 mg was better than placebo in postmenopausal women (OR 1.54, 95% CI [1.24, 1.90], P < .0001, I2 = 0% [not important heterogeneity]) (Fig. The safety outcomes of flibanserin versus placebo are summarized in Table 3. The number of study subjects experiencing any AEs was higher in the flibanserin 100 mg arm (RR 1.37, 95% CI [1.14, 1.65], P = .009, I2 = 93% [high heterogeneity], very low certainty of evidence), and flibanserin 50 mg arm (RR 1.18, 95% CI [1.03, 1.36], P = .02, I2 = 72% [moderate heterogeneity]) (Fig. More study subjects on flibanserin 100 mg experienced drug-related AEs (RR 2.33, 95% CI [1.96, 2.76], P < .00001, I2 = 0% [not important heterogeneity]) and AEs leading to study discontinuation (RR 2.08, 95% CI [1.39, 3.10], P = .0003, I2 = 50% [moderate heterogeneity]) than those on placebo. Serious AEs and severe AEs were comparable between flibanserin and placebo groups. Table 3 - The results of safety outcomes of vardenafil hcl 10mg flibanserin vs placebo in the meta-analysis. More subjects taking flibanserin 100 mg (RR 3.95, 95% CI [2.40, 6.51], P < .00001, I2 = 70% [moderate heterogeneity], low certainty of evidence) and flibanserin 50 mg (RR 2.39, 95% CI [1.61, 3.55], P < .0001, I2 = 0% [not important heterogeneity]) experienced dizziness than those who took a placebo. Compared to the placebo group, a similar number of subjects in the flibanserin 100 mg and flibanserin 50 mg groups experienced headache. Fatigue (RR 1.91, 95% CI [1.30, 2.81], P = .01, I2 = 53% [moderate heterogeneity], low certainty of evidence), nausea (RR 2.37, 95% CI [1.69, 3.33], P < .000001, I2 = 54% [moderate heterogeneity], moderate certainty of evidence), somnolence (RR 4.04, 95% CI [3.15, 5.18], P < .000001, I2 = 0% [not important heterogeneity], moderate certainty of evidence), and insomnia (RR 1.69, 95% CI [1.09, 2.62], P = .02, I2 = 0% [not important heterogeneity], moderate certainty of evidence) were more frequent in the flibanserin 100 mg group than in the placebo group.

Macrocircuits and Sexual Interest and Desire

Forest plot highlighting the change from baseline in (A) FSDS-R Item 13 score in premenopausal women, Flibanserin 100 mg vs Placebo; (B) FSDS-R Item 13 score in premenopausal women, Flibanserin 50 mg vs Placebo; (C) FSDS-R Item 13 score in postmenopausal women, Flibanserin 100 mg vs Placebo; (D) FSDS-R total score in premenopausal women, Flibanserin 100 mg vs Placebo; (E) FSDS-R total score in premenopausal women, Flibanserin 50 mg vs Placebo; (F) FSDS-R total score in postmenopausal women, Flibanserin 100 mg vs Placebo. In premenopausal women, flibanserin was superior to placebo in reducing FSDS-R total scores at both 100 mg (MD −3.30, 95% CI [−3.37, −3.23], P < .00001, I2 = 0% [not important heterogeneity]) (Fig. A similar benefit of flibanserin 100 mg over placebo was also observed in postmenopausal women (MD −2.42, 95% CI [−3.68, −1.16], P = .0002, I2 = 0% [not important heterogeneity]) (Fig. Postmenopausal women treated with flibanserin 100 mg showed a similar change in PGI-I score compared to those treated with placebo (MD −0.15, 95% CI [−0.44, 0.14], P = .32, I2 = 56% [moderate heterogeneity]) (Fig. In premenopausal women, a higher number of subjects achieved improvements in the PGI-I score in the flibanserin 100 mg arm (OR 1.93, 95% CI [1.58, 2.36], P < .00001, I2 = 32% [mild heterogeneity]) (Fig.

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Forest plot highlighting the (A) Change from baseline in PGI-I score in postmenopausal women, Flibanserin 100 mg vs Placebo; (B) Proportions of premenopausal women with improvement in PGI-I score, Flibanserin 100 mg vs Placebo; (C) Proportions of premenopausal women with improvement in PGI-I score, Flibanserin 50 mg vs Placebo; (D) Proportions of premenopausal women responded positively at PBE, Flibanserin 100 mg vs Placebo; (E) Proportions of premenopausal women responded positively at PBE, Flibanserin 50 mg vs Placebo; (F) Proportions of postmenopausal women responded positively at PBE, Flibanserin 100 mg vs Placebo. The percentage of premenopausal women who responded positively (“yes”) when asked whether they had experienced a meaningful benefit from the study medication was higher in the flibanserin 100 mg arm (OR 1.76, 95% CI [1.34, 2.31], P < .0001, I2 = 59% [moderate heterogeneity]) (Fig. For the same outcome, flibanserin 100 mg was better than placebo in postmenopausal women (OR 1.54, 95% CI [1.24, 1.90], P < .0001, I2 = 0% [not important heterogeneity]) (Fig. The safety outcomes of flibanserin versus placebo are summarized in Table 3. The number of study subjects experiencing any AEs was higher in the flibanserin 100 mg arm (RR 1.37, 95% CI [1.14, 1.65], P = .009, I2 = 93% [high heterogeneity], very low certainty of evidence), and flibanserin 50 mg arm (RR 1.18, 95% CI [1.03, 1.36], P = .02, I2 = 72% [moderate heterogeneity]) (Fig.

Features and Benefits

More study subjects on flibanserin 100 mg experienced drug-related AEs (RR 2.33, 95% CI [1.96, 2.76], P < .00001, I2 = 0% [not important heterogeneity]) and AEs leading to study discontinuation (RR 2.08, 95% CI [1.39, 3.10], P = .0003, I2 = 50% [moderate heterogeneity]) than those on placebo. Serious AEs and severe AEs were comparable between flibanserin and placebo groups. Table 3 - The results of safety outcomes of vardenafil hcl 10mg flibanserin vs placebo in the meta-analysis. More subjects taking flibanserin 100 mg (RR 3.95, 95% CI [2.40, 6.51], P < .00001, I2 = 70% [moderate heterogeneity], low certainty of evidence) and flibanserin 50 mg (RR 2.39, 95% CI [1.61, 3.55], P < .0001, I2 = 0% [not important heterogeneity]) experienced dizziness than those who took a placebo. Compared to the placebo group, a similar number of subjects in the flibanserin 100 mg and flibanserin 50 mg groups experienced headache. Subjects in the flibanserin 50 mg group also exhibited a higher risk of somnolence than the placebo group (RR 2.08, 95% CI [1.30, 3.35], P = .002, I2 = 34% [mild heterogeneity]). The present meta-analysis incorporated the results of RCTs of flibanserin in HSDD that are available to date. It highlights the efficacy and adverse events of flibanserin compared to a placebo used to manage HSDD in pre-and postmenopausal women. Flibanserin is more effective than placebo in treating HSDD, although its use is associated with higher risks of AEs. US FDA approved flibanserin in August 2015 as the first medication to treat acquired, generalized HSDD in premenopausal women. [27] Flibanserin is a non-hormonal oral medicine that acts on the brain to increase sexual desire. The mechanism by which flibanserin improves sexual desire and related distress is not known; this may be attributed to its high affinity for 5-HT1A and 5-HT2A receptors, displaying agonist activity on 5-HT1A and antagonist on 5-HT2A, resulting in lowering of serotonin in the brain as well as an effect on increasing norepinephrine and dopamine neurotransmitters.

• Reporting of adverse events is encouraged through the FDA MedWatch program.
• Healthcare providers should report syncope, severe hypotension, or liver injury.
• Post-marketing surveillance is critical for understanding rare, long-term risks.
• Drug utilization reviews track prescribing patterns and potential misuse.
• In case of suspected pregnancy, patients should contact their doctor immediately.
• Animal studies showed developmental toxicity at doses much higher than human dose.
• Lactation studies in animals showed excretion in milk; human data are lacking.
• Decision to breastfeed while on flibanserin requires weighing potential risks.
• The benefit for an individual patient must justify the potential risk to a fetus/infant.

Serotonin exerts an inhibitory influence on sexual activity by reducing dopamine release in the prefrontal cerebral cortex. Both dopamine and norepinephrine are essential components in the process of sexual excitation. Norepinephrine serves as a stimulant in sexual arousal, while dopamine contributes to the enhancement of desire.

Brand names

In postmenopausal women, the superiority of flibanserin 100 mg over placebo in increasing the number of SSE was also observed (MD 0.37, 95% CI [0.14, 0.61], P = .002, I2 = 0% [not important heterogeneity], high certainty of evidence) (Fig. Sensitivity analysis performed by omitting each trial to search for the sources of heterogeneity of flibanserin 100 mg on SSE in premenopausal women showed that none of the trials could substantially influence the pooled effect. Forest plot highlighting the change from baseline in (A) SSE in premenopausal women, Flibanserin 100 mg vs Placebo; (B) SSE in premenopausal women, Flibanserin 50 mg vs Placebo; (C) SSE in postmenopausal women, Flibanserin 100 mg vs Placebo; (D) e-Diary sexual desire score in premenopausal women, Flibanserin 100 mg vs Placebo; (E) e-Diary sexual desire score in premenopausal women, Flibanserin 50 mg vs Placebo. 3.5.2. eDiary sexual desire score Flibanserin 100 mg outperformed placebo in improving sexual desire score measured using eDiary (MD 1.71, 95% CI [0.43, 2.98], P = .009, I2 = 0% [not important heterogeneity], moderate certainty of evidence) (Fig.

What should I tell my healthcare provider before using Addyi?

Such benefit was not observed with flibanserin 50 mg over placebo (MD 0.67, 95% CI [−0.71, 2.05], P = .34, I2 = 0% [not important heterogeneity]) (Fig. Effect of flibanserin on secondary efficacy outcomes Compared to placebo, greater increments in FSFI desire domain scores were observed in premenopausal women with flibanserin 100 mg (MD 0.30, 95% CI [0.29, 0.31], P < .00001, I2 = 0% [not important heterogeneity]) (Fig. A similar benefit was observed with flibanserin 100 mg in postmenopausal women (MD 0.25, 95% CI [0.06, 0.44], P = .01, I2 = 0% [not important heterogeneity]) (Fig. Forest plot highlighting the change from baseline in (A) FSFI-d score in premenopausal women, Flibanserin 100 mg vs Placebo; (B) FSFI-d score in premenopausal women, Flibanserin 50 mg vs Placebo; (C) FSFI-d score in postmenopausal women, Flibanserin 100 mg vs Placebo; (D) FSFI total score in premenopausal women, Flibanserin 100 mg vs Placebo; (E) FSFI total score in premenopausal women, Flibanserin 50 mg vs Placebo; (F) FSFI total score in postmenopausal women, Flibanserin 100 mg vs Placebo. Flibanserin 100 mg was better than placebo in improving FSFI total scores in both premenopausal (MD 2.51, 95% CI [1.47, 3.55], P < .00001, I2 = 90% [high heterogeneity]) (Fig.

What are some side effects that I need to call my doctor about right away?

3D), and postmenopausal women (MD 1.42, 95% CI [0.56, 2.29], P = .001, I2 = 0% [not important heterogeneity]) (Fig. Such a beneficial effect was not observed with flibanserin 50 mg dose in premenopausal women (MD 0.74, 95% CI [−0.52, 1.99], P = .25, I2 = 80% [high heterogeneity]) (Fig. FSDS-R item 13 and total scores Flibanserin 100 mg also outperformed placebo in reducing FSDS-R Item 13 scores in both premenopausal (MD −0.30, 95% CI [−0.31, −0.29], P < .00001, I2 = 0% [not important heterogeneity]) (Fig. 4A), and postmenopausal women (MD −0.20, 95% CI [−0.39, −0.01], P = .04, I2 = 0% [not important heterogeneity]) (Fig. The efficacy of flibanserin 50 mg in reducing FSDS-R Item 13 scores in premenopausal women was similar to placebo (MD −0.10, 95% CI [−0.29, 0.09], P = .31, I2 = 0% [not important heterogeneity]) (Fig. By modulating these monoamines in patients with HSDD, flibanserin improves sexual desire and arousal.

Proper Use

Fatigue (RR 1.91, 95% CI [1.30, 2.81], P = .01, I2 = 53% [moderate heterogeneity], low certainty of evidence), nausea (RR 2.37, 95% CI [1.69, 3.33], P < .000001, I2 = 54% [moderate heterogeneity], moderate certainty of evidence), somnolence (RR 4.04, 95% CI [3.15, 5.18], P < .000001, I2 = 0% [not important heterogeneity], moderate certainty of evidence), and insomnia (RR 1.69, 95% CI [1.09, 2.62], P = .02, I2 = 0% [not important heterogeneity], moderate certainty of evidence) were more frequent in the flibanserin 100 mg group than in the placebo group. Subjects in the flibanserin 50 mg group also exhibited a higher risk of somnolence than the placebo group (RR 2.08, 95% CI [1.30, 3.35], P = .002, I2 = 34% [mild heterogeneity]). The present meta-analysis incorporated the results of RCTs of flibanserin in HSDD that are available to date. It highlights the efficacy and adverse events of flibanserin compared to a placebo used to manage HSDD in pre-and postmenopausal women. Flibanserin is more effective than placebo in treating HSDD, although its use is associated with higher risks of AEs.

Phonetic Name

US FDA approved flibanserin in August 2015 as the first medication to treat acquired, generalized HSDD in premenopausal women. [27] Flibanserin is a non-hormonal oral medicine that acts on the brain to increase sexual desire. The mechanism by which flibanserin improves sexual desire and related distress is not known; this may be attributed to its high affinity for 5-HT1A and 5-HT2A receptors, displaying agonist activity on 5-HT1A and antagonist on 5-HT2A, resulting in lowering of serotonin in the brain as well as an effect on increasing norepinephrine and dopamine neurotransmitters. Serotonin exerts an inhibitory influence on sexual activity by reducing dopamine release in the prefrontal cerebral cortex. Both dopamine and norepinephrine are essential components in the process of sexual excitation.

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Norepinephrine serves as a stimulant in sexual arousal, while dopamine contributes to the enhancement of desire. By modulating these monoamines in patients with HSDD, flibanserin improves sexual desire and arousal. In premenopausal women, flibanserin use was associated with 0.69 and 0.32 additional SSE per month at 100 and 50 mg daily doses; the number was 0.37 in postmenopausal women with flibanserin 100 mg. The improvement is not as robust as expected. US FDA report on the approval of flibanserin 100 mg mentioned that, on average, treatment with flibanserin 100 mg increased the number of satisfying sexual events by 0.5 to one additional event per month over placebo. In premenopausal women, flibanserin use was associated with 0.69 and 0.32 additional SSE per month at 100 and 50 mg daily doses; the number was 0.37 in postmenopausal women with flibanserin 100 mg. The improvement is not as robust as expected. US FDA report on the approval of flibanserin 100 mg mentioned that, on average, treatment with flibanserin 100 mg increased the number of satisfying sexual events by 0.5 to one additional event per month over placebo.

• The pharmacology of flibanserin demonstrates a complex serotonin-dopamine interplay.
• The medication is not a substitute for addressing relationship or psychological factors.
• It is essential to evaluate contraindications before prescribing flibanserin.
• The drug's societal impact includes increased awareness of female sexual health.
• Use during pregnancy is contraindicated due to unknown risks.
• Flibanserin requires healthcare provider supervision due to its safety profile.
• Its effectiveness varies, necessitating personalized treatment approaches.
• Ongoing studies seek to expand understanding of its benefits and risks.
• The medication represents a milestone in female sexual medicine advancements.

[27] The result of the present meta-analysis is within the range mentioned by the FDA for premenopausal women. The efficacy of 50 mg of flibanserin is far less in the same population. The drug has minimal efficacy in postmenopausal women and is not yet approved for treating HSDD in them. In addition, a mean of 1.71 eDiary sexual desire score was increased among the premenopausal women treated with flibanserin 100 mg; flibanserin at 50 mg daily doses was proven ineffective in this regard. Moreover, the FSFI desire domain score, which is extensively used as a measure of sexual desire in women, showed the superiority of flibanserin over placebo in both premenopausal (mean increase 0.30 for 100 mg and 0.25 for 50 mg) and postmenopausal women (0.25 for 100 mg).