flibanserin
Regulatory sources consulted
Approved indications
- Acquired, generalized hypoactive sexual desire disorder in women younger than 65 years, causing marked distress and not explained by another condition, the relationship, or a medicine.
Contraindications
Absolute
- Concomitant use of moderate or strong CYP3A4 inhibitors.
- Any degree of hepatic impairment.
- Known hypersensitivity to flibanserin or its components.
Clinical warnings
- Boxed warning · Boxed warning: alcohol close to the dose increases the risk of severe hypotension and syncope. Wait at least 2 hours after 1–2 drinks before the dose; skip it after 3 or more, and avoid alcohol until the next day. — DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394
- Major warning · It may cause CNS depression, somnolence, sedation, hypotension, and syncope. Avoid driving or alertness-dependent tasks for at least 6 hours after the dose and until the response is known. — DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394
Drug interactions
- HighAlcohol
Mechanism: It increases the risk of hypotension, syncope, and CNS depression.
Recommendation: Strictly follow the label alcohol intervals.
DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394
- HighModerate or strong CYP3A4 inhibitors
Mechanism: They increase exposure and the risk of hypotension and syncope.
Recommendation: Contraindicated combination; follow the label washout intervals.
DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394
- HighCentral nervous system depressants
Mechanism: They may increase somnolence and sedation.
Recommendation: Assess the combination and use extra alertness precautions.
DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394
- ModerateCYP3A4 inducers such as carbamazepine, phenobarbital, phenytoin, rifamycins, or St John’s wort
Mechanism: They substantially decrease flibanserin exposure.
Recommendation: Concomitant use is not recommended.
DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394
- HighDigoxin or other narrow-therapeutic-index P-gp substrates
Mechanism: Flibanserin may increase digoxin concentration and cause toxicity.
Recommendation: Increase monitoring of P-gp substrate concentrations, especially digoxin.
DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394
- HighStrong CYP2C19 inhibitors or CYP2C19 poor metabolizers
Mechanism: They increase flibanserin exposure and the risk of hypotension, syncope, and CNS depression.
Recommendation: Discuss use of strong inhibitors when prescribing and increase adverse-reaction monitoring in poor metabolizers.
DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394
Adverse events
Common (≥1%)
Dizziness · Somnolence · Nausea · Fatigue · Insomnia · Dry mouth
Rare but serious
Severe hypotension or syncope · Anaphylaxis or angioedema
Pregnancy and lactation
There are no adequate pregnancy studies; fetal toxicity occurred in animals with substantial maternal toxicity. Use while breastfeeding is not recommended: it is excreted in animal milk and, because of the potential for serious adverse reactions in the infant, a decision must be made whether to discontinue breastfeeding or the medicine.
Recent literature (PubMed)
Nearly half of women in the United States report problems with sexual function. Many health care providers do not ask about sexual concerns during routine clinical encounters because of personal discomfort, lack of familiarity with treatment, or the belief that they lack adequate time to address this complex issue. This may be especially true for hypoactive sexual desire disorder (HSDD), the most commonly identified sexual problem among women. HSDD is characterized by a deficiency of sexual thoughts, feelings, or receptiveness to sexual stimulation that has been present for at least 6 months, causes personal distress, and is not due to another medical condition. This is an up-to-date overview of HSDD for clinicians, discussing its physiology, assessment, diagnosis, and treatment strategies. Although a definitive physiology of HSDD is still unknown, multiple hormones and neurotransmitters likely participate in a dual-control model to balance excitation and inhibition of sexual desire. For assessment and diagnosis, validated screening tools are discussed, and the importance of a biopsychosocial assessment is emphasized, with guidance on how this can be implemented in clinical encounters. The 2 recently approved medications for HSDD, flibanserin and bremelanotide, are reviewed as well as off-label treatments. Overall, HSDD represents a common yet likely underrecognized disorder that midwives and other health care providers who care for women across the life span are in a unique position to address.
To conduct a systematic review and meta-analysis of treatments for female sexual desire, arousal, and orgasmic dysfunction in patients without sexual pain conditions. MEDLINE, Embase, Web of Science, Cochrane Library, PsycINFO, and ClinicalTrials.gov. Following the initial search in December 2024, a total of 8994 abstracts were screened, 278 full-text articles were reviewed, and 36 studies met criteria for data abstraction including a patient population with female sexual dysfunction (FSD) of desire, arousal, and/or orgasm (DAO) and outcome measures including the Female Sexual Function Index (FSFI), its DAO subscales, and the Female Sexual Distress Scale (FSDS). Studies including patients with sexual pain conditions were excluded. Two reviewers independently conducted each phase. Of the 36 studies, 26 were RCTs and 10 were single-arm trials. Ten studies evaluated cognitive behavioral therapy (CBT), 24 investigated medication therapy, and 2 investigated devices. Meta-analyses were conducted for mindfulness-based CBT, flibanserin, and bremelanotide. Mindfulness-based CBT significantly improved total FSFI and subscales of desire, arousal, and orgasm. Conversely, flibanserin improved total FSFI and desire while bremelanotide improved total FSFI and its desire and arousal subscales. No studies directly compared CBT to pharmacotherapy. In this systematic review of treatments of females with sexual DAO dysfunctions without pain, we found that CBT improves DAO; flibanserin improves desire; and bremelanotide improves both desire and arousal; and all 3 treatments reduce distress. Our findings align with previous literature and expand upon it to include multiple treatment modalities. This broader perspective offers a starting point for clinicians, including gynecologists, who frequently serve as the first point of care for FSD. Conclusions regarding most other treatments could not be drawn due to limited numbers of studies of FSD excluding pain, heterogeneous terminology for D
Female sexual dysfunction (FSD) comprises multiple overlapping sexual disorders with a multifaceted cause within the frame of the biopsychosocial model. Health care providers can screen for FSD according to their level of expertise and deliver at least basic counseling before eventually referring to sexual medicine specialists for specific care. The therapeutic algorithm comprises a multidisciplinary approach, including pharmacologic and nonpharmacologic management. Flibanserin and bremelanotide are psychoactive agents indicated for the treatment of generalized acquired hypoactive sexual desire disorder (HSDD) in premenopausal women, whereas transdermal testosterone is effective on HSDD in postmenopausal women. Menopause hormone therapy (systemic and local) is the mainstay for individualized management of women at midlife.
This review article discusses the controversy in the DSM-5 conceptualization and diagnostic criteria for female sexual dysfunction (FSD). An overview of recent studies on available treatments for hypoactive sexual desire disorder (HSDD), female sexual arousal disorder (FSAD), and genitopelvic pain/penetration disorder (GPPD) is provided. Include delineation of the process of care for pre- and postmenopausal women with HSDD; release of global position statement on testosterone therapy in women; updates on efficacy and safety of vaginal estrogen for genitourinary syndrome of menopause and bremelanotide for HSDD; removal of flibanserin alcohol REMS; and development of new technology to enhance bioavailability and brain delivery of treatments. The DSM-5 revision combining HSDD and FSAD into one diagnostic category is a less accurate characterization of these separate disorders and may hinder access to demonstrated effective treatments for the women with these conditions. There are a wide range of pharmacological, other physiological, and psychological treatment options available for women with FSD, which can be offered based on their specific symptoms, potential benefits/risks, and preferences.