flibanserin
Fuentes regulatorias consultadas
Indicaciones aprobadas
- Trastorno del deseo sexual hipoactivo adquirido y generalizado en mujeres menores de 65 años, con malestar marcado, no explicado por otra afección, la relación ni un medicamento.
Contraindicaciones
Absolutas
- Uso concomitante de inhibidores moderados o potentes de CYP3A4.
- Cualquier grado de insuficiencia hepática.
- Hipersensibilidad conocida a flibanserina o sus componentes.
Advertencias clínicas
- Advertencia destacada (boxed warning) · Advertencia destacada: el alcohol cercano a la dosis aumenta el riesgo de hipotensión grave y síncope. Esperar al menos 2 horas tras 1–2 bebidas antes de la dosis; omitirla si se consumieron 3 o más, y no beber hasta el día siguiente. — DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394
- Advertencia mayor · Puede causar depresión del sistema nervioso central, somnolencia, sedación, hipotensión y síncope. Evitar conducir o tareas de alerta durante al menos 6 horas después de la dosis y hasta conocer la respuesta. — DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394
Interacciones medicamentosas
- SeveraAlcohol
Mecanismo: Aumenta el riesgo de hipotensión, síncope y depresión del sistema nervioso central.
Recomendación: Aplicar estrictamente los intervalos de alcohol de la etiqueta.
DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394
- SeveraInhibidores moderados o potentes de CYP3A4
Mecanismo: Aumentan la exposición y el riesgo de hipotensión y síncope.
Recomendación: Combinación contraindicada; respetar los intervalos de suspensión de la etiqueta.
DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394
- SeveraDepresores del sistema nervioso central
Mecanismo: Pueden aumentar somnolencia y sedación.
Recomendación: Valorar la combinación y extremar precauciones de alerta.
DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394
- ModeradaInductores de CYP3A4, como carbamazepina, fenobarbital, fenitoína, rifamicinas o hierba de San Juan
Mecanismo: Reducen sustancialmente la exposición a flibanserina.
Recomendación: No se recomienda el uso concomitante.
DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394
- SeveraDigoxina u otros sustratos de P-gp con índice terapéutico estrecho
Mecanismo: Flibanserina puede aumentar la concentración de digoxina y causar toxicidad.
Recomendación: Aumentar la monitorización de las concentraciones del sustrato de P-gp, especialmente digoxina.
DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394
- SeveraInhibidores potentes de CYP2C19 o metabolizadores lentos de CYP2C19
Mecanismo: Aumentan la exposición a flibanserina y el riesgo de hipotensión, síncope y depresión del sistema nervioso central.
Recomendación: Comentar el uso de inhibidores potentes al prescribir y aumentar la vigilancia de reacciones adversas en metabolizadores lentos.
DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394
Eventos adversos
Comunes (≥1%)
Mareo · Somnolencia · Náuseas · Fatiga · Insomnio · Sequedad de boca
Raros pero graves
Hipotensión grave o síncope · Anafilaxia o angioedema
Embarazo y lactancia
No hay estudios adecuados en embarazo; en animales hubo toxicidad fetal con toxicidad materna importante. No se recomienda durante la lactancia: se excreta en leche animal y, por el potencial de reacciones adversas graves en el lactante, debe decidirse entre suspender la lactancia o suspender el fármaco.
Bibliografía reciente (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.