flibanserin
Sources réglementaires consultées
Indications approuvées
- Trouble du désir sexuel hypoactif acquis et généralisé chez les femmes de moins de 65 ans, entraînant une détresse marquée et non expliqué par une autre affection, la relation ou un médicament.
Contre-indications
Absolues
- Utilisation concomitante d’inhibiteurs modérés ou puissants du CYP3A4.
- Tout degré d’insuffisance hépatique.
- Hypersensibilité connue à la flibansérine ou à ses composants.
Mises en garde cliniques
- Mise en garde encadrée · Avertissement encadré : l’alcool pris à proximité de la dose augmente le risque d’hypotension sévère et de syncope. Attendre au moins 2 heures après 1 à 2 verres ; omettre la dose après 3 verres ou plus et éviter l’alcool jusqu’au lendemain. — DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394
- Mise en garde majeure · Elle peut provoquer une dépression du système nerveux central, une somnolence, une sédation, une hypotension et une syncope. Éviter de conduire ou d’effectuer des tâches exigeant de la vigilance pendant au moins 6 heures après la dose et jusqu’à connaître la réponse. — DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394
Interactions médicamenteuses
- SévèreAlcool
Mécanisme: Il augmente le risque d’hypotension, de syncope et de dépression du système nerveux central.
Recommandation: Respecter strictement les intervalles avec l’alcool indiqués dans la notice.
DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394
- SévèreInhibiteurs modérés ou puissants du CYP3A4
Mécanisme: Ils augmentent l’exposition et le risque d’hypotension et de syncope.
Recommandation: Association contre-indiquée ; respecter les délais d’arrêt de la notice.
DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394
- SévèreDépresseurs du système nerveux central
Mécanisme: Ils peuvent majorer la somnolence et la sédation.
Recommandation: Évaluer l’association et renforcer les précautions liées à la vigilance.
DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394
- ModéréeInducteurs du CYP3A4 tels que carbamazépine, phénobarbital, phénytoïne, rifamycines ou millepertuis
Mécanisme: Ils réduisent fortement l’exposition à la flibansérine.
Recommandation: L’utilisation concomitante n’est pas recommandée.
DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394
- SévèreDigoxine ou autres substrats de la P-gp à marge thérapeutique étroite
Mécanisme: La flibansérine peut augmenter la concentration de digoxine et provoquer une toxicité.
Recommandation: Renforcer la surveillance des concentrations du substrat de la P-gp, en particulier de la digoxine.
DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394
- SévèreInhibiteurs puissants du CYP2C19 ou métaboliseurs lents du CYP2C19
Mécanisme: Ils augmentent l’exposition à la flibansérine et le risque d’hypotension, de syncope et de dépression du système nerveux central.
Recommandation: Discuter l’utilisation d’inhibiteurs puissants lors de la prescription et renforcer la surveillance des effets indésirables chez les métaboliseurs lents.
DailyMed, ADDYI, set ID 3819daf3-e935-2c53-c527-e1d57922f394https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394
Effets indésirables
Communs (≥1%)
Vertiges · Somnolence · Nausées · Fatigue · Insomnie · Sécheresse buccale
Rares mais graves
Hypotension sévère ou syncope · Anaphylaxie ou angio-œdème
Grossesse et allaitement
Il n’existe pas d’étude adéquate pendant la grossesse ; une toxicité fœtale est survenue chez l’animal en présence d’une toxicité maternelle importante. L’utilisation pendant l’allaitement n’est pas recommandée : le médicament passe dans le lait animal et, en raison du risque de réactions indésirables graves chez le nourrisson, il faut décider d’arrêter soit l’allaitement, soit le médicament.
Bibliographie récente (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.