Effects of flibanserin: A Synthesis of Findings from 24 Studies

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Original Abstract of the Article

Major Research Findings

Flibanserin is a medication approved for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Several clinical trials have demonstrated that flibanserin can improve sexual desire and satisfaction in women with HSDD. 15 conducted a pooled analysis of three pivotal clinical trials and found that flibanserin significantly increased the number of satisfying sexual events (SSEs), improved scores on the Female Sexual Function Index desire domain (FSFI-d), and decreased scores on the Female Sexual Distress Scale-Revised Item 13 (FSDS-R-13) compared to placebo. Additionally, 13 discovered that flibanserin treatment was associated with statistically significant weight loss compared to placebo. 21 conducted an open-label safety study and concluded that flibanserin was generally safe for both premenopausal and naturally postmenopausal women with HSDD.

Several studies have explored the safety of flibanserin in conjunction with alcohol consumption. 9 investigated the safety of flibanserin in conjunction with alcohol in healthy premenopausal women and reported that high alcohol intake may reduce the effectiveness of flibanserin. 11 studied the relationship between the timing of flibanserin administration and alcohol intake and suggested that bedtime dosing might reduce the risk of interactions with alcohol. 12 further corroborated these findings, concluding that the risk of interactions with alcohol was minimal when flibanserin was administered at bedtime.

Benefits and Risks

Benefits Summary

Flibanserin holds promise as a treatment for HSDD in premenopausal women, potentially increasing sexual desire and enhancing satisfaction. 15 demonstrated that flibanserin significantly increased sexual satisfaction, improved FSFI-d scores, and reduced FSDS-R-13 scores compared to placebo. Furthermore, flibanserin might contribute to weight loss, as indicated by 13 .

Risks Summary

Flibanserin may cause side effects such as dizziness and drowsiness. 15 reported dizziness and drowsiness in over 10% of patients. Additionally, flibanserin interacts with alcohol, potentially increasing the risk of low blood pressure and fainting. 9 concluded that excessive alcohol intake could negatively affect the effectiveness of flibanserin.

Comparison of Studies

Commonalities in Research

Multiple clinical trials have consistently demonstrated that flibanserin effectively increases sexual satisfaction, improves FSFI-d scores, and reduces FSDS-R-13 scores in premenopausal women with HSDD. 15

Differences in Research

Research on flibanserin exhibits variations in participant demographics, including age and HSDD duration, as well as alcohol consumption levels and the timing of flibanserin administration. Some studies have suggested a link between flibanserin and weight loss, while others have not. 13

Consistency and Discrepancies in Results

While multiple clinical trials have indicated the effectiveness of flibanserin in treating HSDD in premenopausal women, some studies have highlighted the potential risks associated with alcohol interaction. 9 The relationship between the timing of flibanserin administration and alcohol intake requires further research. 11

Considerations for Real-World Application

While flibanserin holds promise as a treatment option for HSDD in premenopausal women, the risk of interactions with alcohol necessitates caution. 9 Flibanserin may cause side effects such as dizziness and drowsiness. To mitigate these potential effects, it is recommended to take the medication at bedtime. 15

Limitations of Current Research

Current research on flibanserin is limited to premenopausal women, necessitating further investigation into its effects and safety in postmenopausal women. Additional research is crucial to thoroughly understand the interactions between flibanserin and other medications. Long-term effects and safety of flibanserin require further study.

Future Research Directions

Future research on flibanserin should delve deeper into its effects and safety in postmenopausal women, explore its interactions with other medications, and assess its long-term effects and safety. The relationship between the timing of flibanserin administration and alcohol intake merits further exploration. Elucidating the mechanisms of action of flibanserin could pave the way for the development of safer and more effective treatment options.

Conclusion

Flibanserin demonstrates potential as a treatment for HSDD in premenopausal women, offering the possibility of enhancing sexual desire and satisfaction. 15 However, it is crucial to be aware of the risk of alcohol interactions and other potential side effects. 9 15 If considering flibanserin, it is essential to follow your physician's instructions carefully and take the medication responsibly.

Literature analysis of 24 papers
Positive Content
18
Neutral Content
3
Negative Content
3
Article Type
3
1
0
10
24
1.

A Different Perspective on the Characterization of a New Degradation Product of Flibanserin With HPLC-DAD-ESI-IT-TOF-MSn and Its Pharmaceutical Formulation Analysis With Inter-Laboratory Comparison.

Author: GevenAysun, ÖzcanSaniye, LeventSerkan, CanNafiz Öncü

Degradation product

A new and fully validated HPLC method for analysis of flibanserin (FLB) in pharmaceutical formulations was developed. A novel FLB degradation product was identified and characterized using HPLC-DAD-ESI-IT-TOF-MS3.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

5.

Management of hypoactive sexual desire disorder in transgender women: a guide for clinicians.

Author: CocchettiCarlotta, RistoriJiska, MazzoliFrancesca, VignozziLinda, MaggiMario, FisherAlessandra Daphne

HSDD treatment
HSDD
transgender women

Hypoactive sexual desire disorder (HSDD) is common among transgender women. This narrative review explores evidence-based treatment options for HSDD in transgender women, including sex therapy, central nervous system-active medications like flibanserin, bremelanotide, bupropion, and buspirone, and transdermal testosterone.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

6.

Optimized Nanostructured Lipid Carriers Integrated into In Situ Nasal Gel for Enhancing Brain Delivery of Flibanserin.

Author: FahmyUsama A, AhmedOsama A A, Badr-EldinShaimaa M, AldawsariHibah M, OkbazghiSolomon Z, AwanZuhier A, BakhrebahMuhammed A, AlomaryMohammad N, AbdulaalWesam H, MedinaCarlos, AlhakamyNabil A

Enhanced drug delivery
Nose-to-brain delivery

This work investigated the potential of using nanostructured lipid carriers (NLCs) to enhance nose-to-brain delivery of flibanserin, a serotonergic agent used for treating hypoactive sexual desire disorder.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Retracted PublicationCases where a publication has been formally withdrawn due to the discovery of serious errors or misconduct.

Language : English

7.

Application of Nanopharmaceutics for Flibanserin Brain Delivery Augmentation Via the Nasal Route.

Author: AhmedOsama A A, FahmyUsama A, Badr-EldinShaimaa M, AldawsariHibah M, AwanZuhier A, AsfourHani Z, KammounAhmed K, CarusoGiuseppe, CaraciFilippo, AlfarsiAnas, Al-GhamdiRaniyah A, Al-GhamdiRawan A, AlhakamyNabil A

Enhanced brain delivery
Improved bioavailability

This research developed an optimized flibanserin-loaded transfersome intranasal hydrogel, aiming to improve the bioavailability and brain delivery of flibanserin, a nonhormonal medicine used to treat hypoactive sexual desire disorder in females.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

8.

Evaluation of safety for flibanserin.

Author: ClaytonAnita H, BrownLouise, KimNoel N

Effective treatment of HSDD
Well-tolerated
Drug interactions
Hypotension
Sedation

This review summarizes flibanserin's pharmacokinetics, mechanism of action, and safety data for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

9.

Effects of Alcohol Administered With Flibanserin in Healthy Premenopausal Women: A Randomized, Double-Blind, Single-Dose Crossover Study.

Author: SimonJames A, ClaytonAnita H, ParishSharon J, ApfelStuart C, MillheiserLeah

Dizziness
Flibanserin

Co-administration of flibanserin with varying doses of ethanol did not have an additive effect on the adverse event profile of flibanserin in premenopausal women.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

Technological prospection: patents mapping involving compounds for the treatment of L-DOPA-induced dyskinesias.

Author: BarrosoSheilla Da Silva, LopesLorenna Emília Sena, SantosKlebson Silva, GomesMargarete Zanardo

Treat L-DOPA dyskinesias

Parkinson's disease (PD) is a debilitating disorder caused by the loss of dopamine-producing neurons in the brain. Levodopa (L-DOPA) is a common treatment for PD but can cause abnormal involuntary movements (AIMs). This review examines patents related to alternative treatments for L-DOPA-induced dyskinesias (LIDs), focusing on compounds that target the serotonergic system.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

11.

Effects of Timing of Flibanserin Administration Relative to Alcohol Intake in Healthy Premenopausal Women: A Randomized, Double-Blind, Crossover Study.

Author: SimonJames A, ClaytonAnita H, KingsbergSheryl A, ParishSharon J, KimNoel N, MillheiserLeah

Treats sexual desire disorder
Hypotension risk
Sedation risk
Syncope risk

Flibanserin is approved for treating acquired, generalized, hypoactive sexual desire disorder in premenopausal women. Sedation is a common side effect, and while infrequent, hypotension and syncope are safety concerns due to potential interactions with alcohol.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

12.

Safety and Tolerability of Evening Ethanol Consumption and Bedtime Administration of Flibanserin in Healthy Premenopausal Female Subjects.

Author: MillheiserLeah, ClaytonAnita H, ParishSharon J, KingsbergSheryl A, KimNoel N, SimonJames A

Treats sexual desire disorder
Hypotension risk
Syncope risk

This study examines the safety of flibanserin, a treatment for hypoactive sexual desire disorder, when used with alcohol, specifically focusing on the recommended bedtime dosing.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

13.

Weight Loss in Women Taking Flibanserin for Hypoactive Sexual Desire Disorder (HSDD): Insights Into Potential Mechanisms.

Author: SimonJames A, KingsbergSheryl A, GoldsteinIrwin, KimNoel N, HakimBrittany, MillheiserLeah

Weight loss

This post hoc analysis of clinical trial data found that flibanserin treatment was associated with statistically significant weight loss relative to placebo.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

14.

Evaluation of Flibanserin Safety: Comparison with Other Serotonergic Medications.

Author: KingsbergSheryl A, McElroySusan L, ClaytonAnita H

Hypoactive sexual desire disorder treatment
Hypotension
Sedation
Syncope

Flibanserin is a drug used to treat low sexual desire in women. It can cause low blood pressure, fainting, and drowsiness, especially when used with alcohol.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

16.

Trazodone in Sexual Medicine: Underused and Overdosed?

Author: PykeRobert E

HSDD treatment
CNS depression
Drug interactions

Flibanserin and trazodone, medications for hypoactive sexual desire disorder, have limited use due to concerns about central nervous system depression and interactions.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

17.

Female Sexual Dysfunction and the Placebo Effect: A Meta-analysis.

Author: WeinbergerJames M, HoumanJustin, CaronAshley T, PatelDevin N, BaskinAvi S, AckermanA Lenore, EilberKaryn S, AngerJennifer T

Placebo effect

A meta-analysis of 8 randomized controlled trials revealed that 67.7% of the treatment effect for female sexual dysfunction was accounted for by the placebo effect. Current treatments for female sexual dysfunction are minimally superior to placebo, highlighting the need for more efficacious treatments.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.

Language : English

19.

Effect Size in Efficacy Trials of Women With Decreased Sexual Desire.

Author: PykeRobert E, ClaytonAnita H

Effective CBT
Effective MMT

Some reviewers judge the effect size for medications vs placebo small, but substantial for CBT or MMT vs wait list. However, comparisons of the effect sizes for the active intervention, control treatment, and their differential are lacking.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

20.

Sex Differences in the Treatment of Sexual Dysfunction.

Author: HarshVeronica, ClaytonAnita H

Sexual dysfunction

The treatment of sexual dysfunction in men and women differs due to neurobiological differences, hormonal effects, and differences in epidemiology, medical comorbidities, and medication interference.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

21.

Flibanserin for Hypoactive Sexual Desire Disorder: An Open-Label Safety Study.

Author: SimonJames A, DerogatisLeonard, PortmanDavid, BrownLouise, YuanJames, KisslingRobert

Reduced distress
Dizziness
Insomnia
Nausea
Somnolence

Flibanserin was generally safe and well tolerated for the treatment of hypoactive sexual desire disorder in premenopausal and naturally postmenopausal women. The most common adverse effects were dizziness, somnolence, insomnia, and nausea.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

22.

Women's Sexual Health and Reproductive Function After SCI.

Author: CourtoisFrédérique, AlexanderMarcalee, McLainAmie B Jackson

Improved sexual function
Pregnancy success
SCI complications

Women with spinal cord injuries (SCI) can achieve positive sexual and reproductive health with appropriate education and treatment. They can use psychogenic or reflexogenic stimulation to obtain sexual pleasure and orgasm. Pregnancy is possible with younger age at the time of injury and pregnancy being predictors of successful pregnancy.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

23.

Safety of Flibanserin in Women Treated With Antidepressants: A Randomized, Placebo-Controlled Study.

Author: ClaytonAnita H, CroftHarry A, YuanJames, BrownLouise, KisslingRobert

Remission of anxiety
Remission of depression
Safe flibanserin
Back pain
Dizziness
Dry mouth
Insomnia

The study found that flibanserin 100 mg qhs was generally safe and well tolerated in premenopausal women with mild or remitted depression taking a serotonergic antidepressant.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

24.

Recent Developments in Psychopharmaceutical Approaches to Treating Female Sexual Interest and Arousal Disorder.

Author: BothStephanie

FSIAD Treatment

The study found that the observed effects of flibanserin and other new drugs under development seem limited in terms of clinical significance.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

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