Substance / Medication

Flibanserin

Overview

Active Ingredient
flibanserin
RxNorm CUI
1665509

Indications

ADDYI is indicated for the treatment of women less than 65 years of age with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to: Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation or partner. Limitations of Use • A co-existing

Labeler: Sprout Pharmaceuticals, Inc.Updated: 2025-12-22T00:00:00.000ZFull label on DailyMed

Boxed Warning

FDA Black Box Warning

Interaction with Alcohol Warnings and Precautions (5.1) [see The use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope]. Counsel patients to wait at least two hours after consuming one or two standard alcoholic drinks before taking ADDYI at bedtime or t

Contraindications

When this intervention should not be used

ADDYI is contraindicated in patients: • Boxed Warning Warnings and Precautions (5.2) [seeand] Using concomitant moderate or strong CYP3A4 inhibitors. • Boxed Warning Warnings and Precautions (5.5) [seeand] With hepatic impairment. • Adverse Reactions (6.2) [see] With known hypersensitivity to ADDYI

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Research Evidence

Published studies and systematic reviews

Sort:
Role of flibanserin in managing hypoactive sexual desire disorder in women: A systematic review and meta-analysis.
Kamrul-Hasan A B M, Hannan Mohammad Abdul, Alam Muhammad Shah et al. · Medicine (Baltimore) · 2024
PMID: 38905407Meta-AnalysisFull text (PMC)
Systematic Review and Meta-analysis of Flibanserin's Effects and Adverse Events in Women with Hypoactive Sexual Desire Disorder.
Saadat Seyed Hassan, Kabir Ali, Rahmani Khaled et al. · Curr Drug Metab · 2017
PMID: 27784209Meta-Analysis
Efficacy and Safety of Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Women: A Systematic Review and Meta-analysis.
Jaspers Loes, Feys Frederik, Bramer Wichor M et al. · JAMA Intern Med · 2016
PMID: 26927498Meta-Analysis
Efficacy and Safety of Flibanserin in Women with Hypoactive Sexual Desire Disorder: A Systematic Review and Meta-Analysis.
Gao Zhenli, Yang Diandong, Yu Luxin et al. · J Sex Med · 2015
PMID: 26745616Meta-Analysis
Effects of Alcohol Administered With Flibanserin in Healthy Premenopausal Women: A Randomized, Double-Blind, Single-Dose Crossover Study.
Simon James A, Clayton Anita H, Parish Sharon J et al. · J Sex Med · 2020
PMID: 31735618RCT
Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder: Results of the PLUMERIA Study.
Portman David J, Brown Louise, Yuan James et al. · J Sex Med · 2017
PMID: 28583342RCT
Next-day residual effects of flibanserin on simulated driving performance in premenopausal women.
Kay Gary G, Hochadel Thomas, Sicard Eric et al. · Hum Psychopharmacol · 2017
PMID: 28568608RCTFull text (PMC)
Efficacy of flibanserin in women with hypoactive sexual desire disorder: results from the BEGONIA trial.
Katz Molly, DeRogatis Leonard R, Ackerman Ronald et al. · J Sex Med · 2013
PMID: 23672269RCT

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type
Substance / Medication
Fully Specified Name
Flibanserin (substance)
SNOMED CT
715253002
UMLS CUI
C0754280
RxNorm CUI
1665509
Labeler
Sprout Pharmaceuticals, Inc.

Clinical Data

This intervention maps to 1 entities in the Ltrl knowledge graph.

1
Conditions
0
Biomarkers
0
Specialists
0
Symptoms

Data is sourced from SNOMED CT, UMLS, and the Ltrl clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.