Tools for Practice Outils pour la pratique

#157 Flibanserin: Feeling frisky or falling over?

Does flibanserin improve sexual desire and the number of satisfying sexual episodes for women?

Flibanserin results in ~7improvement in desire and 0.4-1 additional “satisfying” sexual event per month. However, it is also associated with adverse events like dizziness or somnolence for one in 10-15 women. Concerns regarding hypotension, syncope, and interactions with commonly used drugs (particularly alcohol) are worrisome and require further research. 

CFPCLearn Logo

Reading Tools for Practice Article can earn you MainPro+ Credits

La lecture d'articles d'outils de pratique peut vous permettre de gagner des crédits MainPro+

Join Now S’inscrire maintenant

Already a CFPCLearn Member? Log in

Déjà abonné à CMFCApprendre? Ouvrir une session

  • Four double-blind randomized controlled trials of 1,581,1 880,2 and 1,0873 premenopausal women and 9494 postmenopausal women with Hypoactive Sexual Desire Disorder. Flibanserin (versus placebo) demonstrated: 
    • Statistically significant increase in “satisfying” sexual events: 0.4-1/28 days.3,4 
    • Nincrease daily sexual desire.1,2 
    • Increase in Female Sexual Function Index-Desire domain: 
      • 0.3-0.4 on scale of 1.2-6.0.1-4 
    • Number Needed to Harm (NNH) for any investigator defined adverse event =5, dizziness =10-15somnolence =10-14nausea =13-25fatigue =29-42.3  
    • US Food and Drug Administration (FDA) review (including unpublished data)5 reports NNH for any serious adverse event =250, syncope =500. 
    • Study limitations:  
      • Strict exclusion criteria (example no benzodiazepines, sleep aids, narcotics, antidepressants).1-4 
      • Change in primary outcome to find statistical significance.3,4  
      • Poor adverse events and drug interactions reporting.1,2  
  • FDA assessed phase 1-3 studies with 6,439 women reports safety concerns regarding hypotension, syncope, and somnolence, worsened with alcohol, oral contraceptives, and antifungals (among others).6 
  • Among 25 patients (23 male) given both alcohol (0.4g/kg) and flibanserin, 17% developed hypotension and/or syncope requiring intervention.6   
  • Following the second FDA rejection, an advocacy campaign entitled “Even the Score (sponsored in part by flibanserin manufacturersclaimed the FDA was exhibiting gender bias by rejecting flibanserin.7,8 
  • FDA approved flibanserin for Hypoactive Sexual Desire Disorder on its third application, with a risk mitigation strategy including alcohol contraindication and further research.6,8,9 
  • Flibanserin has not yet been approved for use in Canada. 

Latest Tools for Practice
Derniers outils pour la pratique

#370 Antibiotics or no antibiotics for acute diverticulitis, that is the question!

Do antibiotics change clinical outcomes for patients with acute uncomplicated diverticulitis?
Read Lire 0.25 credits available Crédits disponibles

#369 Remind me, do medications that target brain amyloid improve my dementia?

Are amyloid-targeting monoclonal antibodies safe and effective for mild cognitive impairment or Alzheimer’s dementia?
Read Lire 0.25 credits available Crédits disponibles

#368 Sodium Restriction in Heart Failure: Beneficial or pouring salt in the wound?

Does sodium restriction improve outcomes in patients with chronic heart failure?
Read Lire 0.25 credits available Crédits disponibles

This content is certified for MainPro+ Credits, log in to access

Ce contenu est certifié pour les crédits MainPro+, Ouvrir une session

  • Christina Korownyk MD CCFP
  • Robert Webster MD CCFP

1. Thorp J, Simon J, Dattani D, et al. J Sex Med. 2012 Mar; 9(3):793-804.

2. Derogatis LR, Komer L, Katz M, et al. J Sex Med. 2012 Apr; 9(4):1074-85.

3. Katz M, DeRogatis LR, Ackerman R, et al. J Sex Med. 2013 Jul; 10(7):1807-15.

4. Simon JA, Kingsberg SA, Shumel B, et al. Menopause. 2014 Jun; 21(6):633-40.

5. FDA Briefing Document. Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee. June 4, 2015. Available at: Last accessed January 19, 2016.

6. Centre for Drug Evaluation and Research. Risk Assessment and Risk Mitigation Review(s) Available at: Last accessed January 19, 2016.

7. Even the Score [website]. Last accessed January 19, 2016.

8. Moynihan R. BMJ. 2014 Oct 17; 349:g6246.

9. Joffe HV, Chang C, Sewell C, et al. N Engl J Med. 2016 Jan 14; 374(2):101-4.

Authors do not have any conflicts to disclose.