Efficacy and safety of dapoxetine in treatment of premature ejaculation: an evidence-based review

Int J Clin Pract. 2016 Sep;70(9):723-33. doi: 10.1111/ijcp.12843. Epub 2016 Jul 25.

Abstract

Background: Premature ejaculation (PE) is a major issue in male sexual health, with a global prevalence estimated to be between 20% and 40%, making it the most common sexual dysfunction in men. PE causes distress and reduced quality of life for patients and has a negative impact on interpersonal relationships. Historically, it has been treated with cognitive therapy, behavioural methods and off-label use of selective serotonin reuptake inhibitors (SSRIs) usually used to treat depression and other psychological disorders. Dapoxetine is the only SSRI specifically designed to treat PE.

Mechanism of action: Dapoxetine hydrochloride is a potent inhibitor of serotonin reuptake transporters. Dapoxetine is suited for 'on-demand' treatment of PE because of its rapid absorption and short initial half-life.

Efficacy: Evidence from published studies showed that dapoxetine 30 mg or 60 mg taken 'on-demand' results in a significant increase in intravaginal ejaculatory latency time (IELT) when compared with placebo. Most patient-reported outcomes are clearly improved relative to placebo following dapoxetine therapy, indicating greater control over ejaculation, more satisfaction with intercourse, less ejaculation-related distress and significantly reduced interpersonal difficulties.

Safety: The most common adverse events with dapoxetine are nausea, dizziness, somnolence, headache, diarrhoea and insomnia. Usually they do not lead to drug discontinuation.

Conclusion: Dapoxetine is the only effective and safe available on-label oral treatment for PE, and its use can result in better quality of life for the patient and their sexual partner.

Publication types

  • Review

MeSH terms

  • Adolescent
  • Adult
  • Benzylamines / pharmacokinetics
  • Benzylamines / pharmacology
  • Benzylamines / therapeutic use*
  • Humans
  • Male
  • Meta-Analysis as Topic
  • Middle Aged
  • Naphthalenes / pharmacokinetics
  • Naphthalenes / pharmacology
  • Naphthalenes / therapeutic use*
  • Premature Ejaculation / drug therapy*
  • Randomized Controlled Trials as Topic
  • Selective Serotonin Reuptake Inhibitors / pharmacokinetics
  • Selective Serotonin Reuptake Inhibitors / pharmacology
  • Selective Serotonin Reuptake Inhibitors / therapeutic use*
  • Treatment Outcome
  • Young Adult

Substances

  • Benzylamines
  • Naphthalenes
  • Serotonin Uptake Inhibitors
  • dapoxetine