What is dapoxetine used to treat in men between 18 and 65 years old?

Dapoxetine: Primary Indication and Clinical Use

Dapoxetine is specifically approved for the on-demand treatment of premature ejaculation (PE) in men aged 18-64 years. 1

Mechanism and Formulation

• Dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI) designed specifically for as-needed use, distinguishing it from traditional daily SSRIs used off-label for PE 1
• Available in 30 mg and 60 mg doses, taken 1-3 hours before anticipated sexual activity 1, 2
• Its short-acting pharmacokinetic profile minimizes the risk of chronic side effects and withdrawal symptoms associated with daily SSRIs 3

Efficacy Data

Dapoxetine demonstrates substantial improvements in ejaculatory control:

• The 30 mg dose increases intravaginal ejaculatory latency time (IELT) by 2.5-fold over baseline 1, 2
• The 60 mg dose increases IELT by 3.0-fold over baseline 1, 2
• In men with severe PE (baseline IELT <30 seconds), efficacy is even greater: 3.4-fold increase with 30 mg and 4.3-fold increase with 60 mg 1, 2
• Clinical trials involving over 6,000 men demonstrated significant improvements in all patient-reported outcomes including perceived control over ejaculation, satisfaction with intercourse, and PE-related personal distress 4, 5

Regulatory Status

• Approved for PE treatment in many countries worldwide, notably excluding the United States 1
• Specifically indicated for men between 18-65 years of age with documented PE 1, 6

Safety Profile

Common dose-dependent side effects include: 1

• Nausea (most common, occurring in 8.7% with 30 mg and 20.1% with 60 mg)
• Diarrhea (3.9% with 30 mg, 6.8% with 60 mg)
• Dizziness (3.0% with 30 mg, 6.2% with 60 mg)
• Headache (5.9% with 30 mg, 6.8% with 60 mg)

Important safety considerations:

• No documented adverse effects on sperm parameters, fertility, or testicular function across clinical trials involving over 10,000 men 3
• No evidence of withdrawal syndrome, anxiety, akathisia, suicidality, or mood changes 4
• Can be safely combined with PDE5 inhibitors (e.g., sildenafil, tadalafil) for men with coexisting erectile dysfunction 1, 2

Clinical Context and Limitations

A critical pitfall to recognize: Treatment discontinuation rates reach 90% at 2 years, primarily due to cost (29.9%) and patient disappointment with the on-demand nature of treatment (25%) 1, 2

• If erectile dysfunction coexists with PE, treat the ED first or concomitantly, as some acquired PE may be secondary to ED 2
• Dapoxetine is recommended as first-line pharmacotherapy specifically for lifelong PE when on-demand treatment is preferred 1
• For men with frequent sexual activity, daily SSRI therapy (particularly paroxetine 10-20 mg daily) provides superior efficacy with an 8.8-fold increase in IELT compared to dapoxetine's 2.5-3.0-fold increase 2, 7