What are the indications and usage guidelines for dapoxetine (a selective serotonin reuptake inhibitor) in adult men, particularly those between 18 and 65 years old, with or without a history of depression, anxiety, or other medical conditions?

Dapoxetine Indications

Dapoxetine is indicated specifically for on-demand treatment of premature ejaculation (PE) in adult men aged 18-64 years with lifelong or acquired PE. 1

Primary Indication

Premature Ejaculation Treatment:

• Dapoxetine is the only selective serotonin reuptake inhibitor (SSRI) specifically approved for PE treatment in many countries (notably excluding the USA) 1
• Available in 30 mg and 60 mg doses for on-demand use, taken 1-3 hours before anticipated sexual activity 1
• Approved for both lifelong PE (present since first sexual experiences) and acquired PE (developed after period of normal function) 1

Patient Population Criteria

Age Requirements:

• Approved for adult men aged 18-64 years 1
• No specific approval for men over 65 years, though this reflects trial populations rather than contraindication 1

Diagnostic Requirements:

• Intravaginal ejaculatory latency time (IELT) assessment is essential for diagnosis 1
• Must have perceived lack of control over ejaculation 1
• Presence of distress and/or interpersonal difficulty due to ejaculatory dysfunction 1
• Physical examination should identify any anatomical abnormalities that may contribute to PE or coexisting erectile dysfunction 1

Clinical Context and Positioning

First-Line Treatment Option:

• Dapoxetine is recommended as a first-line pharmacological agent alongside daily SSRIs, on-demand clomipramine, and topical penile anesthetics 1
• The 2025 European Association of Urology guidelines specifically list dapoxetine as an approved on-demand treatment option for PE, distinguishing it from off-label SSRI use 1

Efficacy Profile:

• 30 mg dose increases IELT 2.5-fold; 60 mg dose increases IELT 3.0-fold 1
• In patients with baseline IELT <30 seconds, efficacy increases to 3.4-fold (30 mg) and 4.3-fold (60 mg) 1
• Improves patient-reported outcomes including control over ejaculation, satisfaction with intercourse, and reduced interpersonal difficulty 2, 3

Important Clinical Considerations

Combination Therapy:

• Can be safely combined with PDE5 inhibitors for men with concurrent erectile dysfunction 1
• If PE is secondary to erectile dysfunction, treat ED first or concomitantly 1

Common Pitfalls:

• Discontinuation rates reach 90% at 2 years, primarily due to cost (29.9%) and disappointment with on-demand nature (25%) 1
• Dose-dependent side effects include nausea, diarrhea, and dizziness 1
• Unlike daily SSRIs, dapoxetine's short half-life makes it unsuitable for continuous daily dosing but ideal for on-demand use 2, 3

Contraindications and Cautions:

• Should be avoided in men with history of bipolar depression due to risk of mania (general SSRI precaution) 1
• Risk of serotonin syndrome when combined with other serotonergic drugs 1
• Associated with vasovagal-mediated syncope in development studies 4

Not Indicated For

• Depression or other psychiatric conditions (dapoxetine is not approved as an antidepressant) 2, 3
• Continuous daily use (pharmacokinetics designed for on-demand dosing) 2, 5
• Patients under 18 years of age 1