What is the recommended treatment and dosage for premature ejaculation using Dapoxetine (Priligy)?

Dapoxetine for Premature Ejaculation

Dapoxetine is the only SSRI specifically approved for on-demand treatment of premature ejaculation, dosed at 30 mg or 60 mg taken 1-3 hours before sexual activity, with the 60 mg dose providing superior efficacy (3.0-fold increase in IELT vs 2.5-fold with 30 mg). 1

Dosing Recommendations

Starting Dose and Titration

• Begin with dapoxetine 30 mg taken on-demand, 1-3 hours before anticipated sexual intercourse 1
• Increase to 60 mg if the 30 mg dose provides insufficient response and is well-tolerated 1
• The 60 mg dose demonstrates greater efficacy, particularly in men with baseline IELT <30 seconds (4.3-fold increase vs 3.4-fold with 30 mg) 1

Timing and Administration

• Take 1-3 hours before sexual activity for optimal plasma concentrations 2, 3
• This is an on-demand regimen, not daily dosing 1
• Dapoxetine is effective from the first dose, unlike traditional SSRIs that require daily administration 4

Efficacy Data

Objective Measures

• 30 mg dose increases IELT by 2.5-fold over baseline (from ~0.9 minutes to 2.0-2.7 minutes geometric mean) 1, 2, 3
• 60 mg dose increases IELT by 3.0-fold over baseline (from ~0.9 minutes to 2.3-3.1 minutes geometric mean) 1, 2, 3
• Both doses significantly outperform placebo (1.6-fold increase) across all studies 2

Patient-Reported Outcomes

• All Premature Ejaculation Profile (PEP) domains improve significantly: perceived control over ejaculation, satisfaction with sexual intercourse, personal distress, and interpersonal difficulty 2, 5
• Clinical Global Impression of Change shows significant improvement vs placebo (P<0.001) 2, 5

Safety Profile

Common Adverse Events (Dose-Dependent)

• Nausea: 8.7% (30 mg) and 20.1% (60 mg) vs placebo 4
• Dizziness: 3.0% (30 mg) and 6.2% (60 mg) 4
• Headache: 5.9% (30 mg) and 6.8% (60 mg) 4
• Diarrhea: 3.9% (30 mg) and 6.8% (60 mg) 4

Discontinuation Rates

• Treatment discontinuation due to adverse events: 1.7% (30 mg) and 5.1% (60 mg) vs 0.3% placebo 3
• Long-term discontinuation reaches 90% at 2 years, primarily due to cost (29.9%) and disappointment with on-demand nature (25%), not safety concerns 1

Important Safety Considerations

• No evidence of anxiety, akathisia, suicidality, mood changes, or discontinuation syndrome following abrupt withdrawal 2
• Can be safely combined with PDE5 inhibitors for concomitant erectile dysfunction 1

Clinical Decision Algorithm

First-Line Recommendation

Dapoxetine is recommended as a first-line approved on-demand treatment option for lifelong premature ejaculation 1

When to Choose Dapoxetine Over Other SSRIs

• Patient prefers on-demand dosing rather than daily medication 1
• Infrequent sexual activity where daily SSRI exposure is undesirable 1
• Desire for regulatory-approved medication specifically for PE (available in most countries except USA) 1

When to Consider Alternatives

• If cost is prohibitive: Consider off-label daily SSRIs (paroxetine 10-20 mg daily provides 8.8-fold IELT increase) 1, 6
• If systemic side effects are concerning: Consider topical lidocaine/prilocaine spray (6.3-fold IELT increase with minimal systemic effects) 1
• If partial response to dapoxetine: Consider combination with PDE5 inhibitors, which enhances confidence and sexual satisfaction 1

Critical Caveats

Geographic Availability

• Dapoxetine is NOT approved in the USA; off-label SSRIs remain the only option for American patients 1
• Widely available in Europe, Asia-Pacific, and other regions 1

Treatment Expectations

• PE typically returns upon discontinuing therapy; this is likely a chronic condition requiring ongoing treatment 1
• Patients should be counseled that this is symptomatic treatment, not curative 1

Concomitant Erectile Dysfunction

• If PE is secondary to ED, treat ED first or concomitantly before addressing PE 1
• Dapoxetine can be safely combined with PDE5 inhibitors 1