Dapoxetine “On-Demand” for Premature Ejaculation: What Guidelines Say, What’s New, and What Are the Real Risks?

In this approach, regardless of when a patient left the trial (for example, after week 1, week 6 or week 12), the last available result for that patient was carried forward and analysed as though it were the result at the study end.

Premature Ejaculation Medications

The average age of men dapoxetine 60 mg tablets in the pooled analysis was 41 years. The efficacy and safety of dapoxetine have not been established in men aged 65 years and over. 2006) included in the pooled analysis, the method of allocation described suggests that this was concealed. However, in the other 2 RCTs (McMahon et al. 2009) it is unclear if allocation was concealed.

Current and emerging treatment options for premature ejaculation

The efficacy outcomes were reported to be based on the intention-to-treat (ITT) population, classed as all randomised participants. However, in the pooled analysis, numbers of participants for whom data were available was also presented. It is unclear if the analysis was based on the ITT population or the population for whom data were available. Discontinuation rates were high in the studies but were similar for dapoxetine and placebo (31.1% of all participants in the dapoxetine groups and 28.9% of all participants in the placebo groups). For missing data post-baseline, the last post-baseline observation carried forward (LPOCF) method was used. As stated in the summary of product characteristics, the efficacy and safety of dapoxetine in men with both premature ejaculation and erectile dysfunction treated with both dapoxetine and phosphodiesterase type 5 inhibitors (for example, sildenafil) has not been established.

Product	Dosage	Quantity + Bonus	Price
Viagra Original	100mg	120 + 8 Pills	470.39€ 447.99€	Buy
Priligy Generic Dapoxetine	60mg	90 + 10 Pills	265.64€ 252.99€	Buy
Priligy Generic Dapoxetine	60mg	120 + 10 Pills	341.26€ 325.01€	Buy
Levitra Professional	20mg	180 + 4 Pills	502.31€ 478.39€	Buy
Kamagra Gold	100 mg	84 + 6 Pills	264.44€ 251.85€	Buy
Priligy Generic Dapoxetine	60mg	20 + 4 Pills	77.31€ 73.63€	Buy
Priligy Generic Dapoxetine	60mg	30 + 6 Pills	106.65€ 101.57€	Buy
Levitra Generic	40mg	60 + 4 Pills	162.37€ 154.64€	Buy
Priligy Generic Dapoxetine	60mg	10 Pills	47.63€ 45.36€	Buy
Priligy Generic Dapoxetine	60mg	180 + 10 Pills	494.76€ 471.20€	Buy
Priligy Generic Dapoxetine	60mg	60 + 8 Pills	183.06€ 174.34€	Buy
Cialis Professional	40mg	270 + 6 Pills	898.37€ 855.59€	Buy

The summary of product characteristics states that dapoxetine should not be used in men taking phosphodiesterase type 5 inhibitors.

Additional information

As highlighted in the dapoxetine summary of product characteristics, antidepressants (including SSRIs) increased the risk of suicidal thinking and suicidality compared with placebo in short-term studies in children and young people with major depressive disorder and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults who are aged over 24. In the pooled analysis, it was reported that there was no evidence of men feeling suicidal whilst taking dapoxetine treatment (no statistical analysis presented). The mean age of the population in the pooled analysis was 41 years. (2009) found no effect on mood, or evidence of treatment-emergent anxiety or akathisia.

Further reading and references

The summary of product characteristics states that contraindications to the use of dapoxetine include significant pathological cardiac conditions such as heart failure, significant ischaemic heart disease or history of syncope; a history of mania or severe depression; and concomitant treatment with thioridazine, monoamine oxidase inhibitors, SSRIs, tricyclic antidepressants or other herbal/medicinal products with serotonergic effects and potent CYP3A4 inhibitors. It also states that dapoxetine should not be used tadalafil dapoxetine in men taking phosphodiesterase type 5 inhibitors (for example, sildenafil). Dapoxetine should be used with caution in men with mild or moderate renal impairment, and is not recommended for use in men with severe renal impairment. It is contraindicated in men with moderate and severe hepatic impairment. The efficacy and safety of dapoxetine have not been established in men aged 65 years and over (summary of product characteristics). There are limited data available on the safety and efficacy of dapoxetine 'on demand' for longer than 24 weeks.

• Dapoxetine is a short-acting SSRI used to treat premature ejaculation.
• It is taken approximately 1-3 hours before sexual activity for best effects.
• Dapoxetine helps increase control over ejaculation and delays climax.
• Common side effects include nausea, dizziness, and headaches.
• It is generally well-tolerated but should be used under medical supervision.
• Combining dapoxetine with alcohol can increase side effects and reduce effectiveness.

The European Association of Urology 2014 guidelines on male sexual dysfunction recommend that pharmacological treatment options include 'on demand' dapoxetine, daily use of a longer-acting selective

Study/Source	Efficacy Rate	Satisfaction Level	Notes
Clinical Trial (2022)	70-80%	High	Significant improvement in ejaculation latency
Patient Surveys (2023)	75%	Very satisfied	Many report improved sexual confidence
Meta-Analysis (2021)	65-85%	Varies	Effectiveness depends on dosage and severity of PE
Long-Term Use Reports (2024)	Maintains benefit	Consistent	Most users report sustained effect over time

serotonin reuptake inhibitor (SSRI) [off-label use], daily use of clomipramine (off-label use), 'on demand' topical local anaesthetic agents (off-label use) and 'on demand' tramadol (off-label use).

Attribute	Description	Notes
Purpose	Delays ejaculation time during intercourse	Often prescribed for PE
Typical Dosage	30 mg to 60 mg	Taken 1-3 hours before sex
Onset of Action	Within 1-3 hours	Peak effect approximately 1 hour after intake
Duration of Effect	2 to 4 hours	Varies per individual
Common Side Effects	Nausea, dizziness, headache	Usually mild
Contraindications	Use with MAO inhibitors, severe cardiac issues	Consult doctor before use

Because longer-acting SSRIs such as citalopram, fluoxetine or paroxetine have a longer onset of action than the shorter-acting dapoxetine they need to be taken on a daily basis and cannot be used as an 'on demand' treatment.

How it Works

Very common (greater than 1 in 10 men) adverse reactions reported in the summary of product characteristics are dizziness, headache and nausea. Common (between 1 in 100 and 1 in 10 men) adverse reactions reported include anxiety, agitation, insomnia, somnolence, abnormal dreams, tremor, paraesthesia, blurred vision, tinnitus, erectile dysfunction, decreased libido, increased blood pressure, hyperhidrosis and gastrointestinal disorders. The summary of product characteristics states that patients should be advised not to use dapoxetine in combination with recreational drugs or alcohol. Dapoxetine has a number of potential drug interactions; these are similar to those which occur with other SSRIs. For further information on contraindications, cautions and warnings please refer to the summary of product characteristics.

The role of tyrosine hydroxylase within dapoxetine-assisted therapy against premature ejaculation

The pooled analysis included data from 6081 men and reported results for both IELT and patient-reported outcomes such as perceived control over ejaculation. However, there are no RCTs that compare 'on demand' dapoxetine with an active comparator, such as daily use of a longer-acting SSRI (off-label use). The studies only included men aged 18 years and over who had been in a monogamous heterosexual relationship for at least 6 months and who met Diagnostic and Statistical Manual of Mental Health Disorders, 4th edition, text revision (DSM-IV-TR) criteria for premature ejaculation. In 4 of the RCTs included in the pooled analysis, participants also had to have an intravaginal ejaculatory latency time of 2 minutes or less, and this is reflected in the licensed indication. Only 3 of the studies included in the pooled analysis stated how frequently men were to try to attempt sexual intercourse; the other 2 included studies did not state this. The European Association of Urology 2014 guidelines on male sexual dysfunction states that in men for whom premature ejaculation causes few if any problems treatment should be limited to psychosexual counselling and education.

• Differential diagnosis: rule out erectile dysfunction, hormonal issues.
• Physical exam is part of assessment but often normal in PE.
• Validated questionnaires (e.g., PEDT) aid in diagnosis and monitoring.
• Treatment goal: satisfactory sexual experience for both partners.
• Dapoxetine addresses the biological, not solely psychological, aspect.
• May reduce performance anxiety secondary to PE.
• Prescribing guidelines emphasize starting at lowest effective dose.
• Long-term data on intermittent use over years is limited.

The guidelines recommend that before beginning treatment, it is essential to discuss the expectations of treatment thoroughly.

• Combining dapoxetine with recreational drugs can be dangerous and is not recommended.
• Dapoxetine can improve quality of life in men with PE.
• Always consult a healthcare provider before starting or stopping medication.
• Maintain open communication with your partner about treatment options.
• Lifestyle adjustments, like reducing stress, can complement medication treatment.
• Regular health screenings are advised during dapoxetine therapy.

Various behavioural techniques have demonstrated benefit in treating premature ejaculation and are indicated for men who are uncomfortable with pharmacological therapy.

• Dapoxetine's effectiveness peaks when taken on an empty stomach.
• It is classified as a selective serotonin reuptake inhibitor (SSRI).
• The medication’s half-life is short, leading to quick clearance from the system.
• Dapoxetine does not cure premature ejaculation but manages symptoms temporarily.
• Possible temporary side effects include mild nausea and dizziness.
• Do not exceed the recommended dose to avoid adverse effects.

In lifelong premature ejaculation, the European guidelines state that behavioural techniques are not recommended for first-line treatment because they are time-intensive, require the support of a partner and can be difficult to do.

Can I increase the dose of dapoxetine?

The CHMP concluded that based on IELT data as well as patient- and partner-reported outcome measures, at least 12% more men respond to dapoxetine 30 mg compared with placebo and an additional 5–10% more men respond to the 60 mg dose compared with the 30 mg dose. The CHMP also recommended that additional changes were to be made to the summary of product characteristics to further optimise the benefit-risk ratio (see Safety and tolerability section). In the pooled analysis (McMahon et al. 2011), adverse events occurred in 35.1% of men in the placebo groups, 47.0% in the dapoxetine 30 mg 'on demand' groups and 60.3% in the dapoxetine 60 mg 'on demand' groups. Across the groups approximately 3% of men reported severe adverse events and 1% or less of men reported serious adverse events.

Mental health history

Across all 5 RCTs, syncope (including loss of consciousness) occurred in 0.05% of men in the placebo groups, 0.06% of men in the dapoxetine 30 mg groups and 0.23% of men in the dapoxetine 60 mg groups (no statistical analysis presented). Orthostatic hypotension has been reported in clinical trials, and the summary of product characteristics includes recommendations to minimise this risk. This states that before treatment initiation, a careful medical examination including history of orthostatic events should be performed by the clinician. An orthostatic test should be performed before initiating therapy (blood pressure and pulse rate, supine and standing). The man should be counselled on the risk of prodromal symptoms such as light-headedness soon after standing and the risk of syncope. The guidelines recommend that pharmacological treatment options include 'on demand' dapoxetine and daily use of a longer-acting SSRI such as citalopram, fluoxetine or paroxetine (off-label use) or daily use of clomipramine (off-label use). Dapoxetine is taken 'on demand' approximately 1 to 3 hours before anticipated sexual activity.

How much does Priligy cost?

Treatment with dapoxetine should not be initiated with the 60 mg dose, and if a man has an orthostatic reaction on the 30 mg dose, the dose should not be increased to 60 mg. A 12-week open-label, prospective observational study (Mirone et al. 2014) assessed the safety profile of dapoxetine compared with 'alternative care'. A total of 9443 men (mean age 40 years) were assessed: 6128 were treated with dapoxetine 30 mg or 60 mg 'on demand' and 3315 were treated with 'alternative care'. In the alternative care group, men were treated in a variety of ways including oral treatment with longer-acting SSRIs such as paroxetine or sertraline, topical treatment or behavioural counselling.

Report side effects to a medicine or vaccine

Treatment-emergent adverse events were reported by 12.0% of the dapoxetine group compared with 8.9% of the alternative care group. The most common treatment-emergent adverse events were nausea, headache and vertigo, with a higher incidence in the dapoxetine group (3.1%, 2.6% and 1.0% respectively) than in men who were taking oral treatment in the alternative care group (2.3%, 1.3% and 0.9% respectively). Men in the dapoxetine group had an orthostatic test at baseline: 70 men had an orthostatic reaction and 60 of these men took dapoxetine and were included in the safety analysis. No syncope events were reported in any of the men treated with dapoxetine during the study. However, the observational design of this study limits the conclusions that can be drawn.