A 12-week open-label, prospective observational study (Mirone et al.
What do we need to know?
It also states that dapoxetine should not be used 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 tadalafil with dapoxetine tablets 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). Very common (greater than 1 in 10 men) adverse reactions reported in the summary of product characteristics are dizziness, headache and nausea.
Why dapoxetine is used for PE
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 pooled analysis included data from 6081 men and reported results for both IELT and patient-reported outcomes such as perceived control over ejaculation.
Derivative Synchronous Fluorescence Spectroscopy for the Simultaneous Determination of Dapoxetine Hydrochloride and Vardenafil in Binary Mixtures
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 average age of men in the pooled analysis was 41 years. 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'.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Priligy Generic Dapoxetine | 60mg | 180 + 10 Pills | 494.76€ 471.20€ | |
| Priligy Generic Dapoxetine | 60mg | 120 + 10 Pills | 341.26€ 325.01€ | |
| Priligy Generic Dapoxetine | 60mg | 60 + 8 Pills | 183.06€ 174.34€ | |
| Levitra Generic | 40mg | 120 + 8 Pills | 302.37€ 287.97€ | |
| Levitra Generic | 20mg | 30 + 4 Pills | 70.59€ 67.23€ | |
| Viagra Generic | 50mg | 10 Pills | 26.87€ 25.59€ | |
| Priligy Generic Dapoxetine | 60mg | 30 + 6 Pills | 106.65€ 101.57€ | |
| Kamagra 100 mg | 100 mg | 180 + 6 Pills | 436.79€ 415.99€ | |
| Cialis Original | 20mg | 4 Pills | 41.99€ 39.99€ | |
| Priligy Generic Dapoxetine | 60mg | 20 + 4 Pills | 77.31€ 73.63€ | |
| Viagra Generic | 50mg | 30 + 4 Pills | 54.26€ 51.68€ | |
| Priligy Generic Dapoxetine | 60mg | 90 + 10 Pills | 265.64€ 252.99€ | |
| Cialis Generic | 20mg | 360 + 10 Pills | 427.34€ 406.99€ | |
| Priligy Generic Dapoxetine | 60mg | 10 Pills | 47.63€ 45.36€ |
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. Treatment-emergent adverse events were reported by 12.0% of the dapoxetine group compared with 8.9% of the alternative care group.
- Dapoxetine has been shown to significantly increase ejaculatory latency time.
- It is not intended to treat all aspects of sexual dysfunction.
- Use of dapoxetine may require dose adjustments based on side effects.
- The medication should be stored safely out of children's reach.
- Monitoring response and side effects enhances safe use of dapoxetine.
- Dapoxetine should be used only as part of a broader treatment plan.
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.
| Side Effect | Frequency | Severity | Management Tips |
|---|---|---|---|
| Nausea | Common | Mild to moderate | Take with food, follow dose instructions |
| Dizziness | Common | Mild | Avoid driving after taking |
| Insomnia | Occasional | Mild | Use earlier in the day if sleep disturbances occur |
| Sudden Drop in Blood Pressure | Rare | Moderate | Monitor BP if prone to hypertension |
| Serotonin Syndrome | Very Rare | Severe | Discontinue and seek medical attention if symptoms occur |
However, the observational design of this study limits the conclusions that can be drawn. 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).
Privacy and Confidentiality in Sexual Health Care
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. 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 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 tadalafil with dapoxetine tablets and severe hepatic impairment.
- Dapoxetine is sometimes used off-label to treat other sexual dysfunctions.
- It is not a cure but a symptom management medication.
- Men should discuss potential side effects thoroughly before starting treatment.
- The medication has been studied and approved in several countries for PE.
- In case of overdose, seek emergency medical help immediately.
- Dapoxetine use requires careful monitoring for long-term safety.
The efficacy and safety of dapoxetine have not been established in men aged 65 years and over (summary of product characteristics). 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 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 average age of men 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. 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.
How long does dapoxetine make you last in bed
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. Treatment-emergent adverse events were reported by 12.0% of the dapoxetine group compared with 8.9% of the alternative care group.
Patient-reported global impression of change (PGIC)
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. 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.
How Dapoxetine works
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. 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 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).
Additional information
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. The guidelines recommend that before beginning treatment, it is essential to discuss the expectations of treatment thoroughly. Various behavioural techniques have demonstrated benefit in treating premature ejaculation and are indicated for men who are uncomfortable with pharmacological therapy. 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. 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).
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Dapoxetine is taken 'on demand' approximately 1 to 3 hours before anticipated sexual activity. This may reduce the incidence of SSRI-related adverse effects compared with the off-label use of once-daily longer acting SSRIs, although there are no direct RCTs to provide evidence for this. However, some men may prefer to take a daily dose which may allow more spontaneity than a planned 'on demand' treatment. Dapoxetine is licensed for treating premature ejaculation in adult men aged 18 to 64 years. The summary of product characteristics states that dapoxetine should only be prescribed to men who meet all the following criteria: An intravaginal ejaculatory latency time of less than 2 minutes and An intravaginal ejaculatory latency time of less than 2 minutes and Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the man wishes and Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the man wishes and Marked personal distress or interpersonal difficulty as a consequence of premature ejaculation and Marked personal distress or interpersonal difficulty as a consequence of premature ejaculation and A history of premature ejaculation in the majority of intercourse attempts over the prior 6 months.
Important information about all medicines
Therefore, men will need to be appropriately assessed and given a diagnosis of premature ejaculation in line with the above criteria before dapoxetine can be considered. In addition, the summary of product characteristics states that a careful appraisal of the individual benefit/risk ratio should be carried out after the first 4 weeks of treatment (or at least after 6 doses of treatment) to determine whether continuing treatment is appropriate. If dapoxetine is continued, the benefit/risk balance should be re-evaluated at least every 6 months. For missing data post-baseline, the last post-baseline observation carried forward (LPOCF) method was used. 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.
When Dapoxetine May Be Prescribed
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. The summary of product characteristics states that dapoxetine should not be used in men taking phosphodiesterase type 5 inhibitors. There are limited data available on the safety and efficacy of dapoxetine 'on demand' for longer than 24 weeks. 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 serotonin reuptake inhibitor (SSRI) [off-label use], daily use of clomipramine (off-label use), 'on demand' topical local anaesthetic dapoxetine 60mg tablet price agents (off-label use) and 'on demand' tramadol (off-label 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. 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. The guidelines recommend that before beginning treatment, it is essential to discuss the expectations of treatment thoroughly.
- Taking dapoxetine with food may delay the onset of action.
- Do not share dapoxetine with others, even if they have similar symptoms.
- Dapoxetine can be used with lifestyle changes to improve sexual health.
- Patients should avoid heavy alcohol consumption during treatment.
- The medication may cause temporary flu-like symptoms in some users.
- Follow-up with your healthcare provider as recommended for ongoing assessment.
Various behavioural techniques have demonstrated benefit in treating premature ejaculation and are indicated for men who are uncomfortable with pharmacological therapy. 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. 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).
- Some men may experience mood changes or irritability with dapoxetine.
- Alcohol use can increase the risk of side effects when taking dapoxetine.
- Dapoxetine is not approved for use in women or children.
- Store dapoxetine in a cool, dry place away from children.
- Always report any unusual or severe side effects to your doctor.
- It is important to get a medical assessment before starting dapoxetine.
Dapoxetine is taken 'on demand' approximately 1 to 3 hours before anticipated sexual activity. This may reduce the incidence of SSRI-related adverse effects compared with the off-label use of once-daily longer acting SSRIs, although there are no direct RCTs to provide evidence for this. However, some men may prefer to take a daily dose which may allow more spontaneity than a planned 'on demand' treatment.
Surgical Intervention
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. The efficacy outcomes were reported to be based on the intention-to-treat (ITT) population, classed as all randomised participants.
Written and reviewed by our qualified team
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. 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.
Priligy side effects
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. The summary of product characteristics states that dapoxetine should not be used in men taking phosphodiesterase type 5 inhibitors. There are limited data available on the safety and efficacy of dapoxetine 'on demand' for longer than 24 weeks. 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 serotonin reuptake inhibitor (SSRI) [off-label use], daily use of clomipramine (off-label use), 'on demand' topical local anaesthetic dapoxetine 60mg tablet price agents (off-label use) and 'on demand' tramadol (off-label 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. Dapoxetine is licensed for treating premature ejaculation in adult men aged 18 to 64 years.
| 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 |
The summary of product characteristics states that dapoxetine should only be prescribed to men who meet all the following criteria: An intravaginal ejaculatory latency time of less than 2 minutes and An intravaginal ejaculatory latency time of less than 2 minutes and Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the man wishes and Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the man wishes and Marked personal distress or interpersonal difficulty as a consequence of premature ejaculation and Marked personal distress or interpersonal difficulty as a consequence of premature ejaculation and A history of premature ejaculation in the majority of intercourse attempts over the prior 6 months. Therefore, men will need to be appropriately assessed and given a diagnosis of premature ejaculation in line with the above criteria before dapoxetine can be considered.
| Aspect | Details |
|---|---|
| Drug Class | Selective Serotonin Reuptake Inhibitor (SSRI) |
| Mechanism of Action | Increases serotonin levels in the nervous system, delaying ejaculation |
| Half-Life | Approximately 19 hours |
| Metabolism | Liver (via CYP enzymes) |
| Excretion | Primarily in urine |
| Interaction Potential | May interact with other serotonergic drugs |
In addition, the summary of product characteristics states that a careful appraisal of the individual benefit/risk ratio should be carried out after the first 4 weeks of treatment (or at least after 6 doses of treatment) to determine whether continuing treatment is appropriate. If dapoxetine is continued, the benefit/risk balance should be re-evaluated at least every 6 months.