FAQs: Dapoxetine (Priligy) and premature ejaculation
Premature ejaculation, a review of 1130 cases. An empirical operationalization of DSM-IV diagnostic criteria for premature ejaculation.
Getting the most from your treatment
Dapoxetine has demonstrated clinical efficacy and safety in five large, randomized, placebo-controlled phase III clinical trials. The postmarketing observational studies confirm its reliable safety profile and low prevalence of adverse events associated with its use. Dapoxetine is currently the oral drug of choice for on demand therapy of PE. Conflicts of Interest: Ege Can Serefoglu is consultant for Allergan Inc. Irvwine, CA, USA.
Efficacy and safety of dapoxetine/sildenafil combination tablets in the treatment of men with premature ejaculation and concomitant erectile dysfunction—DAP-SPEED Study
International Classification of Diseases and Related Health Problems. Diagnostic and Statistical Manual of Mental Disorders 4th Ed. Washington, D.C.: American Psychiatric Publishing Inc, 2000. Disorders of orgasm and ejaculation vardenafil with dapoxetine tablets in men. An evidence-based definition of lifelong premature ejaculation: report of the International Society for Sexual Medicine (ISSM) ad hoc committee for the definition of premature ejaculation. Int J Psychiatry Clin Pract 1988;2:287-93. Changing paradigms from a historical DSM-III and DSM-IV view toward an evidence-based definition of premature ejaculation. J Sex Med 2006;3:682-92. Recent advances in the classification, neurobiology and treatment of premature ejaculation. Giuliano F, Clément P. Physiology of ejaculation: emphasis on serotonergic control. Standard operating procedures in the disorders of orgasm and ejaculation. Ginton A.
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Copulation in noncopulators: effect of PCPA in male rats. Pharmacol Biochem Behav 1976;4:357-9. Hillegaart V, Ahlenius S. Facilitation and inhibition of male rat ejaculatory behaviour by the respective 5-HT1A and 5-HT1B receptor agonists 8-OH-DPAT and anpirtoline, as evidenced by use of the corresponding new and selective receptor antagonists NAD-299 and NAS-181. 5-HT1A and 5-HT1C/1D receptor agonists produce reciprocal effects on male sexual behavior of rhesus monkeys. Giuliano F, Clement P.
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Dapoxetine has no inhibitory or inductive effects on cytochrome P450 enzymes (38). Dapoxetine-N-oxide does not have any clinical efficacy, while desmethyldapoxetine and didesmethyldapoxetine have similar efficacy to dapoxetine, but as they comprise far smaller percentages of circulating dapoxetine species (less than 3%) their clinical effects are limited (80). At 24 hours, plasma dapoxetine concentrations drop to 3.5% and 3.9% of peak concentrations for 30 and 60 mg doses, respectively (80). The pharmacokinetics of dapoxetine are unaffected by multiple dosing with minimal apparent accumulation (80). In contrast, chronic use of paroxetine and sertraline has a 8- and 2-fold increases in plasma concentrations, respectively (85,86).
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At 24 hours following the last dose on day 9, there is 5.5% and 6.6% of peak plasma dapoxetine concentrations left in the blood circulation for the 30 and 60 mg doses, respectively (80). Moreover, co-administration of PDE-5 inhibitors with dapoxetine has no effect on the pharmacokinetics of dapoxetine (81). This favorable pharmacokinetic profile makes dapoxetine the drug of choice for on-demand treatment of PE. The long acting SSRIs, clomipramine, serotonin, fluoxetine and sertraline, inhibit increases in seminal vesicle pressure and the contractile responses induced by hypogastric nerve stimulation in the animal model of PE (87). However, dapoxetine appears to inhibit the ejaculatory reflex at a supraspinal level. Serotonin and premature ejaculation: from physiology to patient management. Premature ejaculation and serotonergic antidepressants-induced delayed ejaculation: the involvement of the serotonergic system. Behav Brain Res 1998;92:111-8. J Sex Med 2011;8:316-27. Study of the efficacy of fluoxetine and clomipramine in the treatment of premature ejaculation after opioid detoxification. Adson DE, Kotlyar M.
- Dapoxetine's impact on libido is generally minimal, focusing on ejaculation control.
- Use of dapoxetine should be part of an overall sexual health plan.
- Adherence to prescribed doses maximizes benefits and minimizes risks.
- Side effects usually resolve within a few hours or days.
- Avoid driving or operating heavy machinery after taking dapoxetine if drowsiness occurs.
- Regular discussions with your healthcare provider improve treatment outcomes.
Premature ejaculation associated with citalopram withdrawal.
- Economic burden of PE includes impact on quality of life.
- Dapoxetine can be cost-effective compared to no treatment or therapy alone.
- Adherence improved by clear instructions on timing of intake.
- Missed opportunity: if taken too late, may not be effective.
- Food does not significantly affect absorption; can be taken with/without.
- Potential for mild withdrawal-like symptoms if used very frequently.
- No established benefit for other sexual dysfunctions.
- Research continues on new formulations or delivery methods.
The role of short frenulum and the effects of frenulectomy on premature ejaculation. Ontogenetic profile of the expression of thyroid hormone receptors in rat and human corpora cavernosa of the penis. Chronic thyroxine treatment activates the 5-HT2A serotonin receptor in the mouse brain. J Sex Med 2011;8:90-6. The relationship between premature ejaculation and hyperthyroidism. El-Nashaar A, Shamloul R. Antibiotic treatment can delay ejaculation in patients with premature ejaculation and chronic bacterial prostatitis. J Sex Med 2007;4:491-6. Prevalence of chronic prostatitis in men with premature ejaculation. Prevalence of sexual dysfunction in men with chronic prostatitis/chronic pelvic pain syndrome.
| 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 |
Psycho-biological correlates of free-floating anxiety symptoms in male patients with sexual dysfunctions. Social phobia and premature ejaculation: a case-control study.
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35.1%) (96). Although these events were usually mild to moderate in severity, they still resulted in discontinuation from treatment, especially among patients who were treated with dapoxetine 60 mg (1.0%, 3.5%, 8.8%, and 10.0% of subjects with placebo, dapoxetine 30 mg prn, dapoxetine 60 mg prn, and dapoxetine 60 mg qd, respectively) (96). The adverse events included nausea (17.3%), dizziness (9.4%), headache (7.9%), diarrhoea (5.9%), somnolence (3.9%), fatigue (3.9%), insomnia (3.8%) and nasopharyngitis (3.1%). A recent dapoxetine postmarketing observational study confirmed its safety profile and low prevalence of adverse events, which were noted to be more common in patients aged >65 yr (21.4%) (104). No drug-drug interactions associated with dapoxetine have been reported (105).
How does Priligy work?
In men with PE and comorbid ED, who were on a stable regimen of a PDE5 inhibitor, dapoxetine provided meaningful treatment benefit and was generally well tolerated (106). There are a number of treatment options available for men who suffer from PE. These include psychological/behavioral therapy, topical anesthetic agents, PDE-5 inhibitors and tramadol hydrochloride. Off-label oral SSRIs are commonly prescribed for PE treatment; however, despite their efficacy, daily use of SSRIs comes with unwanted adverse events. Dapoxetine is a short-acting SSRI, designed specifically for the treatment of PE. Dysregulation of emotions and premature ejaculation (PE): alexithymia in 100 outpatients. J Sex Med 2007;4:1462-7. A new combination treatment for premature ejaculation: a sex therapist’s perspective. Feige AM, Pinsky MR, Hellstrom W.
About this article
Because of its rapid action and short half-life, the on-demand use of dapoxetine makes it a popular alternative for treating PE (94-97). Currently, dapoxetine is approved for the treatment of PE in over 50 countries. Several randomized controlled trials (RCTs) demonstrated the efficacy and safety of dapoxetine on more than 6,000 men with PE in over 25 countries (95,97-99) (Table 3). Integrated analysis of these phase III trials of dapoxetine demonstrate a significant increase in geometric mean IELT, from baseline (0.8 min) with 30 mg (2.0 min) and 60 mg (2.3 min) vs. placebo (1.3 min) at 12 weeks (96).
Redefining a sexual medicine paradigm: subclinical premature ejaculation as a new taxonomic entity
In addition to IELT, both doses of dapoxetine improved patient reported outcome measures compared to placebo (96). Dapoxetine was comparably effective both in men with lifelong and acquired PE (96,101,102). Despite these favorable outcomes, the results of the integrated analysis of the clinical dapoxetine trials revealed that 30.4% of the subjects included into the study discontinued, mostly due to lack of efficacy and personal reasons (96). These findings were in accordance with those of a recent report that demonstrated 20% of lifelong PE patients decided not to start dapoxetine treatment and almost 90% of the ones who initiated this therapy discontinued within one year because the beneficial effect were below expectations (24.4%), cost (22.1%), side effects (19.8%), loss of interest in sex 19.8%, and lack of efficacy 13.9% (103). Adverse events related to dapoxetine therapy were more common than placebo (56.1% vs. Dapoxetine for premature ejaculation. Emerging treatments for premature ejaculation: focus on dapoxetine. de Carufel F, Trudel G. Effects of a new functional-sexological treatment for premature ejaculation.
- 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.
Rapid ejaculation: a review of conceptual, etiological, and treatment issues.
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studied the effect of dapoxetine on pudendal motoneuron reflex discharges (PMRD) elicited by bilateral electrical stimulation of the dorsal nerve of the penis in the rat model (88). The results revealed that dapoxetine significantly increased PMRD latency and was more efficient than paroxetine in inhibiting PMRD (88). Microstimulation of the medullary reticular formation decreases the amplitude and increases the latency of PMRD (90). Intrathecal and intravenous injection of dapoxetine in rats with LPGi lesions did not alter either PMRD latency or amplitude, whereas rats with intact LPGi experienced significant increases in latency and decreases in amplitude of PMRD. Hence, dapoxetine was shown to inhibit the ejaculatory expulsion reflex by modulating activity at a supraspinal level and it is now established that LPGi is a requisite brain structure for this effect (91).
Statistical analysis
Clément’s behavioral study using Fos protein expression in the male rat as a marker of neuronal activity led to the identification of brain areas specifically involved in ejaculation (92). In rapidly ejaculating rats, the density of Fos expressing cells in the hypothalamus, amygdala, and LPGi were significantly higher than in the normal and sluggish categories (92,93). These results demonstrate that acute oral dapoxetine significantly prolongs latency and decreases the number of ejaculations in the rapid ejaculation rat model of PE when compared to controls (vehicle) (92). Fos expression levels in the hypothalamus, thalamus and amygdala were significantly lower in dapoxetine-treated rapid rats compared to vehicle-treated rapid rats (92). The rat model of PE clearly shows that dapoxetine significantly delays ejaculation by reducing neuronal activity in the excitatory thalamic and hypothalamic areas of the ejaculatory circuit.