Dapoxetine “On-Demand” for Premature Ejaculation: What Guidelines Say, What’s New, and What Are the Real Risks?
Prevalence of sexual dysfunction in men with chronic prostatitis/chronic pelvic pain syndrome. Psycho-biological correlates of free-floating anxiety symptoms in male patients with sexual dysfunctions.
| 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 |
Social phobia and premature ejaculation: a case-control study.
Can I get dapoxetine (Priligy) on the NHS?
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 dapoxetin sildenafil 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. 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).
Response varies
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). 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. 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. Dapoxetine for premature ejaculation.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Priligy Generic Dapoxetine | 60mg | 20 + 4 Pills | 77.31€ 73.63€ | |
| Viagra Professional | 100mg | 60 + 2 Pills | 146.74€ 139.75€ | |
| Priligy Generic Dapoxetine | 60mg | 10 Pills | 47.63€ 45.36€ | |
| Viagra Soft Tabs | 100mg | 120 + 8 Pills | 232.21€ 221.15€ | |
| Priligy Generic Dapoxetine | 60mg | 180 + 10 Pills | 494.76€ 471.20€ | |
| Priligy Generic Dapoxetine | 60mg | 60 + 8 Pills | 183.06€ 174.34€ | |
| Levitra Soft Tabs | 20mg | 20 Pills | 74.68€ 71.12€ | |
| Levitra Generic | 10mg | 30 + 4 Pills | 62.39€ 59.42€ | |
| Kamagra Soft Tabs | 100 mg | 32 Pills | 120.11€ 114.39€ | |
| Priligy Generic Dapoxetine | 60mg | 30 + 6 Pills | 106.65€ 101.57€ | |
| Priligy Generic Dapoxetine | 60mg | 90 + 10 Pills | 265.64€ 252.99€ | |
| Priligy Generic Dapoxetine | 60mg | 120 + 10 Pills | 341.26€ 325.01€ | |
| Viagra Generic | 50mg | 10 Pills | 26.87€ 25.59€ |
Emerging treatments for premature ejaculation: focus on dapoxetine. de Carufel F, Trudel G. Effects of a new functional-sexological treatment for premature ejaculation. Rapid ejaculation: a review of conceptual, etiological, and treatment issues. Arch Sex Behav 1995;24:447-72. Clinical follow-up of couples treated for sexual dysfunction. Arch Sex Behav 1985;14:467-89. Berkovitch M, Keresteci AG, Koren G. Efficacy of prilocaine-lidocaine cream in the treatment of premature ejaculation. Henry R, Morales A, Wyllie MG. TEMPE: Topical Eutectic-Like Mixture for Premature Ejaculation. Expert opinion on drug delivery 2008;5:251-61.
- Dapoxetine can improve confidence and sexual satisfaction.
- It is contraindicated in men with severe heart or liver conditions.
- The optimal dose varies; typically, 30 mg or 60 mg based on tolerance.
- Do not take dapoxetine with other SSRIs or serotonin drugs without medical advice.
- The onset of action is usually within 1-3 hours after intake.
- Dapoxetine is rapidly absorbed and eliminated from the body.
Porst H. An overview of pharmacotherapy in premature ejaculation. J Sex Med 2011;8:335-41. Psycho-Biological correlates of rapid ejaculation in patients attending an andrologic unit for sexual dysfunctions. A prospective study comparing paroxetine alone versus paroxetine plus sildenafil in patients with premature ejaculation.
A Practical Decision Framework: When Is “On-Demand” the Right Strategy?
Washington, D.C.: American Psychiatric Publishing Inc, 2000. Disorders of orgasm and ejaculation 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. Premature ejaculation, a review of 1130 cases. An empirical operationalization of DSM-IV diagnostic criteria for premature ejaculation.
When Should You Be Cautious?
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. Mattos RM, Marmo Lucon A, Srougi M.
About dapoxetine
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. 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.
How Does Dapoxetine Work?
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. International Classification of Diseases and Related Health Problems. Diagnostic and Statistical Manual of Mental Disorders 4th Ed. Tadalafil and fluoxetine in premature ejaculation: prospective, randomized, double-blind, placebo-controlled study. Effects of vardenafil administration on intravaginal ejaculatory latency time in men with lifelong premature ejaculation. Efficacy of sildenafil citrate (Viagra) in men with premature ejaculation. J Sex Med 2005;2:368-75.
More info about Priligy
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. Efficacy of type-5 phosphodiesterase inhibitors in the drug treatment of premature ejaculation: a systematic review. Does current scientific and clinical evidence support the use of phosphodiesterase type 5 inhibitors for the treatment of premature ejaculation? Tramadol for the treatment of premature ejaculation. Efficacy and safety of tramadol for premature ejaculation: a systematic review and meta-analysis. Wong BL, Malde S. The use of tramadol “on-demand” for premature ejaculation: a systematic review. Role of tramadol in premature ejaculation: a systematic review and meta-analysis. Safety and efficacy of tramadol hydrochloride on treatment of premature ejaculation. Selective serotonin reuptake inhibitors and tricyclic antidepressants in the acute treatment of chronic depression and dysthymia: A systematic review and meta-analysis. J Affect Disord 2013;144:7-15. Serotonin, serotonergic receptors, selective serotonin reuptake inhibitors and sexual behaviour. International society for sexual medicine’s guidelines for the diagnosis and treatment of premature ejaculation. Waldinger MD, Zwinderman AH, Olivier B. On-Demand treatment of premature ejaculation with clomipramine and paroxetine: a randomized, Double-Blind Fixed-Dose study with stopwatch assessment. A double-blind crossover trial of clomipramine for rapid ejaculation in 15 couples.
Side Effects of Dapoxetine
Physiology of ejaculation: emphasis on serotonergic control. Standard operating procedures in the disorders of orgasm and ejaculation. Ginton A. Copulation in noncopulators: effect of PCPA in male rats. Pharmacol Biochem Behav 1976;4:357-9.
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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. Serotonin and premature ejaculation: from physiology to patient management. An assessment of clomipramine (Anafranil) in the treatment of premature ejaculation. The efficacy of fluoxetine in the treatment of premature ejaculation: a Double-Blind placebo controlled study. Paroxetine treatment of premature ejaculation: a double-blind, randomized, placebo-controlled study.
Dapoxetine (Priligy): What It Is
Premature ejaculation associated with citalopram withdrawal. 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. Treatment of premature ejaculation with sertraline hydrochloride: a single-blind placebo controlled crossover study. The efficacy of citalopram in the treatment of premature ejaculation: a placebo-controlled study.
What are the side effects of dapoxetine (Priligy)?
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. A randomized double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of two doses of the tramadol orally disintegrating tablet for the treatment of premature ejaculation within less than 2 minutes.
- 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.
Topical anaesthetic use for treating premature ejaculation: a double-blind, randomized, placebo-controlled study. Incidence of sexual dysfunction associated with antidepressant agents: a prospective multicenter study of 1022 outpatients. Spanish Working Group for the Study of Psychotropic-Related Sexual Dysfunction.
- 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.
J Clin Psychiatry 2001;62 Suppl 3:10-21.
| Country | Approval Status | Notes |
|---|---|---|
| USA | Approved by FDA for PE | Prescription required |
| European Union | Approved in several countries | Prescription essential |
| Australia | Approved for PE | Sold under brand names |
| India | Available OTC in some pharmacies | Consult healthcare provider before use |
| Canada | Approved with prescription | Used for PE treatment |
SSRI-induced sexual dysfunction: fluoxetine, paroxetine, sertraline, and fluvoxamine in a prospective, multicenter, and descriptive clinical study of 344 patients. McCarty E, Dinsmore W. Dapoxetine: an evidence-based review of its effectiveness in treatment of premature ejaculation.
- 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.
Single- and multiple-dose pharmacokinetics of dapoxetine hydrochloride, a novel agent for the treatment of premature ejaculation. Pharmacokinetics of dapoxetine, a new treatment for premature ejaculation: Impact of age and effects of a high-fat meal.