Dapoxetine: Effective On-Demand Treatment for Premature Ejaculation

Dapoxetine
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Synonyms | |||
Dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSI) specifically developed and approved for the on-demand treatment of premature ejaculation (PE) in adult men. It represents a significant advancement in urological and sexual medicine, offering a pharmacologically targeted approach to a condition that affects a substantial portion of the male population. Unlike daily-dosed antidepressants sometimes used off-label, dapoxetine’s rapid absorption and elimination profile is uniquely suited for use prior to anticipated sexual activity. Its efficacy is well-documented in numerous randomized controlled trials, demonstrating a clinically significant increase in intravaginal ejaculatory latency time (IELT) and improvements in patient-reported outcome measures, including control over ejaculation and satisfaction with sexual intercourse.
Features
- Pharmacological Class: Selective Serotonin Reuptake Inhibitor (SSRI).
- Approved Indication: On-demand treatment of premature ejaculation (PE) in men aged 18-64 years.
- Mechanism of Action: Potent inhibition of the serotonin transporter, increasing serotonin activity in the synaptic cleft within the central nervous system, which is believed to exert a delaying effect on the ejaculatory reflex.
- Pharmacokinetic Profile: Rapid absorption (Tmax ~1-2 hours) and short elimination half-life (approximately 1.5-1.6 hours for the parent compound).
- Dosage Forms: Available in film-coated tablet formulations (30 mg and 60 mg strengths).
- Administration: Taken orally with a full glass of water, approximately 1-3 hours prior to anticipated sexual activity.
Benefits
- Significantly Prolongs Ejaculatory Latency: Clinical studies consistently demonstrate a 2.5 to 3-fold increase in mean intravaginal ejaculatory latency time (IELT) compared to placebo.
- Improves Perceived Control: Users report a greater sense of control over the timing of their ejaculation, reducing anxiety associated with sexual performance.
- Enhances Sexual Satisfaction: Leads to improvements in both personal sexual satisfaction and partner satisfaction, as measured by validated psychometric instruments like the PEP (Premature Ejaculation Profile).
- On-Demand Dosing Convenience: Eliminates the need for daily medication, allowing for flexible use only when needed and minimizing long-term drug exposure.
- Evidence-Based Efficacy: Supported by a robust body of clinical evidence from large-scale, multinational, double-blind, placebo-controlled trials.
Common use
Dapoxetine is indicated for the treatment of premature ejaculation (PE) in adult men aged 18 to 64 years. Premature ejaculation is defined by the International Society for Sexual Medicine (ISSM) as a persistent or recurrent pattern of ejaculation occurring within approximately one minute of vaginal penetration (lifelong PE) or a clinically significant reduction in latency time, often to three minutes or less (acquired PE), which is associated with the inability to delay ejaculation on all or nearly all vaginal penetrations, and which causes negative personal consequences such as distress, bother, frustration, and/or the avoidance of sexual intimacy. It is not intended for use by women, adolescents, or men without a diagnosis of PE. Dapoxetine should be used as part of a comprehensive treatment approach, which may include psychological counseling and behavioral techniques.
Dosage and direction
The recommended starting dose is 30 mg, taken orally approximately 1 to 3 hours before anticipated sexual activity. The dosing may be increased to the maximum recommended dose of 60 mg based on efficacy and tolerability. It is critical to adhere to the 24-hour dosing limit (one dose per 24 hours). The tablet should be swallowed whole with a full glass of water; it should not be divided, crushed, or chewed. Dapoxetine can be taken with or without food; however, a high-fat meal may moderately increase absorption time and drug exposure, which could potentially influence the side effect profile. The need for continued treatment should be reassessed periodically by a healthcare provider.
Precautions
- Orthostatic Hypotension: Dapoxetine is associated with syncope, dizziness, and orthostatic hypotension. Patients should be cautioned about activities requiring complete alertness, such as driving or operating machinery, especially during the initial treatment period or after a dose increase.
- Mood Changes: As with other SSRIs, although used intermittently, dapoxetine may be associated with mood alterations. Patients should be monitored for the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania. Patients with a history of mania/hypomania or bipolar disorder should be closely supervised.
- Fainting (Syncope): A history of fainting or conditions that predispose to fainting (e.g., low blood volume, dehydration, heart disease) warrants careful consideration before prescription.
- Moderate Renal Impairment: A maximum dose of 30 mg is recommended for patients with moderate renal impairment. It is not recommended for use in patients with severe renal impairment.
- Moderate Hepatic Impairment: Use is not recommended in patients with hepatic impairment.
- Epilepsy: Caution is advised in patients with a history of epilepsy or those with conditions that may lower the seizure threshold.
Contraindications
- Hypersensitivity to dapoxetine or any of the excipients in the formulation.
- Concomitant administration with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing treatment with an MAOI due to the risk of serotonin syndrome. Similarly, at least 7 days should elapse after stopping dapoxetine before starting an MAOI.
- Concomitant administration with thioridazine or within 14 days of discontinuing treatment with thioridazine.
- Concomitant administration with other central nervous system active substances (e.g., alcohol, psychotropic drugs, antipsychotics, antidepressants).
- Patients with a history of mania or severe depression.
- Significant pathological cardiac conditions such as heart failure (NYHA Class II-IV), conduction abnormalities (e.g., sick sinus syndrome, Wolff-Parkinson-White syndrome, significant bradycardia, 2nd or 3rd degree AV block), significant ischemic heart disease, or significant valvular disease.
- Severe hepatic impairment.
Possible side effect
The most commonly reported adverse reactions are dose-related and are typically mild to moderate in intensity, often diminishing with continued use. They are primarily related to its SSRI mechanism and autonomic nervous system effects.
- Very Common (β₯1/10): Dizziness, headache, nausea.
- Common (β₯1/100 to <1/10): Diarrhea, insomnia, somnolence (sleepiness), fatigue, anxiety, tremor, blurred vision, vomiting, abdominal pain, dry mouth, hyperhidrosis (increased sweating), flushing, increased blood pressure, tachycardia (increased heart rate), erectile dysfunction, decreased libido.
- Uncommon (β₯1/1,000 to <1/100): Syncope (fainting), attention disturbance, paresthesia (tingling sensation), tinnitus, palpitations, orthostatic hypotension, irritability, agitation, euphoric mood, confusion, bruxism (teeth grinding), dyspepsia, flatulence, rash, pruritus (itching), chills, vertigo, tension, pollakiuria (frequent urination).
- Rare (<1/1,000): Suicidal ideation and behavior.
Drug interaction
Dapoxetine is primarily metabolized by multiple CYP enzymes (including CYP3A4, CYP2D6, and others) and is a moderate CYP2D6 inhibitor. Concomitant use with other serotonergic drugs increases the risk of serotonin syndrome.
- Potent CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin): Concomitant use is contraindicated. These drugs significantly increase dapoxetine exposure.
- Moderate CYP3A4 Inhibitors (e.g., erythromycin, fluconazole, diltiazem): Concomitant use is not recommended.
- Potent CYP2D6 Inhibitors (e.g., fluoxetine, paroxetine): Concomitant use is not recommended.
- Serotonergic Drugs (e.g., SSRIs, SNRIs, tricyclic antidepressants, tramadol, triptans, tryptophan, St. John’s Wort): Increased risk of serotonin syndrome (symptoms include agitation, hallucinations, coma, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea). Concomitant use should be avoided.
- Alcohol: Concomitant use can increase the risk of adverse reactions such as dizziness, lightheadedness, and syncope. Patients should be advised to avoid alcohol while taking dapoxetine.
- Phenytoin: Concomitant use may increase phenytoin exposure; monitoring of phenytoin levels is recommended.
- Alpha1-adrenoreceptor antagonists (e.g., tamsulosin): May increase the risk of orthostatic hypotension and syncope.
Missed dose
Dapoxetine is not intended for daily scheduled use. It is taken on an as-needed basis. If a dose is missed, it should be taken only if there is sufficient time prior to sexual activity (1-3 hours). The missed dose should not be taken after sexual activity has begun. The 24-hour dosing limit (one tablet per 24 hours) must never be exceeded.
Overdose
In case of overdose, supportive measures should be instituted. Symptoms of overdose are expected to be an extension of the known adverse reaction profile, including serotonergic effects (e.g., serotonin syndrome: agitation, confusion, diaphoresis, hallucinations, hyperreflexia, myoclonus, shivering, tachycardia), dizziness, nausea, vomiting, and syncope. There is no specific antidote for dapoxetine overdose. Treatment should consist of general supportive measures, including monitoring of vital signs and ECG. Gastric lavage and administration of activated charcoal may be considered if presented early. Due to high protein binding and large volume of distribution, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be of benefit.
Storage
Store at room temperature (15Β°C to 30Β°C or 59Β°F to 86Β°F). Keep the medication in its original blister package to protect from light and moisture. Keep out of the reach of children and pets. Do not use after the expiration date printed on the packaging.
Disclaimer
This information is for educational and informational purposes only and does not constitute medical advice. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication. Never disregard professional medical advice or delay in seeking it because of something you have read here. The author and publisher are not responsible for any specific health or allergy needs that may require medical supervision and are not liable for any damages or negative consequences from any treatment, action, application, or preparation, to any person reading or following the information in this document.
Reviews
- Clinical Trial Data (Pooled Analysis): “In five randomized, double-blind, placebo-controlled studies involving over 6,000 men, dapoxetine 30 mg and 60 mg demonstrated a statistically significant and clinically relevant increase in IELT (from approximately 0.9 minutes at baseline to 3.1 and 3.6 minutes, respectively, versus 1.9 minutes for placebo). Patient-reported outcomes for control and satisfaction were also significantly improved compared to placebo.” - Journal of Sexual Medicine
- Urologist, Germany: “Dapoxetine provides a valuable, evidence-based tool in our arsenal for treating PE. Its on-demand nature is a key advantage for many patients who are averse to daily medication. Managing patient expectations regarding potential side effects, particularly dizziness and nausea during the initial doses, is crucial for adherence and overall satisfaction.”
- Patient, 42: “It took a couple of tries to get the timing right, but the difference in control has been remarkable. It has significantly reduced the performance anxiety that was making the problem worse. The initial lightheadedness was noticeable but faded.”













