Dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI) specifically developed and approved for the on-demand treatment of premature ejaculation (PE) in adult men. It represents the first oral pharmacotherapy designed for this condition, offering a targeted approach that differs from daily-dosed antidepressants historically used off-label. Its rapid absorption and elimination profile allow for dosing approximately 1–3 hours prior to anticipated sexual activity, providing a clinically significant increase in intravaginal ejaculatory latency time (IELT). This medication addresses a significant unmet need in sexual medicine, providing a evidence-based option for men seeking to improve control over ejaculation and enhance sexual satisfaction for both partners.

Features

• Pharmacological Class: Selective Serotonin Reuptake Inhibitor (SSRI)
• Mechanism of Action: Rapid inhibition of serotonin reuptake, increasing synaptic serotonin levels in the central nervous system, which is believed to delay the ejaculatory reflex.
• Onset of Action: Rapid absorption; peak plasma concentrations (Tmax) reached within 1–2 hours post-administration.
• Elimination Half-Life: Approximately 1.5–2 hours, allowing for short duration of effect and reduced risk of accumulation.
• Available Strengths: 30 mg and 60 mg film-coated tablets.
• Prescription Status: Available by prescription only, following a thorough medical and sexual history assessment.

Benefits

• Significantly increases the time to ejaculation, improving intravaginal ejaculatory latency time (IELT) by a factor of 2.5 to 3 compared to placebo.
• Enhances perceived control over ejaculation and reduces personal distress related to sexual performance.
• Improves sexual satisfaction for both the patient and their partner, as demonstrated in validated patient-reported outcome measures.
• Provides a flexible, on-demand dosing regimen that aligns with sexual activity, avoiding the need for continuous daily medication.
• Supported by robust clinical trial data involving thousands of patients, establishing its efficacy and safety profile for this indication.
• Offers a specialized treatment option within the broader context of sexual health, moving beyond off-label use of conventional antidepressants.

Common use

Dapoxetine is indicated for the treatment of premature ejaculation (PE) in adult men aged 18–64 years. Premature ejaculation is defined clinically by a persistent or recurrent pattern of ejaculation occurring within approximately one minute of vaginal penetration (lifelong PE) or a clinically significant and bothersome reduction in latency time, often to three minutes or less (acquired PE), accompanied by an inability to delay ejaculation on all or nearly all vaginal penetrations, and negative personal consequences such as distress, bother, frustration, and/or avoidance of sexual intimacy. It is intended for use in men who meet these diagnostic criteria and who seek medical intervention to improve ejaculatory control. It is not indicated for use in women, adolescents, or men without a formal diagnosis of PE.

Dosage and direction

The recommended starting dose is 30 mg, taken orally as a single tablet approximately 1 to 3 hours prior to anticipated sexual activity. It may be taken with or without food; however, a high-fat meal may delay absorption. Based on efficacy and tolerability, the dose may be increased to 60 mg. The maximum recommended dosing frequency is once every 24 hours. The tablet should be swallowed whole with a full glass of water; it should not be divided, crushed, or chewed. It is imperative that treatment is initiated under the supervision of a physician experienced in managing sexual dysfunction, and the need for continued therapy should be reassessed at least every 6 months.

Precautions

Prior to initiation, a thorough medical and psychiatric history should be obtained to rule out other causes of ejaculatory dysfunction and to assess suitability. Use with caution in patients with a history of mood disorders. Patients should be monitored for the emergence of serotonin syndrome, neuroleptic malignant syndrome (NMS)-like events, orthostatic hypotension, syncope, and changes in mood or behavior. It is not recommended for use in men with significant hepatic impairment, and dose adjustment is advised in those with renal impairment (creatinine clearance <30 mL/min). Caution is advised in patients with underlying cardiovascular disease, and it should not be used in men for whom sexual activity is inadvisable. Patients should be advised that dizziness and syncope may occur.

Contraindications

Dapoxetine is contraindicated in patients with hypersensitivity to dapoxetine or any excipient in the formulation. It must not be used concomitantly with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOI therapy. Concomitant use with thioridazine is contraindicated. It is also contraindicated in patients with a history of mania or severe depression, and in those with significant ischemic heart disease, heart failure, conduction abnormalities, or stroke. Concomitant use with other serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tramadol, lithium, tryptophan) is contraindicated due to the increased risk of serotonin syndrome.

Possible side effect

The most commonly reported adverse reactions are dose-related and often related to its pharmacologic class. These include:

• Nausea (20.1% with 60 mg)
• Dizziness (11.6% with 60 mg)
• Headache (9.1% with 60 mg)
• Diarrhea (5.9%)
• Insomnia (5.5%)
• Fatigue (4.1%)
• Orthostatic hypotension (2.6%) Less common but serious side effects can include syncope (fainting), serotonin syndrome (characterized by agitation, hallucinations, tachycardia, hyperthermia, and neuromuscular abnormalities), and priapism. Patients should be instructed to discontinue use and seek immediate medical attention if they experience symptoms suggestive of a serious adverse event.

Drug interaction

Dapoxetine is primarily metabolized by multiple CYP enzymes (including CYP3A4, CYP2D6, and others) and is a weak CYP2D6 inhibitor. Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) is contraindicated. Concomitant use with moderate CYP3A4 inhibitors or strong CYP2D6 inhibitors should be undertaken with caution and may require a maximum dose of 30 mg. Potentiation of effects (e.g., increased risk of orthostatic hypotension, syncope, serotonin syndrome) is expected with other serotonergic drugs, alpha-adrenergic blockers, and moderate/strong CYP inhibitors. Concurrent use with alcohol is not recommended due to increased risk of adverse neurocognitive and cardiovascular effects.

Missed dose

As dapoxetine is taken on an as-needed basis prior to sexual activity, the concept of a “missed dose” does not apply in the traditional sense. If a dose is not taken within the recommended time frame prior to intercourse, it should be omitted. The patient should not take a double dose to make up for the missed opportunity. The next dose may be taken at the next anticipated sexual activity, adhering to the once-every-24-hours dosing limit.

Overdose

In cases of overdose, which may involve excessive serotonergic activity, symptoms could include serotonin syndrome (agitation, confusion, diaphoresis, tachycardia, hyperthermia, rigidity, myoclonus), dizziness, nausea, vomiting, and syncope. There is no specific antidote for dapoxetine overdose. Treatment consists of providing supportive care and managing symptoms, including ensuring a patent airway and adequate hydration. Gastric lavage or administration of activated charcoal may be considered if presented early. Close monitoring of vital signs and cardiac function is essential. Management of serotonin syndrome may require cyproheptadine and supportive measures.

Storage

Store dapoxetine tablets at room temperature (15°–30°C or 59°–86°F). Keep the medication in its original blister package to protect from light and moisture. Keep out of reach of children and pets. Do not use beyond the expiration date printed on the packaging. Dispose of any unused medication safely, via a medicine take-back program if available, to prevent accidental ingestion or misuse.

Disclaimer

This information is intended 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 before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read herein. The efficacy and safety of dapoxetine have been established for its approved indication; use outside of this is not recommended.

Reviews

Clinical trials and post-marketing surveillance have demonstrated that dapoxetine provides a statistically significant and clinically meaningful improvement in IELT and patient-reported outcomes (control over ejaculation, sexual satisfaction) compared to placebo. In large-scale, randomized, double-blind, placebo-controlled studies, men taking dapoxetine 60 mg experienced a 2.5 to 3-fold geometric mean increase in IELT. Patient global impression of change (PGI-C) scores consistently favored dapoxetine, with a majority of patients and their partners reporting “better” or “much better” sexual experiences. The most common reasons for discontinuation in trials were adverse events, primarily nausea and dizziness, which were generally mild to moderate in severity. Long-term extension studies support the maintenance of efficacy over time. Real-world evidence continues to align with clinical trial data, confirming its role as a valuable tool in the management of premature ejaculation.