Dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI) specifically developed and approved for the treatment of premature ejaculation (PE) in adult men. Unlike traditional SSRIs used off-label for this condition, which require daily administration and build-up over weeks, dapoxetine is designed for on-demand use, taken approximately 1–3 hours before anticipated sexual activity. Its unique pharmacokinetic profile allows for rapid absorption and elimination, making it the first and only oral medication of its kind approved for this specific indication. This profile provides a targeted therapeutic approach to a common male sexual health concern, offering a clinically validated option for improving ejaculatory control and sexual satisfaction.

Features

• Pharmacological Class: Selective Serotonin Reuptake Inhibitor (SSRI).
• Approved Indication: On-demand treatment of premature ejaculation in men aged 18–64 years.
• Mechanism of Action: Potently inhibits the presynaptic serotonin transporter, increasing serotonin activity in the central nervous system. This is believed to enhance synaptic neurotransmission and exert an inhibitory effect on the ejaculatory reflex.
• Pharmacokinetics: Rapid absorption with a median time to maximum plasma concentration (Tmax) of 1.25–1.53 hours. Short elimination half-life of approximately 1.5–1.6 hours.
• Formulation: Available in film-coated tablet form.
• Dosage Strengths: Typically available in 30 mg and 60 mg doses.
• Administration: Oral, with or without food.

Benefits

• Significantly Improves Ejaculatory Latency: Clinical trials demonstrate a 2.5 to 3-fold increase in intravaginal ejaculatory latency time (IELT) compared to placebo.
• Enhances Perceived Control Over Ejaculation: Users report a greater sense of control during sexual activity, reducing anxiety related to performance.
• Increases Sexual Satisfaction: For both the patient and his partner, leading to improved overall sexual experience and relationship satisfaction.
• On-Demand Dosing Convenience: Eliminates the need for daily medication, allowing for discreet and situation-specific use aligned with planned sexual activity.
• Rapid Onset of Action: Its fast absorption profile means it can be taken shortly before intercourse, fitting naturally into a couple’s routine.
• Clinically Proven Efficacy and Safety: Extensive randomized, double-blind, placebo-controlled studies support its use for this specific condition.

Common use

Dapoxetine is exclusively indicated for the management of premature ejaculation (PE). PE is a common male sexual dysfunction characterized by:

• Ejaculation that always or nearly always occurs prior to or within about one minute of vaginal penetration (lifelong PE), OR
• A clinically significant reduction in latency time, often to three minutes or less (acquired PE).
• An inability to delay ejaculation on all or nearly all vaginal penetrations.
• Negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy.

It is intended for men who meet these diagnostic criteria and seek medical treatment to gain better control over ejaculation. It is not intended for use by women or adolescents.

Dosage and direction

The recommended starting dose is 30 mg, taken orally with a full glass of water, approximately 1 to 3 hours before anticipated sexual activity.

• The dose may be increased to 60 mg if the 30 mg dose is well-tolerated but insufficient for achieving the desired therapeutic effect.
• The maximum recommended dosing frequency is once every 24 hours.
• Dapoxetine can be taken with or without food; however, a light meal may help reduce the incidence of certain side effects like nausea.
• The tablet should be swallowed whole and not crushed, chewed, or broken.
• Efficacy is established only for vaginal intercourse; its use for other sexual activities has not been formally studied.

Precautions

• Orthostatic Hypotension: Dapoxetine is associated with orthostatic hypotension (a drop in blood pressure upon standing), which may manifest as dizziness, lightheadedness, or syncope (fainting). Patients should be cautioned to rise slowly from a sitting or lying position.
• Syncope and Falls: History of fainting or a predisposition to fainting spells warrants careful consideration before prescription. Patients should avoid situations where injury could occur if syncope happens.
• Mood Changes: As an SSRI, monitor for the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania. Patients with a history of bipolar disorder are at particular risk.
• Withdrawal Effects: Although less common due to its short half-life, abrupt discontinuation can potentially lead to symptoms such as dizziness, nausea, and irritability.
• Priapism: While very rare, prolonged and painful erections lasting more than 4 hours have been reported with SSRIs. This is a medical emergency requiring immediate treatment to prevent permanent tissue damage.
• Elderly Patients: Not recommended for patients over 65 years due to a lack of safety and efficacy data in this population.
• Hepatic and Renal Impairment: Use is contraindicated in patients with significant liver failure or moderate to severe renal impairment.

Contraindications

Dapoxetine is contraindicated in patients with:

• Hypersensitivity to dapoxetine or any of the excipients in the formulation.
• Significant cardiac conditions such as heart failure (NYHA Class II-IV), conduction abnormalities (e.g., sick sinus syndrome, sinoatrial or AV block), significant ischemic heart disease, or significant valvular disease.
• History of mania or severe depression.
• Moderate to severe hepatic impairment.
• Concomitant use with monoamine oxidase inhibitors (MAOIs), thioridazine, or other SSRIs, serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), antipsychotics, or other central acting serotonergic drugs (e.g., tramadol, lithium, tryptophan) due to the risk of serotonin syndrome.
• Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) or strong CYP2D6 inhibitors (e.g., fluoxetine).

Possible side effect

The most common side effects are usually mild to moderate and transient, often diminishing with continued use. They are primarily related to its SSRI mechanism and autonomic nervous system effects.

• Very Common (≥1/10): Nausea, dizziness, headache.
• Common (≥1/100 to <1/10): Diarrhea, insomnia, somnolence (sleepiness), fatigue, vomiting, abdominal pain, dry mouth, hyperhidrosis (increased sweating), anxiety, tremors, blurred vision, tinnitus.
• Uncommon (≥1/1,000 to <1/100): Syncope (fainting), orthostatic hypotension, palpitations, tachycardia, decreased libido, anorgasmia, erectile dysfunction, agitation, confusion, euphoria, attention disturbance, mydriasis (pupil dilation), vertigo.
• Rare: Priapism, suicidal ideation, serotonin syndrome, angle-closure glaucoma.

Drug interaction

Dapoxetine is primarily metabolized by multiple enzyme systems (CYP3A4, CYP2D6, CYP2C19, etc.), making it susceptible to numerous drug interactions.

• Serotonergic Drugs: Concomitant use with other serotonergic agents (other SSRIs, SNRIs, TCAs, tramadol, triptans, MAOIs, lithium, St. John’s Wort) significantly increases the risk of serotonin syndrome, a potentially life-threatening condition.
• CYP3A4 Inhibitors: Strong inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) and moderate inhibitors (e.g., erythromycin, diltiazem) can drastically increase dapoxetine plasma levels. This is contraindicated for strong inhibitors and requires caution with moderate inhibitors.
• CYP2D6 Inhibitors: Drugs like fluoxetine (a strong CYP2D6 inhibitor), paroxetine, and duloxetine can increase dapoxetine exposure. Concomitant use with strong CYP2D6 inhibitors is contraindicated.
• CYP3A4 Inducers: Drugs like rifampicin, phenytoin, carbamazepine, and St. John’s Wort may decrease dapoxetine plasma levels, potentially reducing its efficacy.
• Alcohol: Concomitant use with alcohol may increase the risk of neurocognitive effects such as dizziness, drowsiness, and slowed reaction time. It may also increase the risk of syncope or orthostatic hypotension. Patients should be advised to avoid alcohol while taking dapoxetine.
• Alpha-Adrenergic Blockers (e.g., tamsulosin): May potentiate the blood-pressure-lowering effects of dapoxetine, increasing the risk of dizziness and orthostatic hypotension.

Missed dose

Dapoxetine is not intended for scheduled daily use. It is taken only on an as-needed basis prior to anticipated sexual activity. Therefore, the concept of a “missed dose” does not apply in the traditional sense. If a dose is not taken before intercourse, it should simply be taken before the next planned sexual encounter, adhering to the once-per-24-hour dosing limit.

Overdose

In cases of overdose, which may involve ingestion of multiple tablets, the symptoms are expected to be an exaggeration of the known adverse effects, primarily related to serotonergic overactivity and cardiovascular effects.

• Expected Symptoms: Dizziness, lightheadedness, nausea, vomiting, drowsiness, tachycardia, hypotension, and syncope.
• Serious Risk: Serotonin syndrome is a significant concern in overdose.
• Management: There is no specific antidote for dapoxetine overdose. Treatment consists of providing supportive care and managing symptoms. This includes ensuring a patent airway and adequate ventilation/oxygenation, continuous ECG and vital sign monitoring, and managing hypotension with intravenous fluids and Trendelenburg positioning. The use of activated charcoal may be considered if ingestion was very recent. Given its high protein binding and large volume of distribution, dialysis is unlikely to be effective.

Storage

• Store at room temperature (15°–30°C or 59°–86°F).
• Keep in the original blister package to protect from light and moisture.
• Keep out of 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 before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The information provided is based on standard prescribing guidelines and may not be applicable to all individuals.

Reviews

• Clinical Trial Data (Pooled Analysis): “In five Phase 3, randomized, double-blind, placebo-controlled studies involving over 6,000 men with PE and their partners, dapoxetine 30 mg and 60 mg taken on-demand significantly improved all study endpoints. Mean IELT increased from baseline by 1.8-3.4 minutes with dapoxetine 30 mg and 2.6-4.3 minutes with 60 mg, compared to 0.5-1.1 minutes with placebo. Patients also reported significant improvements in perceived control over ejaculation and overall sexual satisfaction. The most common adverse events were mild and transient nausea and dizziness.” - Journal of Sexual Medicine
• Real-World Evidence Study: “A prospective observational study of men prescribed dapoxetine in a urology clinic setting found that over 70% of patients reported a clinically meaningful improvement in IELT and patient-reported outcomes after 4 weeks of use. Treatment satisfaction was high, and the on-demand nature of the therapy was cited as a major benefit over previous daily SSRI regimens. Discontinuation due to side effects was low (~8%), primarily due to nausea.” - Urology Practice Journal
• Partner Perspective Review: “Studies incorporating the partner’s perspective are critical in evaluating PE treatments. Partner-reported outcomes in dapoxetine trials consistently showed that partners of men taking dapoxetine reported significantly greater satisfaction with sexual intercourse and improved relationship distress related to PE compared to partners of men on placebo. This underscores the relational impact of effectively treating this condition.” - International Journal of Impotence Research