What is dapoxetine?

Dapoxetine is a drug developed specifically for the treatment of premature ejaculation (PE) in men. It belongs to the class of selective serotonin reuptake inhibitors (SSRIs), commonly used as antidepressants, but differs from other SSRIs in its rapid onset of action and short half-life, characteristics that make it ideal for use as needed.

Initially studied as an antidepressant, dapoxetine was subsequently repositioned for the treatment of PE thanks to its unique pharmacokinetic profile, which allows for rapid action and quick elimination from the body. This distinguishes it from traditional SSRIs, which are unsuitable for PE due to their long duration of action and delayed effect.

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Uses of dapoxetine

Premature ejaculation is one of the most common male sexual dysfunctions, affecting approximately 20–30% of men worldwide. It is characterized by a reduced ability to control ejaculation, which occurs earlier than desired, often within one minute of vaginal penetration. This condition can have a significant negative impact on psychological well-being, relationships, and quality of life.

Dapoxetine is the first oral treatment specifically approved for PE, demonstrating a clinically significant increase in intravaginal ejaculatory latency time (IELT) and improved ejaculatory control.

Clinical studies have shown that, compared to placebo, dapoxetine 30 mg and 60 mg increases IELT by up to 2.7–3.4 times and 3.4–4.3 times, respectively, in subjects with baseline IELT of less than one minute (McMahon et al., 2010).

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Dapoxetine and premature ejaculation in athletes who use steroids

The use of anabolic steroids is relatively widespread among athletes and can cause hormonal imbalances responsible for various sexual dysfunctions, including premature ejaculation. Steroid-induced androgenic alterations can interfere with the neuroendocrine mechanisms that regulate ejaculation.

Dapoxetine has also been shown to be effective in PE associated with steroid use, thanks to its ability to modulate central serotonergic pathways and increase levels of serotonin, a key neurotransmitter in delaying the ejaculatory reflex. Several studies indicate a significant improvement in ejaculatory control and quality of sexual life in athletes suffering from steroid-induced PE (Corona et al., 2011).

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Combination of dapoxetine with tadalafil or sildenafil

Dapoxetine can be used in combination with erectile dysfunction drugs such as tadalafil or sildenafil. This combination acts on both the duration of sexual intercourse and the quality of the erection, offering a more comprehensive therapeutic approach to male sexual health and improving overall satisfaction with intercourse.

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Mechanism of action of dapoxetine

The mechanism of action of dapoxetine is based on the inhibition of the serotonin transporter, resulting in an increase in serotonin concentration in the synaptic space. This enhancement of serotonergic activity in the central nervous system modulates the neural circuits involved in ejaculation, delaying the ejaculatory reflex.

Serotonin plays a fundamental role in regulating mood, emotions, and sexual functions; its increase contributes directly to better control of ejaculation (Kirkeby et al., 2010).

After oral administration, dapoxetine is rapidly absorbed, reaching peak plasma levels within 1–2 hours. Its short half-life (approximately 1.5 hours) allows for rapid elimination, reducing the risk of accumulation and side effects typical of SSRIs in chronic use (Buvat et al., 2009).

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Therapeutic indications for dapoxetine

Treatment of premature ejaculation

Dapoxetine is indicated for men aged 18 to 64 years who suffer from premature ejaculation. Randomized, placebo-controlled clinical trials have shown that dapoxetine:

• significantly increases the IELT

• improves perceived control over ejaculation

• reduces the psychological distress associated with PE

• increases individual and couple sexual satisfaction

The drug is taken 1–3 hours before sexual intercourse, according to an "on-demand" approach that allows for spontaneity and flexibility in your sex life.

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Other potential uses

Although dapoxetine is an SSRI, it is not indicated as an antidepressant for the long-term treatment of depression due to its short half-life. However, in off-label contexts, it may offer transient benefits for symptoms of acute anxiety. Such uses are not sufficiently documented, however, and require further clinical studies (Rowland, 2011).

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Dapoxetine dosage

Recommended dosages

• Initial dose: 30 mg

• Dose increase: up to 60 mg if necessary and well tolerated

• Maximum frequency: once every 24 hours

Individualization of dosage is essential to optimize efficacy and minimize side effects. Periodic clinical monitoring is recommended (Sangkum et al., 2013).

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Side effects of dapoxetine

The most common side effects include:

• nausea

• dizziness

• headache

• diarrhea

• insomnia

In some cases, syncope (fainting) may occur, especially within the first three hours after taking the medication and more frequently with the 60 mg dose. For this reason, it is recommended to avoid driving and activities that require full attention after taking the medication (Buvat et al., 2009).

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Precautions and contraindications

Dapoxetine is contraindicated in patients with:

• serious cardiovascular diseases

• cardiac conduction disorders

• concomitant use of MAOIs

• history of mania or severe depression

Alcohol consumption may increase the risk of adverse effects, particularly syncope. Combination with potent CYP3A4 inhibitors, which may increase plasma concentrations of dapoxetine, is also not recommended (McMahon, 2012).

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Storage of dapoxetine

Dapoxetine should be stored at room temperature (15–30°C) in its original packaging, protected from light and moisture. It should be kept out of the reach of children and pets to ensure the safety and effectiveness of the drug (FDA, 2020).

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