Premature ejaculation (PE) is a common male sexual health issue characterized by ejaculation that occurs with minimal sexual stimulation, before, during, or shortly after penetration, and before the person wishes it. This condition can cause distress and affect quality of life. Dapoxetine is the first oral medication developed specifically for the on-demand treatment of PE.
The Mechanism of Dapoxetine
Dapoxetine is classified as a short-acting selective serotonin reuptake inhibitor (SSRI). Unlike SSRIs used for depression that require time to build up in the body, dapoxetine is absorbed and eliminated rapidly. This property makes it suitable for on-demand use before sexual activity. Its primary function is to inhibit the serotonin transporter, increasing the action of serotonin at the postsynaptic cleft.
Serotonin is a neurotransmitter that acts as an inhibitory signal for the ejaculatory reflex. By increasing serotonin levels, dapoxetine enhances this inhibitory effect, helping to delay the signals that trigger ejaculation.
This potentiation of serotonin activity is mediated at a supraspinal level by modulating neuron activity in the brainstem. This modulation ultimately gives an individual more control over the timing of ejaculation.
Proper Administration and Dosage
Dapoxetine is intended for on-demand use, taken approximately one to three hours before anticipated sexual activity. This timing allows the medication to reach its maximum concentration in the bloodstream. It should be swallowed whole with a full glass of water and can be taken with or without food; sufficient water may reduce the risk of dizziness.
The recommended starting dose for most men is 30 mg. This initial dose allows a physician to assess the individual’s response and tolerance to the medication. The medication should not be taken more than once every 24 hours.
If the 30 mg dose proves insufficient and the individual has not experienced significant adverse reactions, a doctor may increase the dosage. The maximum recommended dose is 60 mg. A careful evaluation of the benefits and risks should be conducted by a physician before escalating the dose.
Clinical Efficacy and Outcomes
The effectiveness of dapoxetine has been confirmed in several randomized, placebo-controlled clinical trials. A primary measure in these studies is the Intravaginal Ejaculatory Latency Time (IELT), the time from penetration to ejaculation. Men taking dapoxetine showed a statistically significant increase in their IELT compared to those taking a placebo.
On average, men with a baseline IELT of about 0.9 minutes experienced an increase to approximately 3.1 to 3.6 minutes with 30 mg and 60 mg doses, respectively. This compares to an increase to 1.9 minutes with a placebo. This equates to a roughly two- to three-fold increase in IELT for those taking the medication.
Beyond the objective measure of IELT, studies also assessed patient-reported outcomes. Men treated with dapoxetine reported improvements in perceived control over ejaculation, personal distress, and satisfaction with sexual intercourse compared to the placebo group. It is important for users to understand that dapoxetine is a treatment, not a cure, and individual results can vary.
Side Effects and Health Considerations
Before starting treatment, a physician should conduct a thorough medical examination, including a history of dizziness upon standing (orthostatic events). The most commonly reported side effects are often dose-dependent, meaning they are more likely to occur and be more severe at the 60 mg dose. They include:
- Nausea
- Dizziness
- Headache
- Diarrhea
- Insomnia
- Fatigue
In rare instances, more serious effects may occur, such as fainting (syncope) or changes in mood. To reduce the risk of dizziness and fainting, patients should stay well-hydrated. Combining dapoxetine with alcohol can increase the likelihood of such side effects and should be avoided.
Dapoxetine is not suitable for everyone. It should not be used by men with significant heart conditions or moderate to severe liver impairment. It is also contraindicated for individuals taking certain medications, including monoamine oxidase inhibitors (MAOIs), thioridazine, and other SSRIs. A 14-day waiting period is required after stopping these medications.
Patients must provide their doctor with a complete medical history and a list of all medications they are taking. Men with a history of bipolar disorder, mania, or bleeding disorders should use dapoxetine with caution. The medication is approved only for adult men between 18 and 64 who have been diagnosed with premature ejaculation.