From the Guidelines
Yes, there are approved drugs for treating premature ejaculation, with dapoxetine being the only medication specifically approved for this condition in many countries. The treatment of premature ejaculation typically involves the use of selective serotonin reuptake inhibitors (SSRIs) such as paroxetine, sertraline, and fluoxetine, which are often prescribed off-label for this condition 1. These medications work by increasing serotonin levels in the brain, which helps delay ejaculation by inhibiting the ejaculatory reflex. Some key points to consider when treating premature ejaculation with SSRIs include:
- Dapoxetine (Priligy) is a short-acting SSRI taken 1-3 hours before sexual activity at doses of 30-60mg, and is the only medication specifically approved for premature ejaculation in many countries, though not in the United States 1.
- Other SSRIs like paroxetine (20-40mg daily), sertraline (50-200mg daily), and fluoxetine (20-40mg daily) are commonly prescribed off-label and typically take 2-3 weeks to become effective 1.
- Topical anesthetics containing lidocaine or prilocaine can also be applied 10-20 minutes before sex to reduce penile sensitivity, with lidocaine/prilocaine cream (2.5 gm) applied for 20 to 30 minutes prior to intercourse having been shown to increase latency time 1.
- Side effects of SSRIs may include nausea, headache, and decreased libido, while topical treatments might cause temporary numbness or mild irritation 1.
- Treatment is typically ongoing as symptoms often return when medication is discontinued 1. Clinicians should recommend daily SSRIs, on-demand clomipramine or dapoxetine, and topical penile anesthetics as first-line agents of choice in the treatment of premature ejaculation 1.
From the FDA Drug Label
Male and Female Sexual Dysfunction with SSRIs Although changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that selective serotonin reuptake inhibitors (SSRIs) can cause such untoward sexual experiences Table 5 below displays the incidence of sexual side effects reported by at least 2% of patients taking sertraline in placebo-controlled trials Table 5 Adverse EventSertraline Hydrochloride TabletsPlacebo Ejaculation Failure1(Primarily Delayed Ejaculation) 14% 1% Decreased Libido26%1%
No, there are no drugs approved specifically for the treatment of premature ejaculation in the provided drug labels. However, SSRIs like sertraline can cause ejaculatory delay as a side effect, which may be beneficial for patients with premature ejaculation 2.
From the Research
Approved Drugs for Premature Ejaculation
- Dapoxetine is a potent selective serotonin reuptake inhibitor (SSRI) that has been approved for the treatment of premature ejaculation 3, 4, 5.
- An anesthetic spray containing lidocaine and prilocaine (Fortacin™) is also officially approved for the treatment of premature ejaculation 4.
Efficacy and Safety of Approved Drugs
- Dapoxetine has been shown to be effective and safe in treating lifelong premature ejaculation, with significant improvements in intravaginal ejaculatory latency time (IELT) and Premature Ejaculation Profile (PEP) items 3, 5.
- Fortacin has also demonstrated considerable efficacy and may be reliably used on-demand 4.
- The most common adverse events associated with dapoxetine include nausea, dizziness, and headache 3.
Comparison with Other Treatments
- Dapoxetine has been compared to other treatments, including topical anaesthetics, selective serotonin reuptake inhibitors (SSRIs), and phosphodiesterase type 5 inhibitors (PDE5Is), and has been found to be a effective and safe option for the treatment of premature ejaculation 6, 7, 5.
- A network meta-analysis of randomized clinical trials found that dapoxetine 30 mg has a high likelihood of being the "best" treatment option for premature ejaculation 5.