Dapoxetine – SSRI for Premature Ejaculation (Not FDA-Approved in U.S.)
Dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI) used primarily for the treatment of premature ejaculation (PE) in men. Although it is not approved by the U.S. Food and Drug Administration (FDA), it has been approved and marketed in many countries including India, several European countries, and parts of Asia and Latin America.
Approved Use of Dapoxetine
Dapoxetine is indicated for men aged 18 to 64 years with a clinical diagnosis of premature ejaculation, defined as ejaculation occurring within a minute of vaginal penetration or with minimal sexual stimulation.
How Dapoxetine Works
As a fast-acting SSRI, Dapoxetine increases serotonin levels in the nervous system, which delays the ejaculation reflex. It is typically taken 1 to 3 hours before sexual activity and is not meant for daily use.
Dosage & Administration
- Initial dose: 30 mg taken 1–3 hours before anticipated sexual activity
- If well tolerated but ineffective: Dose may be increased to 60 mg
- Not recommended for daily use
Common Side Effects
- Nausea
- Dizziness
- Headache
- Insomnia
- Fatigue
Serious side effects may include syncope (fainting), mood changes, or serotonin syndrome. Patients are advised not to consume alcohol while using Dapoxetine due to increased risk of side effects.
Availability and Legal Status
Though Dapoxetine is not FDA-approved in the U.S., it is available in countries such as:
- India
- Germany
- Italy
- Spain
- South Korea
- Mexico
Important Warnings
- Not suitable for individuals with significant heart issues
- Should not be used with other serotonergic drugs or MAOIs
- Not to be taken with alcohol or recreational drugs
Conclusion
Dapoxetine is an effective option for many men with premature ejaculation. However, due to its non-approval by the FDA, its use should be carefully evaluated and always supervised by a qualified healthcare provider.