Dapoxetine (Priligy) in the US: FDA Status and US Alternatives
Is dapoxetine available in the US? No, Priligy is not FDA-approved. What that means, dapoxetine vs sertraline in a trial, and the US PE prescriptions with prices.
By Julian Caraulani · Last updated
SafetyReviewed by Dr. A. Goher, MBBS
- FDA-approved and compounded
- LegitScript seal ID shown
- 49 states (not AR)
Below: what dapoxetine is, why it never reached US shelves, how it compares with sertraline, and the US prescription routes with dated prices. We give no doses. A prescriber decides what fits you.
What is dapoxetine?
Dapoxetine is an SSRI, the same drug family as the antidepressants sertraline (Zoloft) and paroxetine (Paxil). SSRIs raise serotonin, a brain chemical. One known side effect of SSRIs is a delay in ejaculation. Dapoxetine was built to use that effect on purpose.
What sets it apart is timing. Dapoxetine is short-acting, so it was designed to be taken only before sex, rather than every day like the antidepressants. That is the reason men ask about it.
Is dapoxetine FDA-approved?
No. Its maker did apply. A drug review notes that "In December 2004, ALZA Corporation submitted a new drug application to the FDA for dapoxetine hydrochloride in the treatment of premature ejaculation" (Drugs in R&D profile, PubMed, read 14 November 2026). No approval followed, and no dapoxetine product is sold in US pharmacies.
The gap is wider than one drug. A 2010 review by US urologists said "there are currently no United States Food and Drug Administration-approved therapies for PE" (Tulane review, PubMed). That is still true today: no pill carries an FDA label for PE.
That is why the AUA guideline words its advice the way it does. It says "Clinicians should recommend daily SSRIs; on demand clomipramine or dapoxetine (where available); and topical penile anaesthetics as first-line pharmacotherapies in the treatment of premature ejaculation" (AUA guideline). In the US, dapoxetine is not one of the options that is available.
- FDA-approved and compounded
- LegitScript seal ID shown
- 49 states (not AR)
What about ordering Priligy from abroad?
Dapoxetine sold to US buyers comes from sellers outside the US system. This site does not list or link those sellers. A foreign website is outside the reach of US pharmacy boards, so no one checks what is in the pill.
The FDA warns that many online pharmacies sell drugs "often without requiring a prescription", and that they "often sell unapproved, counterfeit or otherwise unsafe medicines" (FDA: how to buy medicines safely online, read 14 November 2026). The US routes below come with a prescription, a licensed pharmacy and a known product.
Dapoxetine vs sertraline
Sertraline is the closest US option. It is FDA-approved for depression and anxiety, and clinicians prescribe it off-label for PE. Off-label means for a use the label does not cover. That is legal and common.
One trial compared them head to head. Doctors in Turkey split 120 men with lifelong PE into four groups for eight weeks. Two sertraline groups, one daily and one taken before sex at a higher strength, did best. The authors found that the two stronger sertraline groups "had better results in comparison with" the weaker before-sex sertraline group and with dapoxetine (Andrologia trial, PubMed, read 14 November 2026). The strengths were the trial's own and are not a dose for you.
That is one small study, so it is not the final word. It does show that sertraline, which you can get in the US, held its own against dapoxetine.
What the sertraline label warns about
Sertraline is a real antidepressant with real warnings. The Zoloft label carries a boxed warning: "Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients" (DailyMed: Zoloft label, read 14 November 2026). Its common side effects include nausea, loose stool, sweating, "ejaculation failure, and decreased libido". For PE, delayed ejaculation is the goal, but lower sex drive is not. Tell the prescriber about every other medicine you take, since SSRIs clash with several.
US prescription routes for PE, with prices
These are the PE products the programs we track publish, with read dates. Each comes with a clinician review.
| Program | PE product | Price | What it is | Read |
|---|---|---|---|---|
| Ro | Sertraline (generic Zoloft) | $24 a month | FDA-approved drug, used off-label | 7 Nov 2026 |
| Hims | Sex Rx + Climax Control | $39 a month | Compounded, not FDA-approved | 7 Nov 2026 |
| Strut Health | ParoxetineRx, paroxetine plus tadalafil | $49 for a 30-day supply | Compounded, not FDA-approved | 14 Nov 2026 |
| Rex MD | Sertraline for PE | Price not shown on its page | FDA-approved drug, used off-label | 7 Nov 2026 |
Compounded means a pharmacy mixes the product to order, and the FDA does not review it before sale. Strut Health lists ParoxetineRx at its starting price for a "30-day supply" (Strut Health).
Numbing creams, sprays and wipes are the other first-line choice in the AUA guideline. Several are sold over the counter. Our PE pills cost guide covers those, plus the stop-start and squeeze techniques, which cost nothing.
If weak erections are part of the problem, the guideline says to treat the ED too. Our guide on whether Viagra makes you last longer explains where ED pills fit.
How we rank programs
Payment never moves a rank. See PE programs ranked by score on our best PE programs page.
Questions
FAQ
Is dapoxetine available in the US?
No. Dapoxetine, sold as Priligy in other countries, is not FDA-approved, and no US pharmacy stocks it. Its maker applied to the FDA in 2004, but no approval followed. US clinicians prescribe other SSRIs off-label instead, such as sertraline, which costs from $24 a month through Ro.
Is dapoxetine FDA-approved?
No. The FDA has not approved dapoxetine for any use. No pill is FDA-approved for premature ejaculation in the US at all. The AUA guideline names dapoxetine as a first-line option only where it is available, which does not include the US.
What is Priligy?
Priligy is the brand name of dapoxetine, a short-acting SSRI made to be taken before sex to delay ejaculation. It is approved in a number of other countries but not in the US. SSRIs are the antidepressant family that includes sertraline and paroxetine, which US clinicians use off-label for PE.
Dapoxetine vs sertraline: which works better?
One trial of 120 men found sertraline taken daily, or taken before sex at a higher strength, worked better than dapoxetine over eight weeks. That is a single small study. Sertraline is FDA-approved for other conditions and widely sold in the US, while dapoxetine is not approved here.
What is the US alternative to dapoxetine?
Sertraline and paroxetine, prescribed off-label, are the usual US alternatives. Numbing creams and sprays are another first-line option. Some programs sell compounded paroxetine with tadalafil, which is not FDA-approved. Prices start at $24 a month for the cheapest PE plan we track. Compare every PE price on our PE cost page.
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