Dapoxetine (Priligy): Why This PE Medication Hasn’t Been Approved in the US & What to Try Instead

Dapoxetine, also known as Priligy, is prescribed for the treatment of premature ejaculation (PE). Despite several promising clinical trials, the drug remains unavailable in the United States. 

Here, we’ll discuss everything you should know about dapoxetine (Priligy) before you try it, and offer some alternatives to look at if you’re a resident of America. 

We’ll also cover the benefits of dapoxetine, what recent research says about the drug, and how to use it safely. 

What is Dapoxetine (Priligy)?

Dapoxetine is the chemical name for a drug called Priligy. It’s a prescription medication used to treat premature ejaculation (PE).

Before dapoxetine was developed, doctors would prescribe antidepressant SSRI medications to help with premature ejaculation because increased ejaculation latency was a common side effect of these drugs. 

However, antidepressants usually take several weeks before they start producing results, and can lead to issues with dependency over time and come with a host of negative side effects. 

Dapoxetine is used as an alternative to antidepressants due to its fast onset (within 1 hour), and short duration of effects (3 hours). These qualities dramatically reduce the chances of side effects and dependency. 

Is Priligy (Dapoxetine) Available in the United States?

No, Priligy has not yet been approved for sale in the United States. 

The owner of the medication (Johnson & Johnson) first applied for approval of the drug in 2004, and was denied early 2005 based on a lack of evidence to support the safety and efficacy of the drug. 

Since this time, there have been dozens of clinical trials and research articles published on the use of dapoxetine — which could mean the drug will be available in the near future. 

However, at the moment, it’s impossible to get ahold of dapoxetine legally in the United States, even with full support from your doctor.

The most common alternatives for Priligy include: 

  • SSRI Antidepressants
  • Topical Analgesics
  • Modafinil (Provigil) 
  • Silodosin (Rapaflo)
  • Behavioral Changes & Counseling

We cover each of these alternatives in greater detail later on in the article. 

Priligy is readily available in Canada, Australia, Mexico, and throughout most of Europe. 

How Long Does Dapoxetine (Priligy) Last? 

Dapoxetine is quickly absorbed by the body. Johnson & Johnson recommend taking the drug anywhere from 1 to 3 hours before sexual activity. The maximum effects of the drug are achieved between 1 and 2 hours after taking it. 

The effects of Dapoxetine will last roughly 3 hours, but in some cases can last up to 12 hours. The 60 mg dose lasts roughly 20% longer than the 30 mg dose. 

The half-life of the drug is just 1.4 hours, which means roughly 50% of the medication has already been eliminated from the body within 2 hours of taking it [5]. However, even at a dose of 50%, the drug still has a strong impact on the body. 

How Does Dapoxetine Work? 

Dapoxetine is classified as a selective serotonin reuptake inhibitor (SSRI). It blocks the reuptake of serotonin in the nerve cells which causes the concentration of serotonin to increase.

Serotonin is an important chemical messenger in the neurons used to regulate mood, appetite, digestion, and sexual stimulation. 

Once serotonin is released, it’s reabsorbed by the neuron and broken down. SSRI medications block the ability for the neurons to reabsorb serotonin — causing it to accumulate in the synapses. 

By elevating serotonin levels in synapses found in the brainstem (specifically LPGi neurons), the threshold required to achieve ejaculation is increased [4]. This means men taking SSRIs need to reach a higher level of arousal to ejaculate. 

There are many other SSRI medications on the market as well — but the primary use of these drugs is for treating depression. 

Serotonin has many uses in the body. It’s involved with regulating the mood (hence the use of these drugs for treating depression), but it’s also heavily involved with sexual function and ejaculation. 

Many SSRI antidepressants also work to prolong ejaculation, but they aren’t always a good option for people experiencing PE without depression. 

Dapoxetine works through the same mechanism to lengthen the amount of time before ejaculation occurs, and is also metabolized quickly from the body — dramatically reducing the development of tolerance, dependency, or other side effects. 

The History of Dapoxetine

Like many other medications in the sexual health space, dapoxetine was discovered by accident. 

Researchers at Eli Lilly — a large pharmaceutical company that also owns Cialis — were looking for a new antidepressant medication. 

Many antidepressants work by inhibiting the reuptake of serotonin (SSRI) — causing an upregulation of serotonin levels in the brain. Higher serotonin levels often lead to a better mood. 

However, dapoxetine was a poor antidepressant because of how fast it’s broken down by the body. The antidepressant effects only last around 3 hours which isn’t long enough to compete with drugs like Zoloft or Prozac — both of which last over 24 hours. 

However, Eli Lilly was in luck — one of the most common side effects of SSRI medications is delayed ejaculation. So the team at Eli Lilly decided to test if this effect could work with their new, now defunct, antidepressant. 

Prior to dapoxetine, there were no medications available for treating premature ejaculation, so people were using other medications off label to get a similar effect. The most common medications used off-label for PE were fluoxetine, fluvoxamine, citalopram, paroxetine, and sertraline — all of which are SSRI antidepressants. 

Researchers at Eli Lilly did a small animal study to see if the new drug could produce the same “side effects” — which, of course, it did. 

The same quality that makes dapoxetine a poor antidepressant (short duration of effect), makes it perfect for treating premature ejaculation. Patients could take the drug for its benefits on PE, which would last about 3 hours before wearing off completely. Making it much safer than taking one of the longer-lasting antidepressant medications. 

Eli Lilly eventually sold the drug to Johnson & Johnson, who quickly submitted patents to the FDA to protect their investment. These patents are still valid today, which means there are no generic versions of this drug available. 

Johnson & Johnson market the drug in the United States, Canada, and Japan. For the European, Asian, African, Latin American, and Middle Eastern regions, Johnson & Johnson have sold the rights to an Italian pharmaceutical company called Menarini.

Is Dapoxetine Safe?

Like any pharmaceutical drug, dapoxetine comes with a few inherent risks. 

The most common side effects of the drug are nausea. More serious side effects are also possible but are very rare. 

The larger 60 mg dose is much more likely to cause side effects, so doctors usually start with the smaller dose, and only increase to the 60 mg option if the 30 mg pill doesn’t work. 

Compared to other SSRI medications, which are sometimes used off-label for treating PE, dapoxetine is much less likely to result in dependency or other side effects because of its rapid metabolism in the body. 

Side Effects of Dapoxetine May Include:

  • Nausea
  • Diarrhea
  • Headache
  • Dizziness
  • Dry Mouth
  • Insomnia
  • Decreased libido (<1%)
  • Erectile Dysfunction (4%)

During phase III clinical testing, detailed documentation of each side effect was recorded for the 30 and 60 mg doses. The following chart shows a breakdown of how many patients experienced each of the most common side effects of the drug. 

This data is based on the treatment of dapoxetine in over 1200 men. 

Side Effect30 mg Dapoxetine60 mg Dapoxetine
Nausea8.7%20.1%
Diarrhea3.9%6.8%
Headache5.9%6.8%
Dizziness3.0%6.2%

In general, dapoxetine is considered safe for men between the ages of 18 and 64. Clinical trials involving the drug have noted a low dropout rate due to side effects.

In one study, involving 1067 patients, the dropout rate was 1.7% and 5.8% for the 30 and 60 mg treatment groups respectively [2].

Negative Drug Interactions With Dapoxetine

1. CYP3A4 Inhibitors

CYP3A4 refers to one of the many enzyme groups found in the liver. These enzymes are tasked with breaking down and metabolizing anything from medications, to hormones. 

Dapoxetine is specifically targeted by the CYP3A4 enzymes. If other medications that require the same metabolic pathway are used, they will compete with each other. This can cause metabolism to become slow, potentially leading to a buildup of both medications. 

It’s not wise to use dapoxetine if you’re taking other known medications that require this enzyme for metabolism. A few examples include: 

  • Ketoconazole
  • Ritonavir
  • Telithromycin

2. Selective Serotonin Reuptake Inhibitor (SSRI) Medications

Dapoxetine is technically an SSRI medication itself, even though it’s not used in the same way as most other SSRIs. 

If you mix dapoxetine with other SSRI medications used for depression or anxiety, both drugs will have a compound effect — potentially leading to serious side effects. 

3. Other Antidepressant Medications (MAO Inhibitors, Tricyclic Antidepressants, SNRIs)

Other antidepressants can also interact with dapoxetine because of the shared pathways these drugs have on the body.

SNRI medications (serotonin and norepinephrine reuptake inhibitors), tricyclic antidepressants, and MAO (monoamine oxidase) inhibitors all lead to an increase in serotonin levels in the brain. All of these medications are likely to interfere with dapoxetine if used together. 

Even after someone stops taking these medications, doctors will wait a minimum of 14 days to allow the drugs to clear the body completely before prescribing dapoxetine. 

Clinical Trials Involving Dapoxetine

Two randomized, double-blind, placebo-controlled, phase III trials were done in parallel at 121 different sites across the United States [1]. All the men in the study were diagnosed with premature ejaculation and were in stable heterosexual relationships.

The goal of these studies was to measure the intravaginal ejaculation latency time (IELT) — that is, the time it took from the start of intercourse to ejaculation. 

The study took place over 12-weeks, and men were given either 30 mg, 60 mg, or a placebo containing none of the active ingredients. 

The study found both treatment groups showed significant improvements in IELT compared to the placebo and worked on the first dose. The 60 mg group had the greatest impact of all.

Mean IELT30 mg Dapoxetine60 mg DapoxetinePlacebo
Average IELT Before the Trial0.9 Minutes0.92 Minutes0.91 Minutes
Average IELT During the Trial2.78 Minutes3.32 Minutes1.75 Minutes
Percent Improvement208.89%260.87%92.31%

*IELT refers to “intravaginal ejaculation latency time” — or the time it took from the initiation of intercourse to ejaculation. 

It’s reasonable to expect some change to occur simply by entering the study — as seen in the placebo control group. This concept is called the Pygmalion effect — which is a psychological phenomenon where having expectations that something will work leads to improvement. 

All three groups likely improved because of this effect, but the change in the treatment groups was significantly higher — which is a reliable indicator of improvement as a direct result of the drug. 

What is Premature Ejaculation? What’s The Cause?

Premature ejaculation is usually diagnosed if ejaculation occurs within one minute of intercourse, or less than three minutes on a consistent basis [7]. 

The average ejaculation time is around 5.5 minutes (based on data from over 500 couples). 

The Cause of Premature Ejaculation

There are a lot of causes for premature ejaculation, and some incidences of PE is completely normal. Roughly 1 in 3 men experience PE at least once.

The most common cause of PE is anxiety — usually about sexual performance itself when having sex with a new partner.

Potential causes for premature ejaculation include:

  • Anxiety around sexual performance
  • Thyroid problems
  • Prostate issues
  • Recreational drug use
  • Depression
  • Past traumas
  • Penile function (extra sensitivity)
  • Conditioning (masturbating to ejaculation too quickly)

Treating Premature Ejaculation Through Diet & Lifestyle

Fortunately, there are a few things you can do if you experience premature ejaculation on a regular basis before taking dapoxetine. 

The first step is to try and identify what’s causing the issue. The cause may not immediately be clear, but if there’s an obvious problem with the relationship, drug use, sexual performance anxiety, thyroid issues, or prostate dysfunction — that’s the best place to start. 

For those not sure what the cause is, try some of the techniques below. 

The most important part when dealing with premature ejaculation is to be patient, persistent, and open with your partner. 

1. Counseling

The most common cause of premature ejaculation is anxiety around sexual performance. This is the type of PE many men experience on the first sexual encounter with a woman. 

In most cases, PE will go away with future sessions, but in the event that it doesn’t, or PE occurs along with a long-term relationship, it may be a good idea to get some counseling to get to the root of the problem. 

Sexual health counseling is specialty of its own, and there are a lot of professionals with years of experience helping men through their problems to last longer in the bedroom. 

Couples therapy is another great way to address any issues they may have together and can highlight some techniques to help the male partner last longer in the bedroom.

This is a great place to start if you’re not sure what’s causing PE. 

2. Masturbate Prior to Having Sex

Sometimes, treating PE is as simple as masturbating about an hour or two prior to having sex. 

This reduces stimulation during intercourse to help men last longer. 

3. Pelvic Floor Exercises

A series of muscles located in the pelvic floor are responsible for controlling ejaculation. By strengthening the pelvic floor, tolerance may improve during intercourse to delay ejaculation. 

The best way to exercise the pelvic floor is through kegel exercises: 

Step 1: Find the Pelvic Floor Muscles

It’s important to identify the pelvic floor muscles and what they feel like before you start your exercises. A lot of men end up mistakenly flexing the abdominal muscles instead of the pelvic floor, which isn’t going to offer any benefit for premature ejaculation. 

The best way to find the pelvic floor muscles is to stop urinating mid-stream. The only way to do this is to flex the pelvic floor. 

Once you’re familiar with what muscles are involved, flexing them on your own is much easier. 

Step 2: Tighten the Pelvic Floor for a Few Seconds & Relax

You can exercise these muscles by continuing to stop urination mid-stream, or simply flex them while sitting or lying down. 

Tighten the muscles, hold for three seconds, and relax. Repeat this 3 – 6 times in a row. 

It helps to try these exercises in different positions during the day. Do some while sitting at your desk, standing, lying in bed, and walking. 

Step 3: Repeat Ten Times per Day, Everyday

Ideally, you should be doing these exercises every day, about ten times per day. 

Over time your pelvic floor muscle tone will improve and you may start to last longer int he bedroom. 

4. The Pause Squeeze Technique

The pause-squeeze technique should be done with your partner. This is a good way to train the body to last longer, but both partners need to be on-board for this to work. 

Here’s how it works: 

  1. Have sex as you normally would until you start to feel the urge to ejaculate — don’t wait too long
  2. Your partner will squeeze the head of your penis for several seconds until the urge to ejaculate goes away
  3. Repeat this process as many times as necessary

Another, simpler method is to simply stop all motion when you feel the urge, and wait for the sensation to pass. 

Over time, this technique can train the body to wait a longer period of time before ejaculation occurs. 

5. Condoms

Condoms reduce sensation during sex and can be a powerful tool to help you last longer. 

You can even buy specialty condoms that are designed to reduce sensation in the penis during sex. Extra thick condoms or condoms that contain topical numbing agents can be used to further reduce stimulation if normal condoms don’t do the trick. 

Look for Durex Performax Intense, Trojan Extended, or Lifestyles Everlast Intense.

Alternatives to Dapoxetine

If the above methods don’t quite work for you, there are plenty of medications that can help with ED as well — including dapoxetine. 

Dapoxetine is unavailable in the United States — so here are a few other medications you may be able to get a prescription for instead. 

1. SSRI Antidepressants

SSRI antidepressants have the same mechanism of action as dapoxetine. The only difference is that they stick around much longer in the body. 

Before dapoxetine was invented, SSRI medications were the standard for pharmaceutical PE treatment (off-label). 

A few examples of SSRI medication include:

  • Citalopram (Celexa)
  • Escitalopram (Lexapro)
  • Fluoxetine (Prozac)
  • Paroxetine (Paxil, Pexeva)
  • Sertraline (Zoloft)

You’ll need to get a prescription from your doctor to be able to order these medications. 

2. Erectile Dysfunction Medications (Viagra, Cialis, Levitra)

Erectile dysfunction drugs like viagra, cialis, and levitra are also used to treat premature ejaculation — however, none of these drugs are approved for this condition. 

ED drugs don’t work directly on ejaculation times — but they go a long way towards boosting confidence during sex, which may alleviate the most common cause of PE — sexual performance anxiety. 

The most popular ED medication is Viagra, but Cialis lasts the longest. 

You’ll need a prescription from your doctor to be able to get ahold of erectile dysfunction medications. 

3. Modafinil (Provigil, Nuvigil)

Modafinil is a stimulant drug used for a condition called narcolepsy — which involves excessive or sudden sleepiness. 

While it’s not clear exactly how modafinil works for this condition, studies have shown the drug can improve ejaculation latency time in Lifelong premature ejaculation [6] — which is a notoriously difficult form of PE to treat. 

Modafinil has not yet been approved for treating premature ejaculation and is a prescription-only medication. It’s up to your doctor’s discretion whether you will qualify for a modafinil prescription or not. 

4. Silodosin (Rapaflo)

Silodosin is a prescription medication for benign-prostatic hyperplasia (BPH) — a non-cancerous enlargement of the prostate gland. 

One of the main side effects of the drug is prolonged ejaculation latency. 

A recent study explored the reliability of using the drug to treat PE in patients that didn’t respond well to dapoxetine. Researchers concluded the trial by stating that “Silodosin, a drug that has already been proved safe for human use by its safety profile in the treatment of LUTS (Lower urinary tract symptoms), is a safe and better-tolerated alternative to dapoxetine in the management of premature ejaculation”.

You will need a prescription from your doctor to be able to buy silodosin. 

5. Topical Anesthetics

Topical anesthetics work by reducing sensation in the penis. They can be applied prior to intercourse to reduce stimulation and prolong ejaculation. 

You should apply topical anesthetics about 10 or 15 minutes before sex for best results. 

It’s important to only use anesthetics that have been approved for use during sex. Prescription creams such as Elma (lidocaine-prilocaine) are the most common. Benzocaine-based ointments and creams are also available under different names. 

The problem with topical anesthetics is that they may lead to too much numbing — blocking sensation in both the man and the women during intercourse. 

6. Natural Dapoxetine Alternatives

There are a few natural supplements often used to help with premature ejaculation. 

In general, the best supplements are herbs and nutrients that can help with underlying sexual anxiety or support the production of testosterone and other male androgens: 

  • Korean red ginseng (Panax ginseng)
  • Yohimbine (Pausinystalia johimbe)
  • Maca (Lepidium meyeni)
  • Rhodiola (Rhodiola rosea)
  • L-Arginine
  • DHEA

Where to Buy Dapoxetine

Dapoxetine is not available in the United States, but you can order the medication with a valid prescription if you live in Canada, or most of Europe. 

If you live in the United States, you won’t be able to get dapoxetine from any drug stores or online pharmacies. The only way to get the medication is to order it from online pharmacies located in regions where the drug can be sold legally — but you’ll still need a prescription to get it. 

In the US, doctors may prescribe other medications instead of dapoxetine, such as SSRIs, topical analgesics, modafinil, or silodosin if other lifestyle or behavioral treatments don’t work. 

References

  1. Pryor, J. L., Althof, S. E., Steidle, C., Rosen, R. C., Hellstrom, W. J., Shabsigh, R., … & Dapoxetine Study Group. (2006). Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials. The lancet, 368(9539), 929-937.
  2. McMahon, C., Kim, S. W., Park, N. C., Chang, C. P., Rivas, D., Tesfaye, F., … & Aquilina, J. (2010). Treatment of premature ejaculation in the Asia-Pacific region: results from a phase III double-blind, parallel-group study of dapoxetine. The journal of sexual medicine, 7(1), 256-268.
  3. Andersson, K. E., Mulhall, J. P., & Wyllie, M. G. (2006). Pharmacokinetic and pharmacodynamic features of dapoxetine, a novel drug for ‘on‐demand’ treatment of premature ejaculation. BJU international, 97(2), 311-315.
  4. Clément, P., Bernabé, J., Gengo, P., Denys, P., Laurin, M., Alexandre, L., & Giuliano, F. (2007). Supraspinal site of action for the inhibition of ejaculatory reflex by dapoxetine. European urology, 51(3), 825-832.
  5. McCarty, E. J., & Dinsmore, W. W. (2012). Dapoxetine: an evidence-based review of its effectiveness in treatment of premature ejaculation. Core evidence, 7, 1.
  6. Tuken, M., Kiremit, M. C., & Serefoglu, E. C. (2016). On-demand Modafinil Improves Ejaculation Time and Patient-reported Outcomes in Men With Lifelong Premature Ejaculation. Urology, 94, 139-142.
  7. Serefoglu, E. C., McMahon, C. G., Waldinger, M. D., Althof, S. E., Shindel, A., Adaikan, G., … & Giraldi, A. (2014). An evidence‐based unified definition of lifelong and acquired premature ejaculation: Report of the second International Society for Sexual Medicine Ad Hoc Committee for the Definition of Premature Ejaculation. The journal of sexual medicine, 11(6), 1423-1441.

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