Priligy 30mg vs 60mg: What the Trial Data Shows

Choosing Between the Two Priligy Doses and When to Change

  • The 30 mg and 60 mg figures side by side, taken from the trial data rather than from a product page
  • The one circumstance in which guidance rules out moving to the higher dose, which almost no page mentions
  • What the orthostatic test before starting is, and why it exists
  • An online consultation with UK registered prescribers, with clinical assessment before anything is supplied

The difference between Priligy 30 mg and 60 mg is measurable, but it is not simply a case of “more is better”. In the clinical trial data, mean intravaginal ejaculatory latency time (IELT) at 12 weeks was 3.1 minutes with 30 mg and 3.6 minutes with 60 mg. At the same time, some adverse effects were more common with the higher dose, including nausea, dizziness and syncope.

Dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI) used on demand for premature ejaculation. Both strengths showed benefit compared with placebo in clinical trials, but the choice of dose needs to take account of the individual's response, medical history, other medicines and risk factors.

This guide explains what the trial figures actually show, why 30 mg is the recommended starting dose, and the specific situation in which guidance says the dose should not be increased to 60 mg.

Key things to know

  • Mean intravaginal ejaculatory latency time at 12 weeks was 1.9 minutes on placebo, 3.1 minutes on 30 mg and 3.6 minutes on 60 mg, from a baseline of 0.9 minutes in every arm.
  • Nausea affected 2.2 per cent on placebo, 11.0 per cent on 30 mg and 22.2 per cent on 60 mg.
  • Dizziness affected 2.2 per cent on placebo, 5.8 per cent on 30 mg and 10.9 per cent on 60 mg.
  • Syncope occurred 0.05 per cent on placebo, 0.06 per cent on 30 mg and 0.23 per cent on 60 mg.
  • The recommended starting dose for all men is 30 mg, and treatment should not be initiated with the 60 mg dose.
  • Where a man has an orthostatic reaction on the 30 mg dose, guidance states the dose should not be increased to 60 mg.
  • An orthostatic test, measuring blood pressure and pulse rate lying and standing, is described as part of the examination before starting.
  • No schedule for changing dose appears on this page, because publishing one would be a titration plan rather than information.

Priligy 30mg vs 60mg: what the trial data shows

Both strengths were tested against placebo in randomised controlled trials, and both beat it. The interesting part is the size of the gap between them.

Intravaginal ejaculatory latency time, usually shortened to IELT, is the measure used as the primary outcome in these trials. It is a stopwatch measurement rather than an impression, which is what makes the comparison worth reading. Dapoxetine for premature ejaculation is prescribed as an on demand treatment, typically taken one tablet 1 to 3 hours before intercourse to provide better control.

Dapoxetine is taken on demand rather than every day. The recommended dosing instructions specify taking the tablet approximately 1 to 3 hours before anticipated sexual activity.

The efficacy figures side by side

Measure at 12 weeks Placebo 30 mg dose 60 mg dose
Baseline IELT 0.9 minutes 0.9 minutes 0.9 minutes
Mean IELT at 12 weeks 1.9 minutes 3.1 minutes 3.6 minutes
Gain over baseline 1.0 minute 2.2 minutes 2.7 minutes
Gain over placebo Not applicable 1.2 minutes 1.7 minutes

Both dapoxetine arms reached statistical significance against placebo. The difference between the two strengths is 0.5 minutes.

What the higher dose costs

The higher dose does not simply provide more benefit without adding risk. In the clinical trials, several adverse effects were more common with 60 mg than with 30 mg.

Nausea increased from 11.0% to 22.2%, while dizziness increased from 5.8% to 10.9%. Syncope was uncommon but occurred more often with 60 mg than with 30 mg.

The adverse events table

Adverse effect Placebo 30 mg dose 60 mg dose
Nausea 2.2% 11.0% 22.2%
Dizziness 2.2% 5.8% 10.9%
Syncope, including loss of consciousness 0.05% 0.06% 0.23%

Nausea doubles. Dizziness nearly doubles. Syncope remained uncommon, but the reported rate was higher with 60 mg.

Setting benefit and harm beside each other

Moving from 30 mg to 60 mg Change
Mean IELT Up 0.5 minutes
Nausea Roughly doubled
Dizziness Roughly doubled
Syncope Roughly quadrupled

Guidance states plainly that the incidence and severity of adverse events is higher with the 60 mg dose. The table above is what that sentence looks like with numbers attached.

The starting position guidance sets

The recommended starting dose for all men is 30 mg. Treatment should not be initiated with the 60 mg dose.

That is not a preference and it is not a cost saving measure. It is a stated position in the guidance covering dapoxetine treatment, and it applies to everybody regardless of how severe the problem feels.

When moving up is ruled out

This is the section that answers the question most people arrive with, and it has a definite answer rather than a hedge.

Guidance states that if a man has an orthostatic reaction on the 30 mg dose, the dose should not be increased to 60 mg.

What an orthostatic reaction means

Orthostatic means relating to standing. An orthostatic reaction can involve a drop in blood pressure after standing and may cause symptoms such as light-headedness or feeling faint. NICE's evidence summary states that patients should be counselled about these warning symptoms because dapoxetine can cause orthostatic hypotension and syncope

Why this rule exists

The lower strength already produced dizziness in 5.8 per cent of men. The precaution is important because orthostatic reactions and syncope are recognised risks with dapoxetine, and adverse events are generally more frequent with the 60 mg dose. NICE therefore specifically states that a man who has an orthostatic reaction on 30 mg should not have the dose increased to 60 mg

What to do if this is you

Report it. A prescriber cannot apply a rule they have not been told the facts for, and an orthostatic reaction is not something to work around quietly.

The honest outcome may be that the lower strength is where treatment stays, or that a different route suits better. Both of those are results rather than failures.

The orthostatic test before starting

Before dapoxetine is started, the product information described by NICE recommends a careful medical examination, including a history of previous orthostatic events. An orthostatic test is also recommended, with blood pressure and pulse measured while lying down and again while standing.

The purpose is to identify factors that could increase the risk of dizziness, low blood pressure on standing or fainting. Patients should also be told about warning symptoms such as light-headedness after standing.

Two blister packs of capsules on a pink background

Who dapoxetine is not for

Dapoxetine is licensed for the on-demand treatment of premature ejaculation in adult men who meet the criteria for the licensed indication.

It is not intended as a medicine for enhancing sexual performance in men who do not have premature ejaculation. A prescriber needs to establish whether the symptoms fit the indication and whether dapoxetine is medically appropriate

Cardiac contraindications

Dapoxetine is contraindicated in men with significant pathological cardiac conditions such as heart failure, significant ischaemic heart disease, or a history of syncope.

A previous fainting episode is on that list in its own right. It is not a detail to leave out because it happened years ago.

Liver and kidney

The medicine is contraindicated in men with moderate and severe hepatic impairment.

For the kidneys, it should be used with caution in men with mild or moderate renal impairment, and it is not recommended for use in men with severe renal impairment. Liver and kidney health both belong in the assessment for that reason.

Psychiatric history

Among the contraindications is a history of mania or of severe depression, including major depressive disorder.

Psychiatric disorders are carefully considered because they can affect treatment safety and effectiveness. Men with a history of severe mental health conditions should inform their healthcare provider to ensure dapoxetine is suitable for them.

Disclosing psychiatric history does not automatically exclude someone from treatment, but withholding this information limits the prescriber's ability to make safe and effective decisions tailored to the individual's health profile.

Age

The efficacy and safety of dapoxetine have not been established in men aged 65 years and over.

Not established is different from being shown to be unsafe. It means the evidence to support use in that group is absent, which is a reason for caution rather than a reassurance.

Other medicines, alcohol and what must not be combined

Several combinations are contraindicated outright, and this is where a dose question most often turns out to be the wrong question.

The contraindicated combinations

Concomitant treatment with thioridazine, monoamine oxidase inhibitors, other SSRIs, tricyclic antidepressants, or other herbal and medicinal products with serotonergic effects is contraindicated. So is concomitant treatment with potent CYP3A4 inhibitors.

Dapoxetine should also not be used in men taking phosphodiesterase type 5 inhibitors, the class used for erectile dysfunction, with sildenafil given as the example. Where an erectile problem is also in play, the available erectile dysfunction treatments are assessed on their own terms before the two are ever considered together.

Why herbal products are on that list

The wording covers herbal and medicinal products with serotonergic effects, which is a category rather than a named list.

People routinely leave herbal products off a medicine list because they do not think of them as medicines. That is precisely the omission this contraindication is written to catch.Some herbal and medicinal products can have serotonergic effects and may interact with dapoxetine. St John's Wort is an example that should be disclosed to the prescriber. Tell your clinician about herbal products and supplements as well as prescription and non-prescription medicines so potential interactions can be assessed.

This is especially critical in the UK, where guidelines recommend thorough medication reviews before prescribing treatments for premature ejaculation to avoid harmful interactions.

By including herbal products in the contraindication list, the guidance ensures that all serotonergic substances are considered, protecting patients from unexpected side effects and promoting safer treatment outcomes..

Alcohol, and why it stacks with this medicine

Guidance advises men to avoid alcohol and not to use dapoxetine in combination with recreational drugs.

Alcohol can increase dizziness and impair judgement and coordination, while dapoxetine itself can cause dizziness and syncope. The product information therefore advises avoiding alcohol while taking dapoxetine.

Patients are also advised to disclose all current medications, including herbal supplements such as St. John's Wort, which can interact with dapoxetine and increase the risk of serotonin syndrome. Tell your prescriber about grapefruit or grapefruit juice and any other medicines you use, particularly medicines that may affect CYP3A4, because these can alter dapoxetine exposure.

What this page will not tell you

This page does not provide a personal schedule for increasing or changing your dapoxetine dose.

That is deliberate. A dose decision depends on factors such as how you responded to 30 mg, whether you experienced dizziness or an orthostatic reaction, what other medicines you take and whether you have relevant heart, liver or kidney problems.

Questions about changing dose, repeating a dose or altering a tablet should be discussed with your prescriber or pharmacist and checked against the patient information leaflet supplied with your medicine.

The questions this refusal covers

  • How long to try the lower strength before asking about the higher one
  • What counts as an insufficient response
  • Whether to take a second tablet when the first seemed not to work
  • Whether to split a tablet to try a smaller amount
  • How many doses are acceptable in a day

Every one of those is answered by the prescriber who assessed you and by the patient information leaflet supplied with your pack, not by a page written for everybody at once.

How a dose review with a prescriber actually works

A dose review looks at how you responded to the medicine, whether you experienced side effects, whether anything has changed in your health or other medicines, and whether the treatment is still appropriate.

The trial data can help put the two strengths into context: the mean IELT was 3.1 minutes with 30 mg and 3.6 minutes with 60 mg at 12 weeks, while several adverse effects were more common with the higher dose.

The decision about whether to remain on 30 mg, consider 60 mg or stop treatment altogether needs to be made by the prescriber based on the individual assessment.

Going back down is a real option

Moving to the lower strength after trying the higher one is a legitimate outcome, and it is the one most people never consider because the conversation is usually framed as upward only.

If 60 mg is not tolerated or is not considered appropriate, the prescriber may decide that 30 mg is more suitable or that another treatment should be considered.

Getting your dose reviewed

An assessment establishes whether either strength suits you and, if you are already taking one, whether the one you are on is still the right one.

It covers when the pattern began, any change in erectile function, urinary or prostate symptoms, every current medicine including any antidepressant by name, cardiac history including any episode of fainting or an orthostatic event, mental health history including mania or severe depression, liver and kidney health, and alcohol and recreational drug use.

That whole list is worked through by an online consultation with UK registered prescribers before anything is supplied. Priligy tablets carry a standard price of £19.79 on the product page, and that figure is the regular price rather than a first order or discounted rate.

Medical Disclaimer

This page provides general information and is not a substitute for individual medical advice. Dapoxetine is a prescription-only medicine in the UK, and any decision about starting, stopping or changing the dose should be made with an appropriately qualified prescriber.

Read the patient information leaflet supplied with your medicine and tell your prescriber about all medicines, supplements and relevant medical conditions.

Seek urgent medical attention if you faint, develop chest pain, have a seizure or experience a significant change in mood or thoughts of self-harm.

Frequently Asked Questions

Is Priligy 60mg better than 30mg?
The trial data shows a modest additional benefit with 60 mg, but also more adverse effects. Mean IELT at 12 weeks was 3.1 minutes with 30 mg and 3.6 minutes with 60 mg. Nausea occurred in 11.0% and 22.2%, respectively, while syncope remained uncommon but was reported more often with 60 mg.
Which Priligy dose should I take?
That is decided by the prescriber who assessed you, using your orthostatic response, cardiac history, other medicines and liver and kidney function. The recommended starting dose for all men is 30 mg.
What is the Priligy starting dose?
30 mg. Guidance states the recommended starting dose for all men is 30 mg and that treatment should not be initiated with the 60 mg dose.
Why can treatment not start at the higher dose?
Treatment is not started at 60 mg because 30 mg is the recommended starting dose and the higher dose is associated with a higher frequency of adverse events. NICE's evidence summary specifically states that treatment should not be initiated with 60 mg.
When should I move up to the higher Priligy dose?
That is a prescriber's decision and no timetable appears on this page. What guidance does state is a circumstance in which moving up is ruled out: if a man has an orthostatic reaction on the 30 mg dose, the dose should not be increased to 60 mg.
What is an orthostatic reaction?
A drop in blood pressure on standing. The warning signs, described as prodromal symptoms, are light headedness or feeling unsteady shortly after getting to your feet, and they can precede a faint.
My Priligy dose does not feel strong enough. What now?
Raise it at a dose review rather than acting on it yourself. Report exactly what happened, any light headedness or nausea, and any change in your other medicines, and let the prescriber weigh the 0.5 minute gain against the adverse effect figures for you.
How long should I try Priligy before changing dose?
No timetable is published here, because that is part of the prescriber's judgement. The trials ran mostly 12 or 24 weeks, and guidance notes limited data on use beyond 24 weeks.
Can I take two Priligy tablets at once?
No. Do not take more than the prescribed dose. If you think the medicine has not worked, do not take an additional tablet without speaking to your prescriber or pharmacist. Follow the dosing instructions in the patient information leaflet supplied with your medicine.
Can I split a Priligy tablet?
Do not split, crush or otherwise alter the tablet unless the product information or a pharmacist specifically confirms that it is appropriate.
What is the maximum recommended dose?
60 mg is described in guidance as the maximum recommended dose. That is a ceiling rather than a target, and reaching it is a clinical decision rather than a progression everybody makes.
What are the most common side effects?
Across the trials, nausea affected 11.0 per cent on 30 mg and 22.2 per cent on 60 mg, and dizziness 5.8 per cent and 10.9 per cent respectively. Headache is also commonly reported. Placebo rates for nausea and dizziness were 2.2 per cent each.
How likely is fainting on dapoxetine?
Syncope, including loss of consciousness, occurred in 0.05 per cent of men on placebo, 0.06 per cent on 30 mg and 0.23 per cent on 60 mg. It is the reason cardiac history, blood pressure and any previous faint are all part of the assessment.
Why is a blood pressure test done before starting?
An orthostatic test measuring blood pressure and pulse rate lying and standing is described as part of the examination before initiating therapy. It gives a baseline and identifies men who already drop on standing.
Can I drink alcohol while taking dapoxetine?
The product information advises avoiding alcohol while taking dapoxetine. Alcohol can itself contribute to dizziness and impaired coordination, while dapoxetine can cause dizziness and syncope.
Does grapefruit juice matter?
Tell your prescriber if you regularly drink grapefruit juice or take medicines that affect CYP3A4. Some CYP3A4 inhibitors can increase dapoxetine exposure, which is why potent CYP3A4 inhibitors are contraindicated.
Which medicines must not be combined with it?
Medicines that should not be combined with dapoxetine include MAOIs, other SSRIs, tricyclic antidepressants, thioridazine, potent CYP3A4 inhibitors and PDE5 inhibitors. Certain serotonergic herbal or medicinal products may also be contraindicated. Tell your prescriber about every medicine and supplement you take.
Can I take it if I have a heart condition?
Dapoxetine is contraindicated in men with significant pathological cardiac conditions such as heart failure, significant ischaemic heart disease, or a history of syncope.
What about liver or kidney problems?
It is contraindicated in moderate and severe hepatic impairment. For the kidneys it should be used with caution in mild or moderate renal impairment and is not recommended in severe renal impairment.
Is it suitable for people over 65?
The efficacy and safety of dapoxetine have not been established in men aged 65 years and over. That is an absence of evidence rather than a finding of harm, and it is a reason for caution.
Can I go back down to the lower dose?
If you do not tolerate 60 mg or your prescriber decides that the higher dose is not appropriate, they may recommend returning to 30 mg or considering another treatment.
How many men stop taking it?
Across the trials, discontinuation was 31.1% with dapoxetine and 28.9% with placebo. If you want to stop treatment because of side effects, lack of benefit or any other concern, discuss this with your prescriber.
Do both strengths actually work?
Both doses produced statistically significant improvements compared with placebo on the primary outcome in the pooled analysis. The clinical question is whether the additional benefit seen with 60 mg is appropriate for the individual given its adverse-effect profile.

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