Priligy

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Priligy on Prescriptsy

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Priligy is a brand name for dapoxetine, a short-acting selective serotonin reuptake inhibitor (SSRI) specifically developed for the on-demand treatment of premature ejaculation (PE) in men aged 18 to 64 years.

Unlike conventional SSRIs, which are taken daily for depression and anxiety, dapoxetine is designed to be taken only when needed, 1 to 3 hours before anticipated sexual activity.

Priligy is available as film-coated tablets in strengths of 30 mg and 60 mg. It is a prescription-only medicine (POM) in the United Kingdom, manufactured by Menarini.

This page provides a detailed clinical guide to Priligy, including how it works, dosage instructions, side effects, safety warnings, and how to obtain it in the United Kingdom.

Important safety information about Priligy

Before reading further, please note these essential safety points.

• Priligy must not be taken with antidepressants (SSRIs, SNRIs, TCAs, MAOIs) or other serotonergic medicines due to the risk of serotonin syndrome.
• Priligy may cause fainting (syncope). Stay well hydrated, avoid alcohol, and sit or lie down if you feel faint.
• A blood pressure check (lying and standing) is recommended before starting Priligy.
• Do not take Priligy more than once in 24 hours.
• Avoid alcohol on days when you take Priligy.

Understanding premature ejaculation

Premature ejaculation is the most common male sexual dysfunction, affecting approximately 20% to 30% of men at some point in their lives.

It is defined as persistent or recurrent ejaculation occurring with minimal sexual stimulation, before, on, or shortly after penetration and before the person wishes it, causing marked personal distress or interpersonal difficulty.

The International Society for Sexual Medicine (ISSM) defines lifelong PE as ejaculation that always or nearly always occurs within 1 minute of vaginal penetration from the first sexual experience, and acquired PE as a clinically significant reduction in ejaculatory latency time, often to 3 minutes or less, in a man who previously had normal ejaculatory control.

The causes of premature ejaculation are multifactorial and include neurobiological factors (variations in serotonin receptor sensitivity and serotonergic neurotransmission), psychological factors (anxiety, relationship stress, performance anxiety, conditioning), and, in some cases, underlying medical conditions (prostatitis, thyroid dysfunction, erectile dysfunction).

Lifelong PE is thought to have a predominantly neurobiological basis, with some men having a genetically determined lower ejaculatory threshold related to reduced serotonergic neurotransmission.

Acquired PE more commonly has identifiable psychological or medical contributing factors.

Premature ejaculation can significantly affect quality of life, self-esteem, intimate relationships, and mental health.

Despite its prevalence, many men do not seek help due to embarrassment or a belief that no effective treatment exists.

In reality, several effective treatments are available, including behavioural techniques, topical anaesthetics, psychosexual therapy, and dapoxetine.

How Priligy works

The ejaculatory reflex is a complex process coordinated by the central and peripheral nervous systems.

It involves afferent sensory signals from the genital region travelling via the pudendal nerve to the spinal ejaculatory centre, which then triggers the motor output leading to emission and expulsion.

This spinal reflex is modulated by descending pathways from the brainstem, particularly serotonergic neurons originating in the nucleus paragigantocellularis.

Serotonin (5-HT) acts at 5-HT2C receptors to inhibit the ejaculatory reflex, while activation of 5-HT1A receptors facilitates ejaculation.

Dapoxetine inhibits the serotonin transporter (SERT), blocking the reuptake of serotonin from the synaptic cleft.

This increases serotonin concentration at the synapse, enhancing serotonergic transmission at inhibitory 5-HT2C receptors and raising the ejaculatory threshold.

The net effect is improved voluntary control over ejaculation and a delay in the ejaculatory reflex.

Dapoxetine's pharmacokinetic profile distinguishes it from other SSRIs: it is rapidly absorbed (peak concentration within 1 to 2 hours), has a short elimination half-life (approximately 1.5 hours for the parent compound), and is rapidly cleared from the body.

This makes it suitable for on-demand rather than daily dosing and reduces the accumulation and persistent side effects associated with daily SSRIs.

Clinical evidence for Priligy

Dapoxetine has been evaluated in several large, multicentre, randomised, double-blind, placebo-controlled trials involving over 6,000 men with premature ejaculation.

The pivotal phase III trials demonstrated that dapoxetine 30 mg and 60 mg significantly increased the average intravaginal ejaculatory latency time (IELT) compared with placebo.

In the pooled analysis, mean IELT increased from approximately 0.9 minutes at baseline to approximately 3.0 minutes with dapoxetine 30 mg and approximately 3.5 minutes with dapoxetine 60 mg, compared with approximately 1.9 minutes with placebo.

Beyond IELT, dapoxetine significantly improved patient-reported outcomes, including perceived control over ejaculation, satisfaction with sexual intercourse, and reduction in personal distress and interpersonal difficulty related to PE.

The clinical benefit was evident from the first dose, and the effect was maintained throughout the study periods (up to 24 weeks).

Discontinuation rates due to adverse effects were low (approximately 4% with 30 mg, 10% with 60 mg).

The most common adverse events leading to discontinuation were nausea, dizziness, and headache.

The European Association of Urology (EAU) guidelines and the ISSM guidelines recognise dapoxetine as the only licensed on-demand oral treatment for premature ejaculation in many countries, including the UK.

Other pharmacological approaches include off-label daily SSRIs (paroxetine, sertraline, fluoxetine) and topical anaesthetic agents (lidocaine/prilocaine spray or cream).

Priligy compared with other PE treatments

Several treatment approaches are available for premature ejaculation.

Behavioural techniques, including the stop-start method (Semans technique) and the squeeze technique (Masters and Johnson), aim to help men recognise the sensation of approaching ejaculation and learn to delay it.

These can be effective but require consistent practice and the cooperation of a partner.

Psychosexual counselling or cognitive behavioural therapy (CBT) may address underlying psychological factors such as performance anxiety or relationship difficulties.

Topical anaesthetic agents, such as lidocaine/prilocaine cream or spray (Fortacin), reduce the sensitivity of the glans penis and can delay ejaculation.

They are applied 5 to 15 minutes before intercourse and may be used alone or in combination with other treatments.

Off-label daily SSRIs (paroxetine 20 mg, sertraline 50 mg, fluoxetine 20 mg) are sometimes prescribed for PE, taken daily rather than on demand.

These typically provide a greater increase in IELT than on-demand dapoxetine but carry the burden of daily medication and the full range of SSRI side effects, including sexual dysfunction, weight changes, and discontinuation symptoms.

Priligy offers the advantage of on-demand dosing (taken only when needed), rapid onset of action, rapid clearance from the body, and a side-effect profile that is generally milder and shorter-lasting than daily SSRIs.

The choice of treatment should be guided by the man's preferences, the nature and severity of PE, and any underlying contributing factors.

Dosage and administration

Take one Priligy tablet 1 to 3 hours before anticipated sexual activity. The recommended starting dose is 30 mg.

If the 30 mg dose does not provide adequate improvement after the first few uses and side effects are tolerable, your prescriber may increase the dose to 60 mg.

Do not take Priligy more than once in any 24-hour period. Swallow the tablet whole with at least one full glass of water.

Priligy can be taken with or without food.

Your prescriber should review the benefits and risks of Priligy after the first 4 weeks of treatment (or 6 doses, whichever comes first).

If Priligy is not providing clinically meaningful benefit, treatment should be discontinued. If treatment is continued, reassessment should occur at least every 6 months.

Avoid grapefruit juice while taking Priligy, as it inhibits CYP3A4 and may increase dapoxetine levels. Avoid alcohol, which increases the risk of dizziness, drowsiness, and fainting.

Side effects of Priligy

Common side effects

Nausea is the most frequently reported side effect, occurring in approximately 10% to 20% of men taking Priligy.

It is usually mild and can be reduced by taking the tablet with food and water. Dizziness and headache are also common. Diarrhoea, insomnia, and fatigue may occur.

Most side effects are transient and related to the peak plasma concentration of the drug.

Syncope and presyncope

Fainting (syncope) and near-fainting (presyncope) have been reported in clinical trials, with an incidence of approximately 0.1% to 1%.

These episodes are typically vasovagal, preceded by prodromal symptoms such as nausea, dizziness, lightheadedness, sweating, and pallor.

Risk factors include dehydration, fasting, alcohol, heat exposure, and concomitant antihypertensive medication.

To reduce the risk, stay well hydrated, avoid alcohol, avoid taking Priligy on an empty stomach if nausea has been a problem, and sit or lie down at the first sign of feeling faint.

Mood and psychiatric effects

Mood changes, including anxiety, irritability, and restlessness, may occur.

Although dapoxetine is used on demand rather than daily, it shares the SSRI class and therefore carries a theoretical risk of the psychiatric effects associated with SSRIs.

Men with a history of depression, bipolar disorder, or suicidal ideation should be carefully assessed before being prescribed Priligy.

Serotonin syndrome

Serotonin syndrome is a rare but potentially life-threatening condition caused by excessive serotonergic activity.

Symptoms include agitation, confusion, rapid heart rate, labile blood pressure, hyperthermia, sweating, diarrhoea, muscle rigidity, myoclonus (jerky movements), and clonus.

It is most likely to occur when dapoxetine is combined with other serotonergic agents. If symptoms develop, stop all serotonergic medicines and call 999 immediately.

When to seek medical advice

Stop Priligy and seek urgent medical advice if you experience fainting, seizures, chest pain, severe dizziness, signs of serotonin syndrome, or significant mood changes.

Call 999 in an emergency. Report suspected adverse reactions to the MHRA via the Yellow Card scheme at yellowcard.mhra.gov.uk .

Warnings and precautions

Contraindications

Priligy is contraindicated in men with significant cardiac disease (heart failure, conduction abnormalities, significant ischaemic heart disease, significant valvular disease), a history of syncope, moderate or severe hepatic impairment, concurrent or recent use (within 14 days) of MAOIs, concurrent or recent use (within 7 days) of SSRIs, SNRIs, TCAs, or thioridazine, and known hypersensitivity to dapoxetine or any excipient.

Orthostatic assessment

Before prescribing Priligy, an orthostatic test should be performed: measure blood pressure lying down and then standing. If there is a significant postural drop or a history of orthostatic hypotension, Priligy should not be prescribed.

Serotonergic medicines

Priligy must not be combined with any other serotonergic medicine, including SSRIs, SNRIs, TCAs, MAOIs, triptans (used for migraine), tramadol, St John's wort (hypericum), lithium, or tryptophan. A washout period is essential when switching between these medicines and dapoxetine.

CYP enzyme inhibitors

Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir and other HIV protease inhibitors) are contraindicated with Priligy.

Moderate CYP3A4 inhibitors (erythromycin, clarithromycin, fluconazole, verapamil, diltiazem) and CYP2D6 inhibitors (fluoxetine, paroxetine) require dose limitation to 30 mg. Known CYP2D6 poor metabolisers should not exceed 30 mg.

Alcohol

Alcohol increases the risk of adverse neurological effects (dizziness, drowsiness) and syncope when combined with dapoxetine. Patients should avoid alcohol on days when they take Priligy.

Recreational drugs

MDMA (ecstasy), cocaine, and other recreational drugs with serotonergic or cardiovascular effects may interact dangerously with dapoxetine. The combination carries a risk of serotonin syndrome, severe hypertension, and cardiac arrhythmias. Patients should be warned.

Not for use in women or children

Priligy is licensed for use in men aged 18 to 64 years only. It is not indicated for women or for men outside this age range.

Seeking help for premature ejaculation

Premature ejaculation is a common and treatable condition.

Many men find it difficult to raise the topic with a healthcare professional, but GPs, sexual health clinics (GUM clinics), and online prescribing services are experienced in discussing sexual health concerns confidentially and without judgement.

A consultation will typically involve questions about the duration and severity of PE, its impact on your life and relationships, your general health, and any medicines you are taking.

Treatment can be highly effective, and combining pharmacological and behavioural approaches often produces the best results.

How to get Priligy in the UK

Priligy is available on private prescription from your GP, a sexual health clinic, or an authorised online prescriber registered with the General Pharmaceutical Council (GPhC) and the Care Quality Commission (CQC).

Priligy is not routinely prescribed on the NHS. The cost varies between providers.

Ensure that any online prescribing service requires a genuine medical consultation (including questions about your medical history, current medicines, and suitability for treatment) before issuing a prescription.

Avoid unregistered websites that offer to sell medicines without a consultation, as these are illegal and may supply counterfeit or unsafe products.

Sources

• Priligy 30 mg and 60 mg Film-Coated Tablets, Summary of Product Characteristics (EMC)
• Dapoxetine, British National Formulary (BNF)
• Ejaculation problems, NHS
• International Society for Sexual Medicine
• MHRA Yellow Card Scheme