Menarini Farmaceutica Internazionale: personal communication January 2014). The manufacturer further estimates that 25% of the men severely affected by premature ejaculation will seek treatment and 70% of those seeking treatment could be prescribed dapoxetine. The manufacturer therefore estimates that based on a GP-registered population of 100,000, 202 men aged 18 to 64 may potentially be prescribed dapoxetine over a 5-year period (A.
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A prospective observational study from a single clinical centre in Italy (Mondaini et al. 2013) assessed the acceptance and discontinuation rates of 'on demand' dapoxetine 30 mg (titrated to 60 mg after 3 months if low efficacy) in 120 men with lifelong premature ejaculation. Twenty-four (20%) of the men decided not to start dapoxetine. Fear of using a 'drug' was the most frequently reported reason for treatment non-acceptance (50%). In addition, the majority of men who took dapoxetine discontinued treatment. Menarini Farmaceutica Internazionale: personal communication January 2014). The manufacturer estimated that in 2013 approximately 75% of European sales of dapoxetine were for the 30 mg strength. Dapoxetine for premature ejaculation was not considered appropriate for a NICE technology appraisal and is not currently planned into any other work programme. There is no NICE guidance on premature ejaculation. A. Menarini Farmaceutica Internazionale (2013) Priligy 30 mg and 60 mg film-coated tablets summary of product characteristics [online; accessed 12 March 2014] Buvat J, Tesfaye F, Rothman M et al. (2009) Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries. European Association of Urology (2014) Guidelines on male sexual dysfunction [online; accessed 11 April 2014] Kaufman JM, Rosen RC, Mudumbi RV et al.
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However, some men may prefer to take a daily dose which may allow more spontaneity than a planned 'on demand' treatment. Dapoxetine is licensed for treating premature ejaculation in adult men aged 18 to 64 years. The summary of product characteristics states that dapoxetine should only be prescribed to men who meet all the following criteria: An intravaginal ejaculatory latency time of less than 2 minutes and An intravaginal ejaculatory latency time of less than 2 minutes and Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the man wishes and Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the man wishes and Marked personal distress or interpersonal difficulty as a consequence of premature ejaculation and Marked personal distress or interpersonal difficulty as a consequence of premature ejaculation and A history of premature ejaculation in the majority of intercourse attempts over the prior 6 months. Therefore, men will need to be appropriately assessed and given a diagnosis of premature ejaculation in line with the above criteria before dapoxetine can be considered. In addition, the summary of product characteristics states that a careful appraisal of the individual benefit/risk ratio should be carried out after the first 4 weeks of treatment (or at least after 6 doses of treatment) to determine whether continuing treatment is appropriate. (2009) Treatment benefit of dapoxetine for premature ejaculation: results from a placebo-controlled phase III trial.
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If dapoxetine is continued, the benefit/risk balance should be re-evaluated at least every 6 months. Consideration will need to be given to how treatment efficacy can be assessed given the subjective nature of efficacy outcomes. Premature ejaculation can occur in conjunction with erectile dysfunction and the European Association of Urology 2014 guidelines on male sexual dysfunction states that if premature ejaculation is secondary to erectile dysfunction then the erectile dysfunction should be treated before or at the same time as the premature ejaculation. It should be noted however, that the summary of product characteristics states that dapoxetine should not be used in men taking phosphodiesterase type 5 inhibitors (for example, sildenafil) as this increases the risk of syncope. For a number of men pharmacological treatment of premature ejaculation will not be acceptable. (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: 256–68 McMahon CG, Althof SE, Kaufman JM et al. (2011) Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials. (2014) Results from a prospective observational study of men with premature ejaculation treated with dapoxetine or alternative care: The PAUSE study.
2.6 Use in Specific Populations
The main reasons for treatment discontinuation were efficacy below expectations, side effects and costs. Out of the 96 men who decided to start dapoxetine, only 10 men were continuing the treatment after 1 year. Dapoxetine is the only medicine licensed in the UK for the treatment of premature ejaculation, although other treatments are used off-label for this indication. The General Medical Council advice to use a licensed medicine whenever possible should be taken into consideration. The manufacturer has estimated that based on a GP-registered population of 100,000 people, 5851 men aged 18 to 64 will be affected by premature ejaculation with 1151 men severely affected (A. (2013) Dapoxetine treatment in patients with lifelong premature ejaculation: the reasons of a 'Waterloo'. (2006) Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomized controlled trials Lancet 368: 929–37 The integrated process statement sets out the process NICE uses to select topics for the evidence summaries: new medicines and how the summaries are developed, quality assured and approved for publication. Ian Pearce, Consultant Urological Surgeon, Honorary Senior Lecturer, University of Manchester, Manchester Royal Infirmary Mike Foster, Consultant Urologist, Heart of England NHS Trust Peer reviewed by Sid DajaniLast updated by Michael Stewart, MRPharmSLast updated 14 Apr 2025 Dapoxetine is prescribed for the treatment of premature ejaculation. Take one tablet 1-3 hours before you have sex. The most common side-effects include feeling dizzy or faint, and feeling sick (nausea). Drinking a full glass of water at the same time as taking the tablet can reduce these effects. Premature ejaculation is the term used when a man orgasms (ejaculates) more quickly than he and/or his partner would like. For some men it can be temporary and can get better on its own; for others, prescribed treatments such as dapoxetine tablets can be helpful. Dapoxetine is a selective serotonin reuptake inhibitor medicine which has been specially developed for the treatment of premature ejaculation. It increases the time it takes to ejaculate and can improve the control over the ejaculation. It starts to work very quickly, so it is taken when you anticipate having sex, rather than every day. You have to take it 1-3 hours before you have sex. Some medicines are not suitable for people with certain conditions, and sometimes a medicine can only be used if extra care is taken. For these reasons, before you start taking dapoxetine it is important that your doctor knows: If you have a tendency to faint. If you have a tendency to faint. If you have a bleeding or clotting disorder. If you have ever had a mental health problem causing 'high' or 'low' moods, such as bipolar disorder, depression or mania. If you have increased pressure in your eye, a condition called glaucoma. If you have any problems with the way your liver works, or if you have any problems with the way your kidneys work. If you have ever had an allergic reaction to a medicine. If you are taking any other medicines. This includes any medicines which are available to buy without a prescription, as well as herbal and complementary medicines. Before you start the treatment, read the manufacturer's printed information leaflet from inside the pack. It will give you more information about dapoxetine, and will also provide you with a full list of the side-effects which you could experience from taking it. Take dapoxetine exactly as your doctor tells you to. Drink a full glass of water at the same time as you take a tablet. The recommended starting dose is one 30 mg tablet, taken 1 to 3 hours before you anticipate having sex. Your doctor may later decide to increase your dose to one 60 mg tablet. Your doctor will only prescribe the higher dose for you if the 30 mg dose is insufficient, and providing you have not experienced any side-effects such as feeling faint. Do not take more than one tablet in any 24 hours. Dapoxetine is not intended for regular daily use - you should only take it before you anticipate having sex. The tablet has a bitter taste, so swallow it whole without chewing. You can take it either with or without food. Make sure you keep your follow-on appointments with your doctor. This is so your doctor can check on your progress. Do not drink alcohol whilst taking dapoxetine, as it might increase the sedative effects of the alcohol. It can also increase the risk of fainting. Do not use any recreational drugs while you are taking dapoxetine, as this could lead to you experiencing serious side-effects. A chemical in grapefruit juice can increase the amount of dapoxetine in your bloodstream and this increases the risk of side-effects. If you do drink grapefruit juice, do not take a dapoxetine tablet for at least 24 hours afterwards. Take care if you are a driver. If you feel faint or dizzy, do not drive and do not use tools or machines. If you buy any medicines, please check with your doctor or a pharmacist that they are suitable for you to take with dapoxetine.