{"id":200,"date":"2026-10-31T10:28:05","date_gmt":"2026-10-31T10:28:05","guid":{"rendered":"https:\/\/yourmedsuk.com\/insights\/?p=200"},"modified":"2026-11-02T17:56:34","modified_gmt":"2026-11-02T17:56:34","slug":"modafinil-pregnancy-contraception","status":"publish","type":"post","link":"https:\/\/yourmedsuk.com\/insights\/modafinil-pregnancy-contraception\/","title":{"rendered":"Modafinil and pregnancy: birth defect risk, contraception and breastfeeding"},"content":{"rendered":"<div class=\"ym-article\">\n<p class=\"ym-answer\">Modafinil and pregnancy do not mix: UK guidance says modafinil should not be used during pregnancy because it may raise the chance of birth defects. It can also make hormonal contraception, including the pill, less effective. If you could get pregnant, you need effective contraception while taking it and for two months after stopping.<\/p>\n<div class=\"ym-facts\">\n<h2>Key facts<\/h2>\n<ul>\n<li><strong>What it is:<\/strong> A wakefulness-promoting medicine.<\/li>\n<li><strong>Licensed use (UK):<\/strong> Excessive sleepiness associated with narcolepsy, with or without cataplexy, in adults.<\/li>\n<li><strong>Legal status:<\/strong> Prescription-only medicine (POM).<\/li>\n<li><strong>Needs a prescription:<\/strong> Yes<\/li>\n<li><strong>Last checked:<\/strong> October 2026<\/li>\n<\/ul>\n<\/div>\n<p>This guide explains what the UK medicines regulator says about modafinil, pregnancy and contraception. It covers the evidence, which contraceptive methods still work, and what to do if you are planning a baby or find out you are pregnant. For an overview of the medicine, read our <a href=\"https:\/\/yourmedsuk.com\/insights\/modafinil\/\">complete guide to modafinil<\/a>.<\/p>\n<h2 id=\"why-not-in-pregnancy\">Why modafinil is not used in pregnancy<\/h2>\n<p>In November 2020 the <a href=\"https:\/\/www.gov.uk\/drug-safety-update\/modafinil-provigil-increased-risk-of-congenital-malformations-if-used-during-pregnancy\">MHRA issued a Drug Safety Update<\/a> on modafinil in pregnancy. It said modafinil potentially increases the risk of congenital malformations, which are problems with how a baby&#8217;s body forms before birth.<\/p>\n<p>The malformations reported included heart defects, hypospadias (where the opening of the penis is not at the tip) and cleft lip or palate. The MHRA&#8217;s advice is that modafinil should not be used in pregnancy. It asks doctors to consider other narcolepsy treatments instead.<\/p>\n<p>The <a href=\"https:\/\/www.medicines.org.uk\/emc\/product\/4319\/smpc\">UK Summary of Product Characteristics (SmPC) for modafinil<\/a> says the same. It states that modafinil is suspected to cause congenital malformations and should not be used during pregnancy.<\/p>\n<h2 id=\"evidence\">What the evidence shows<\/h2>\n<p>The warning is based mainly on a US pregnancy registry. This is a study that follows women who took modafinil or armodafinil (a closely related medicine) around the time of pregnancy. The MHRA&#8217;s <a href=\"https:\/\/www.gov.uk\/government\/news\/sleep-disorder-drug-modafinil-linked-to-increased-risk-of-birth-defects-and-also-to-reduced-effectiveness-of-contraception\">press release<\/a> summed it up as an approximate 15% chance of birth defects, compared with 3% in the general population.<\/p>\n<table>\n<thead>\n<tr>\n<th>Source<\/th>\n<th>What it found<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Registry interim report, reviewed by the MHRA (2020)<\/td>\n<td>78 pregnancies followed; of 61 live births, 9 had a major birth defect (about 14.75%), including 3 heart defects. Heart defects were about 4.92%, against about 1% in the general population.<\/td>\n<\/tr>\n<tr>\n<td>Registry paper in <em>JAMA Internal Medicine<\/em> (2021)<\/td>\n<td>Of 102 live births followed from early pregnancy, 13 (13%) had a major birth defect. This is above the general population rate of about 3%.<\/td>\n<\/tr>\n<tr>\n<td>Animal studies (SmPC section 5.3)<\/td>\n<td>Showed reproductive toxicity in rats and rabbits, including pregnancy loss and skeletal changes.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>The evidence has limits. The <a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC7573789\/\">registry paper by Kaplan and colleagues<\/a> was small, people joined voluntarily, and there was no comparison group of unexposed pregnancies. Its authors worked for the manufacturer, and they said the data could not prove modafinil was the cause.<\/p>\n<p>The UK Teratology Information Service&#8217;s <a href=\"https:\/\/www.medicinesinpregnancy.org\/leaflets-a-z\/modafinil\/\">bumps leaflet on modafinil<\/a> notes that not all studies agree. Until more is known, it says modafinil is not recommended in pregnancy.<\/p>\n<h2 id=\"contraception\">How modafinil affects contraception<\/h2>\n<p>Modafinil speeds up a set of liver enzymes (called CYP3A4\/5) that break down the hormones in many contraceptives. With less hormone in your body, the contraceptive may not stop you getting pregnant.<\/p>\n<p>The SmPC says the effectiveness of steroidal (hormonal) contraceptives may be reduced. It recommends other or extra methods during treatment, and for two months after stopping modafinil. The <a href=\"https:\/\/www.medicines.org.uk\/emc\/files\/pil.4319.pdf\">patient information leaflet<\/a> names the pill, implants, intrauterine devices and patches among the hormonal contraceptives affected.<\/p>\n<p>This matters twice over. Modafinil can make your contraception less reliable at the same time as it carries a possible risk to a developing baby.<\/p>\n<h2 id=\"which-contraception\">Which contraception works with modafinil?<\/h2>\n<p>The MHRA Drug Safety Update summarises guidance from the Faculty of Sexual and Reproductive Healthcare (FSRH) for medicines like modafinil that speed up these liver enzymes. Your prescriber or a sexual health service can help you choose.<\/p>\n<table>\n<thead>\n<tr>\n<th>Method<\/th>\n<th>What the MHRA guidance says<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Combined pill, patch or vaginal ring<\/td>\n<td>Avoid<\/td>\n<\/tr>\n<tr>\n<td>Progestogen-only pill (mini pill)<\/td>\n<td>Avoid<\/td>\n<\/tr>\n<tr>\n<td>Contraceptive implant<\/td>\n<td>Avoid<\/td>\n<\/tr>\n<tr>\n<td>Copper coil (IUD)<\/td>\n<td>Suitable long-term method<\/td>\n<\/tr>\n<tr>\n<td>Hormonal coil (levonorgestrel IUS)<\/td>\n<td>Suitable long-term method<\/td>\n<\/tr>\n<tr>\n<td>Progestogen-only injection<\/td>\n<td>Suitable long-term method<\/td>\n<\/tr>\n<tr>\n<td>Condoms with your usual method<\/td>\n<td>May be advised if modafinil is only used for a short time (2 months)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>The <a href=\"https:\/\/www.nhs.uk\/contraception\/methods-of-contraception\/iud-coil\/who-can-get-it\/\">NHS page on the copper coil<\/a> confirms an IUD is not affected by other medicines. The patient leaflet&#8217;s list of affected contraceptives mentions intrauterine devices, so check with your prescriber which type of coil suits you.<\/p>\n<h3 id=\"emergency-contraception\">Emergency contraception while taking modafinil<\/h3>\n<p>If you have had unprotected sex, tell the pharmacist or doctor that you take modafinil. The MHRA guidance says a copper IUD is the preferred option. If a copper IUD is not suitable, a double dose of the levonorgestrel emergency pill is advised, given by a pharmacist or doctor who knows about your modafinil.<\/p>\n<p>The guidance recommends avoiding ulipristal acetate emergency contraception while you take modafinil. Do not change the dose of any emergency pill yourself.<\/p>\n<h2 id=\"two-month-rule\">The two-month rule after stopping<\/h2>\n<p>The effect of modafinil on your liver enzymes does not stop on the day you take your last tablet. That is why the SmPC, the patient leaflet and the MHRA all say to keep using effective contraception for two months after stopping modafinil.<\/p>\n<p>The MHRA quoted Dr Sarah Branch saying that women should &#8220;continue to use their contraceptive for 2 months after stopping modafinil&#8221;. Do not switch back to a pill, patch, ring or implant alone until that time has passed and you have checked with your prescriber.<\/p>\n<h2 id=\"planning\">Planning a pregnancy<\/h2>\n<p>If you would like to get pregnant, speak to your specialist before you stop contraception. The MHRA asks prescribers to discuss pregnancy plans early and look at other narcolepsy treatment options.<\/p>\n<p>Narcolepsy can also be managed with regular sleep routines and planned daytime naps, as the <a href=\"https:\/\/www.nhs.uk\/conditions\/narcolepsy\/treatment\/\">NHS narcolepsy treatment guide<\/a> explains. Our <a href=\"https:\/\/yourmedsuk.com\/insights\/narcolepsy\/\">guide to narcolepsy and excessive sleepiness<\/a> covers this in more detail. Never stop or change any prescribed medicine without advice.<\/p>\n<h2 id=\"pregnant-on-modafinil\">If you become pregnant while taking modafinil<\/h2>\n<p>Contact your prescriber, GP or midwife as soon as you can. Do not stop or change any medicine on your own before you have spoken to them. They can weigh up your treatment and arrange the right care.<\/p>\n<p>Many babies exposed to modafinil are born without a birth defect. The bumps leaflet says you will be offered a detailed scan at around 20 weeks, possibly slightly earlier if you took modafinil in early pregnancy. A more detailed scan of the baby&#8217;s heart may also be offered.<\/p>\n<p>Doctors and patients can report suspected side effects in a mother or baby linked to medicines in pregnancy through the Yellow Card scheme, as the MHRA asks.<\/p>\n<h2 id=\"breastfeeding-fertility\">Breastfeeding, fertility and fathers<\/h2>\n<h3>Breastfeeding<\/h3>\n<p>The UK SmPC and patient leaflet say modafinil should not be used during breastfeeding. Animal studies found modafinil in milk.<\/p>\n<p>Human data are very limited. The US <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK513058\/\">LactMed database<\/a> reports very low levels of modafinil in the milk of two nursing mothers. Talk to your specialist about feeding and treatment options before your baby is born.<\/p>\n<h3>Fertility<\/h3>\n<p>The SmPC says there are no human fertility data. In female rats, modafinil slightly increased the time to mate.<\/p>\n<h3>If the father takes modafinil<\/h3>\n<p>The bumps leaflet says no increased risk to the baby is expected if the father takes modafinil.<\/p>\n<h2 id=\"not-prescribed\">If you take modafinil that was not prescribed for you<\/h2>\n<p>Modafinil is licensed in the UK only for sleepiness caused by narcolepsy. Some people take it to try to boost focus, but it is not licensed for this. The same pregnancy risk and contraception interaction apply to anyone who takes it.<\/p>\n<p>Our guide to <a href=\"https:\/\/yourmedsuk.com\/insights\/is-modafinil-legal-uk\/\">modafinil and UK law<\/a> explains its legal status. The <a href=\"https:\/\/yourmedsuk.com\/insights\/modafinil-side-effects\/\">modafinil side effects guide<\/a> covers its other risks, including skin, mental health and heart effects.<\/p>\n<div class=\"ym-help\">\n<h2>When to get help<\/h2>\n<p><strong>Call 999 or go to A&amp;E if you or someone else has:<\/strong><\/p>\n<ul>\n<li>swelling of the lips, face, tongue or throat, or difficulty breathing<\/li>\n<li>a widespread rash with blistering or peeling skin<\/li>\n<\/ul>\n<p><strong>Call NHS 111 or contact your GP, specialist or midwife soon if you:<\/strong><\/p>\n<ul>\n<li>find out you are pregnant while taking modafinil, or within two months of stopping<\/li>\n<li>have had unprotected sex or a contraception problem while taking modafinil<\/li>\n<li>are planning a pregnancy and want to talk about treatment options<\/li>\n<\/ul>\n<p>You can report any suspected side effect to the MHRA through the <a href=\"https:\/\/yellowcard.mhra.gov.uk\/\">Yellow Card scheme<\/a>. Anyone can report.<\/p>\n<\/div>\n<div class=\"ym-faq\">\n<h2>Frequently asked questions<\/h2>\n<h3>Does modafinil affect contraception?<\/h3>\n<p>Yes. Modafinil can make hormonal contraception less effective, including the pill, patch, ring and implant. MHRA guidance lists the copper coil, the hormonal coil and the progestogen-only injection as suitable long-term methods.<\/p>\n<h3>Can I take modafinil while pregnant?<\/h3>\n<p>No. UK guidance says modafinil should not be used during pregnancy because it may increase the chance of birth defects. If you are pregnant, contact your prescriber promptly and do not stop any medicine without advice.<\/p>\n<h3>How long after stopping modafinil can I get pregnant?<\/h3>\n<p>The MHRA says to keep using effective contraception for two months after stopping modafinil. Plan any pregnancy with your specialist first, so they can discuss other narcolepsy treatments.<\/p>\n<h3>Does the contraceptive implant work with modafinil?<\/h3>\n<p>The implant is one of the methods MHRA guidance says to avoid while taking modafinil. Ask your prescriber or a sexual health clinic about switching to a method that is not affected.<\/p>\n<h3>Can I breastfeed while taking modafinil?<\/h3>\n<p>The UK product information says modafinil should not be used during breastfeeding. Speak to your specialist about your options before your baby arrives.<\/p>\n<\/div>\n<div class=\"ym-related\">\n<h2>Related guides<\/h2>\n<ul>\n<li><a href=\"https:\/\/yourmedsuk.com\/insights\/modafinil\/\">Modafinil: what it is, how it works and who it&#8217;s for<\/a><\/li>\n<li><a href=\"https:\/\/yourmedsuk.com\/insights\/modafinil-side-effects\/\">Modafinil side effects: common, serious and when to get help<\/a><\/li>\n<li><a href=\"https:\/\/yourmedsuk.com\/insights\/modafinil-heart-blood-pressure\/\">Is modafinil safe? Your heart, blood pressure and long-term use<\/a><\/li>\n<li><a href=\"https:\/\/yourmedsuk.com\/insights\/is-modafinil-legal-uk\/\">Is modafinil legal in the UK?<\/a><\/li>\n<li><a href=\"https:\/\/yourmedsuk.com\/insights\/check-uk-online-pharmacy\/\">How to check a UK online pharmacy<\/a><\/li>\n<li><a href=\"https:\/\/yourmedsuk.com\/insights\/narcolepsy\/\">Narcolepsy and excessive sleepiness<\/a><\/li>\n<li><a href=\"https:\/\/yourmedsuk.com\/insights\/modafinil-interactions\/\">Modafinil and alcohol: caffeine, contraception and other interactions<\/a><\/li>\n<\/ul>\n<\/div>\n<div class=\"ym-refs\">\n<h2>References<\/h2>\n<ol>\n<li><a href=\"https:\/\/www.gov.uk\/drug-safety-update\/modafinil-provigil-increased-risk-of-congenital-malformations-if-used-during-pregnancy\">Modafinil (Provigil): increased risk of congenital malformations if used during pregnancy<\/a>, MHRA Drug Safety Update, 16 November 2020, accessed October 2026<\/li>\n<li><a href=\"https:\/\/www.gov.uk\/government\/news\/sleep-disorder-drug-modafinil-linked-to-increased-risk-of-birth-defects-and-also-to-reduced-effectiveness-of-contraception\">Sleep disorder drug modafinil linked to increased risk of birth defects and also to reduced effectiveness of contraception<\/a>, MHRA press release, GOV.UK, 16 November 2020, accessed October 2026<\/li>\n<li><a href=\"https:\/\/www.medicines.org.uk\/emc\/product\/4319\/smpc\">Modafinil 100 mg tablets \u2013 Summary of Product Characteristics<\/a>, electronic medicines compendium (emc), revised February 2024, accessed October 2026<\/li>\n<li><a href=\"https:\/\/www.medicines.org.uk\/emc\/files\/pil.4319.pdf\">Modafinil 100 mg and 200 mg tablets \u2013 Patient Information Leaflet<\/a>, electronic medicines compendium (emc), revised August 2024, accessed October 2026<\/li>\n<li><a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC7573789\/\">Kaplan S, Braverman DL, Frishman I, Bartov N. Pregnancy and fetal outcomes following exposure to modafinil and armodafinil during pregnancy<\/a>, JAMA Internal Medicine 2021;181(2):275\u2013277, accessed October 2026<\/li>\n<li><a href=\"https:\/\/www.medicinesinpregnancy.org\/leaflets-a-z\/modafinil\/\">Modafinil (bumps leaflet)<\/a>, UK Teratology Information Service, May 2025, accessed October 2026<\/li>\n<li><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK513058\/\">Modafinil \u2013 Drugs and Lactation Database (LactMed)<\/a>, National Institute of Child Health and Human Development, revised April 2025, accessed October 2026<\/li>\n<li><a href=\"https:\/\/www.nhs.uk\/contraception\/methods-of-contraception\/iud-coil\/who-can-get-it\/\">Who can get an IUD (intrauterine device) or copper coil<\/a>, NHS, accessed October 2026<\/li>\n<li><a href=\"https:\/\/www.nhs.uk\/conditions\/narcolepsy\/treatment\/\">Narcolepsy: treatment<\/a>, NHS, accessed October 2026<\/li>\n<li><a href=\"https:\/\/yellowcard.mhra.gov.uk\/\">Yellow Card scheme<\/a>, MHRA, accessed October 2026<\/li>\n<\/ol>\n<\/div>\n<p class=\"ym-disclaimer\">This article is for information only and does not replace advice from your doctor or pharmacist. Read our <a href=\"https:\/\/yourmedsuk.com\/insights\/medical-disclaimer\/\">medical disclaimer<\/a>.<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>What UK guidance says about modafinil and pregnancy: the possible birth defect risk and the evidence behind it, why the pill and implant may not work, which contraception does, the two-month rule, and what to do if you are planning a baby or are pregnant.<\/p>\n","protected":false},"author":1,"featured_media":199,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[19],"tags":[],"class_list":["post-200","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-modafinil"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Modafinil and Pregnancy: Risks &amp; the Pill | Your Meds UK<\/title>\n<meta name=\"description\" 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