Editing Modafinil (section)

==Contraindications==
Modafinil is contraindicated during pregnancy and 2 months before getting pregnant.<ref name="drug-safety-congenital-2020"/> Women who take modafinil should not become pregnant, and, additionally, should be aware that modafinil reduces effectiveness of hormonal contraceptives, increasing chances of getting pregnant.<ref name="Provigil FDA label" /><ref name="medlineplus.gov-modafinil"/><ref name="sleep-women-2016">{{cite journal|title=Sleep Medications and Women: a Review of Issues to Consider for Optimizing the Care of Women with Sleep Disorders| vauthors = Krystal A, Attarian H |date=December 2016|journal=Current Sleep Medicine Reports|volume=2|issue=4|pages=218–222|doi=10.1007/s40675-016-0060-1}}</ref> Modafinil therapy during pregnancy increases the risk of birth defects,<ref name="pmid33074297"/><ref name="pmid33074296">{{cite journal |vauthors=Ghaffari N, Robertson PA |title=Caution in Prescribing Modafinil and Armodafinil to Individuals Who Could Become Pregnant |journal=JAMA Intern Med |volume=181 |issue=2 |pages=277–278 |date=February 2021 |pmid=33074296 |doi=10.1001/jamainternmed.2020.4206 |s2cid=224780160 }}</ref><ref name="birth-defects-2020">{{cite journal | doi=10.1001/jama.2020.9840 | title=Incidence of Malformations After Early Pregnancy Exposure to Modafinil in Sweden and Norway | date=2020 | journal=JAMA | volume=324 | issue=9 | pages=895–897 | pmid=32870289 | pmc=7489822 | vauthors = Cesta CE, Engeland A, Karlsson P, Kieler H, Reutfors J, Furu K }}</ref><ref name="drug-safety-congenital-2020">{{cite web|url=https://www.gov.uk/drug-safety-update/modafinil-provigil-increased-risk-of-congenital-malformations-if-used-during-pregnancy|title=Modafinil (Provigil): increased risk of congenital malformations if used during pregnancy|date=November 16, 2020|website=GOV.UK|access-date=January 13, 2024|archive-date=January 13, 2024|archive-url=https://web.archive.org/web/20240113182538/https://www.gov.uk/drug-safety-update/modafinil-provigil-increased-risk-of-congenital-malformations-if-used-during-pregnancy|url-status=live}}</ref> such as with [[Torticollis|congenital torticollis]], [[hypospadias]], and [[congenital heart defect]]s.<ref name="pmid33074296" />

Modafinil is contraindicated for individuals with known [[hypersensitivity]] to either modafinil or armodafinil.<ref name="Provigil FDA label" /><ref name="pmid22375280" />

Modafinil is also contraindicated in certain cardiac conditions, including uncontrolled moderate to severe [[hypertension]], [[arrhythmia]], [[Pulmonary heart disease|cor pulmonale]],<ref name="Miller-2020"/><ref name="NHS-UK-2022"/> and in cases with signs of CNS stimulant-induced [[mitral valve prolapse]] or [[left ventricular hypertrophy]].<ref name="safety-2015-04-28">{{cite web | url=https://www.acc.org/latest-in-cardiology/articles/2015/04/28/10/06/the-safety-of-stimulant-medication-use-in-cardiovascular-and-arrhythmia-patients | title=The Safety of Stimulant Medication Use in Cardiovascular and Arrhythmia Patients | access-date=January 29, 2024 | archive-date=January 29, 2024 | archive-url=https://web.archive.org/web/20240129013130/https://www.acc.org/latest-in-cardiology/articles/2015/04/28/10/06/the-safety-of-stimulant-medication-use-in-cardiovascular-and-arrhythmia-patients | url-status=live }}</ref><ref name="europa-packaging">{{cite web | title = Modafinil: Annex III Summary of Product Characteristics, Labelling and Package Leaflet | url = https://www.ema.europa.eu/en/documents/referral/modafinil-annex-iii-summary-product-characteristics-labeling-or-package-leaflet_en.pdf | work = European Medicines Agency | access-date = January 29, 2024 | archive-date = January 29, 2024 | archive-url = https://web.archive.org/web/20240129013129/https://www.ema.europa.eu/en/documents/referral/modafinil-annex-iii-summary-product-characteristics-labeling-or-package-leaflet_en.pdf | url-status = live }}</ref> The package insert in the United States cautions about using modafinil in people with a documented medical history of left ventricular hypertrophy or those diagnosed with mitral valve prolapse who have previously exhibited symptoms associated with the mitral valve prolapse syndrome while undergoing treatment involving central nervous system stimulants.<ref name="pmid16199853">{{cite journal |vauthors=Oskooilar N |title=A case of premature ventricular contractions with modafinil |journal=Am J Psychiatry |volume=162 |issue=10 |pages=1983–4 |date=October 2005 |pmid=16199853 |doi=10.1176/appi.ajp.162.10.1983-a }}</ref> The reasons why modafinil is contraindicated in certain cardiac conditions are because modafinil affects the autonomic nervous system and, in particular, exerts significant effects on autonomic cardiovascular regulation, leading in some people to notable increases in heart rate and blood pressure. These substantial changes in the autonomic system warrant careful consideration when prescribing modafinil to people with pre-existing cardiovascular conditions.<ref name="pmid15753235">{{cite journal |vauthors=Taneja I, Diedrich A, Black BK, Byrne DW, Paranjape SY, Robertson D |title=Modafinil elicits sympathomedullary activation |journal=Hypertension |volume=45 |issue=4 |pages=612–8 |date=April 2005 |pmid=15753235 |doi=10.1161/01.HYP.0000158267.66763.63 |s2cid=9192971 |citeseerx=10.1.1.521.5289 }}</ref> The increase in heart rate and blood pressure can worsen the symptoms of such pre-existing conditions as hypertension, arrhythmia, and cor pulmonale. These changes in the autonomic system induced by modafinil can increase the risk of heart attack, stroke, and heart failure. Modafinil can stimulate the release of norepinephrine and epinephrine, hormones that activate the sympathetic nervous system. This can cause [[vasoconstriction]], which is the narrowing of blood vessels, and increase the heart's workload, which is not desired in people with pre-existing heart conditions. In particular, modafinil can worsen the consequences of mitral valve prolapse or left ventricular hypertrophy, which are structural abnormalities of the heart. These can affect the blood flow and oxygen delivery to the heart and other organs.<ref name="pmid15983798">{{cite journal |vauthors=Hou RH, Freeman C, Langley RW, Szabadi E, Bradshaw CM |title=Does modafinil activate the locus coeruleus in man? Comparison of modafinil and clonidine on arousal and autonomic functions in human volunteers |journal=Psychopharmacology (Berl) |volume=181 |issue=3 |pages=537–49 |date=September 2005 |pmid=15983798 |doi=10.1007/s00213-005-0013-8 |s2cid=10265746 }}</ref>

Modafinil is also contraindicated in people with congenital problems like [[galactose]] intolerance, [[lactase deficiency]], or [[glucose-galactose malabsorption]].<ref name="monograph-2">{{cite web | vauthors = Evans K, Tay S | date = September 2020 | title = Shared Care Guideline – Modafinil for narcolepsy (adults) and excessive daytime sleepiness in Parkinson's disease | work = York and Scarborough Medicines Commissioning Committee | url = https://www.yorkandscarboroughformulary.nhs.uk/docs/SC/Modafinil%20shared%20care%20guideline%20v2.pdf | access-date = January 30, 2024 | archive-date = January 30, 2024 | archive-url = https://web.archive.org/web/20240130034658/https://www.yorkandscarboroughformulary.nhs.uk/docs/SC/Modafinil%20shared%20care%20guideline%20v2.pdf | url-status = live }}</ref><ref name="Miller-2020">{{cite web | vauthors = Miller M | veditors = Morgan J | collaboration = Hull & East Riding Prescribing Committee | title = Prescribing Framework for Modafinil for Daytime Hypersomnolence and excessive daytime sleepiness in Parkinsons | url = https://www.hey.nhs.uk/wp/wp-content/uploads/2021/06/modafanil.pdf | location = Northern Lincolnshire, UK | publisher = National Health Service | access-date = December 2, 2023 | archive-date = December 2, 2023 | archive-url = https://web.archive.org/web/20231202001703/https://www.hey.nhs.uk/wp/wp-content/uploads/2021/06/modafanil.pdf | url-status = live }}</ref><ref name="NHS-UK-2022">{{cite web | title = Modafinil for the treatment of adult patients with excessive sleepiness | url = https://gmmmg.nhs.uk/wp-content/uploads/2022/12/GMMMG-Modafinil-primary-care-info-leaflet_Nov-22-approved.pdf | date = November 10, 2022 | publisher = National Health Service, UK | access-date = December 2, 2023 | archive-date = December 2, 2023 | archive-url = https://web.archive.org/web/20231202001703/https://gmmmg.nhs.uk/wp-content/uploads/2022/12/GMMMG-Modafinil-primary-care-info-leaflet_Nov-22-approved.pdf | url-status = live }}</ref>