Editing Doxylamine (section)

==Medical uses==
Doxylamine is an antihistamine used to treat [[sneezing]], [[runny nose]], [[watery eyes]], [[hives]], [[skin rash]], [[itching]], and other [[common cold|cold]] or [[allergy]] symptoms. It is also used as a short-term treatment for insomnia.<ref>{{Cite web|url=https://medlineplus.gov/druginfo/meds/a682537.html|title = Doxylamine: MedlinePlus Drug Information}}</ref>

===Insomnia===
The first-generation sedating antihistamines [[diphenhydramine]], [[doxepin]], doxylamine, and [[pyrilamine]] are the most widely used medications in the world for preventing and treating insomnia.<ref name="SimonsSimons2011" /> As of 2004, doxylamine and diphenhydramine, which are both over-the-counter medications, were the agents most commonly used to treat short-term insomnia.<ref>{{cite journal | vauthors = Ringdahl EN, Pereira SL, Delzell JE | title = Treatment of primary insomnia | journal = The Journal of the American Board of Family Practice | volume = 17 | issue = 3 | pages = 212–219 | date = 2004 | pmid = 15226287 | doi = 10.3122/jabfm.17.3.212 | doi-access = free }}</ref> As of 2008 and 2017, over-the-counter antihistamines were not recommended by the [[American Academy of Sleep Medicine]] for treatment of chronic insomnia "due to the relative lack of efficacy and safety data".<ref name="pmid18853708">{{cite journal | vauthors = Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M | title = Clinical guideline for the evaluation and management of chronic insomnia in adults | journal = Journal of Clinical Sleep Medicine | volume = 4 | issue = 5 | pages = 487–504 | date = October 2008 | pmid = 18853708 | pmc = 2576317 | doi = 10.5664/jcsm.27286 }}</ref><ref name="pmid27998379">{{cite journal | vauthors = Sateia MJ, Buysse DJ, Krystal AD, Neubauer DN, Heald JL | title = Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline | journal = Journal of Clinical Sleep Medicine | volume = 13 | issue = 2 | pages = 307–349 | date = February 2017 | pmid = 27998379 | pmc = 5263087 | doi = 10.5664/jcsm.6470 }}</ref> Neither version of their guidelines explicitly included or mentioned doxylamine, although diphenhydramine was discussed.<ref name="pmid18853708" /><ref name="pmid27998379" /> A 2015 systematic review of over-the-counter sleep aids including doxylamine found little evidence to inform the use of doxylamine for treatment of insomnia.<ref name="pmid27057416" />

A major [[systematic review]] and [[network meta-analysis]] of medications for the treatment of insomnia published in 2022 found that doxylamine had an [[effect size]] ([[standardized mean difference]] (SMD)) against [[placebo]] for treatment of insomnia at 4{{nbsp}}weeks of 0.47 (95% {{Abbrlink|CI|confidence interval}} 0.06 to 0.89).<ref name="pmid35843245">{{cite journal | vauthors = De Crescenzo F, D'Alò GL, Ostinelli EG, Ciabattini M, Di Franco V, Watanabe N, Kurtulmus A, Tomlinson A, Mitrova Z, Foti F, Del Giovane C, Quested DJ, Cowen PJ, Barbui C, Amato L, Efthimiou O, Cipriani A | display-authors = 6 | title = Comparative effects of pharmacological interventions for the acute and long-term management of insomnia disorder in adults: a systematic review and network meta-analysis | journal = Lancet | volume = 400 | issue = 10347 | pages = 170–184 | date = July 2022 | pmid = 35843245 | doi = 10.1016/S0140-6736(22)00878-9 | s2cid = 250536370 | doi-access = free | hdl = 11380/1288245 | hdl-access = free }}</ref> The [[quality of evidence|certainty of evidence]] was rated as moderate.<ref name="pmid35843245" /> No data were available for doxylamine in terms of longer-term treatment (3{{nbsp}}months).<ref name="pmid35843245" /> For comparison, the other sedating medicines assessed, [[doxepin]] and [[trimipramine]] (both of which are tricyclic antidepressants)  had effect sizes (SMD) at 4{{nbsp}}weeks of 0.30 (95% CI –0.05 to 0.64) (very low certainty evidence) and 0.55 (95% CI –0.11 to 1.21) (very low certainty evidence), respectively.<ref name="pmid35843245" />

Doses of doxylamine that have been used for sleep range from 5 to 50{{nbsp}}mg, with 25{{nbsp}}mg being the typical dose.<ref name="Perry2007">{{Cite book|url=https://books.google.com/books?id=h7lva61Muq4C&pg=PA377|title = Psychotropic Drug Handbook|isbn = 9780781762731| vauthors = Perry PJ |year = 2007|publisher=Lippincott Williams & Wilkins}}</ref><ref name="pmid30879783">{{cite journal | vauthors = Dupuis G, Vaugeois JM | title = [The interesting anti-H1 effects in maintenance insomnia: A reflection on the comparative advantages of doxylamine and doxepin] | language = French | journal = L'Encephale | volume = 46 | issue = 1 | pages = 80–82 | date = February 2020 | pmid = 30879783 | doi = 10.1016/j.encep.2019.01.006 | trans-title = The interesting anti-H1 effects in maintenance insomnia: A reflection on the comparative advantages of doxylamine and doxepin | s2cid = 151085176 | doi-access = free }}</ref><ref name="pmid26609210">{{cite journal | vauthors = Lie JD, Tu KN, Shen DD, Wong BM | title = Pharmacological Treatment of Insomnia | journal = P & T | volume = 40 | issue = 11 | pages = 759–771 | date = November 2015 | pmid = 26609210 | pmc = 4634348 }}</ref><ref name="pmid31913218" />

===Morning sickness===
Doxylamine is used in the [[combination drug]] [[pyridoxine/doxylamine]] to treat [[morning sickness]] (nausea and vomiting of pregnancy).<ref name="pmid24748822" /><ref name="pmid24574047" /><ref name=pmid24421551>{{cite journal | vauthors = Cada DJ, Demaris K, Levien TL, Baker DE | title = Doxylamine succinate/pyridoxine hydrochloride | journal = Hospital Pharmacy | volume = 48 | issue = 9 | pages = 762–766 | date = October 2013 | pmid = 24421551 | pmc = 3857125 | doi = 10.1310/hpj4809-762 }}</ref> It is the only medication approved by the United States [[Food and Drug Administration]] for the treatment of morning sickness.<ref name="pmid24748822" /><ref name="pmid24574047" />

===Available forms===
{{See also|Pyridoxine/doxylamine}}

Doxylamine is used medically as doxylamine succinate, the [[succinate]] [[salt (chemistry)|salt]] of doxylamine, and is available both alone (brand names Decapryn, Doxy-Sleep-Aid, Unisom) and in combination with [[pyridoxine]] (a form of [[vitamin B6|vitamin B<sub>6</sub>]]) (brand names Bendectin, Bonjesta, Diclegis).<ref name="Drugs@FDA">{{cite web | title=Drugs@FDA: FDA-Approved Drugs | website=accessdata.fda.gov | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm | archive-url=https://web.archive.org/web/20161104020633/http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm | url-status=dead | archive-date=4 November 2016 | access-date=23 August 2022}}</ref> Doxylamine is available alone as [[immediate-release]] [[oral administration|oral]] [[tablet (pharmacy)|tablet]]s containing 25{{nbsp}}mg doxylamine succinate.<ref name="Drugs@FDA" /> Oral tablets containing 12.5{{nbsp}}mg doxylamine succinate as well as oral [[capsule (pharmacy)|capsule]]s containing 25{{nbsp}}mg doxylamine succinate were also previously available but were discontinued.<ref name="Drugs@FDA" /> The [[pyridoxine/doxylamine|combination of doxylamine and pyridoxine]] is available in the form of [[extended-release|extended-]] and [[delayed-release (pharmacy)|delayed-release]] oral tablets containing 10 to 20{{nbsp}}mg doxylamine succinate and 10 to 20{{nbsp}}mg pyridoxine hydrochloride.<ref name="Drugs@FDA" /> Doxylamine alone is available [[over-the-counter]], whereas doxylamine in combination with pyridoxine is a [[prescription-only medication]].<ref name="Drugs@FDA" /> Doxylamine is also available in over-the-counter nighttime [[cold medicine]] products such as NyQuil Cold & Flu (contains [[acetaminophen]], doxylamine succinate 6.25 to 12.5{{nbsp}}mg, and [[dextromethorphan hydrobromide]]), where it serves as the sedating component.<ref name="DailyMed-NyQuil">{{cite web | url=https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=620bc3dc-099b-40bd-be22-e4c3f9c8e09d | work = DailyMed | title = VICKS NYQUIL COLD AND FLU - acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled | publisher = U.S. National Library of Medicine }}</ref><ref name="GoodRx-NyQuil">{{cite web | url=https://www.goodrx.com/nyquil/what-is | title=Nyquil Cold and Flu: Basics, Side Effects & Reviews }}</ref>