{"id":"doxylamine","rwe":[{"pmid":"41900923","year":"2026","title":"Nausea and Vomiting in Pregnancy: Prevalence, Clinical Characteristics, and Management Findings from a Prospective Italian Multicenter Cohort Study.","finding":"","journal":"Life (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41732465","year":"2026","title":"Torsades de pointes after doxylamine overdose: A case report.","finding":"","journal":"HeartRhythm case reports","studyType":"Clinical Study"},{"pmid":"41702163","year":"2026","title":"Structure-reactivity relationships in UV/chlorine degradation, NDMA formation, and cytotoxicity of chlorpheniramine and doxylamine.","finding":"","journal":"Journal of hazardous materials","studyType":"Clinical Study"},{"pmid":"41552103","year":"2025","title":"Resolution of Fetal Arrhythmia Following Maternal Discontinuation of Doxylamine (Unisom): A Case Report and Review.","finding":"","journal":"Cureus","studyType":"Clinical Study"},{"pmid":"41484753","year":"2026","title":"Clinical characteristics, management and outcomes of hyperemesis gravidarum: a retrospective study in an Irish maternity hospital.","finding":"","journal":"Irish journal of medical science","studyType":"Clinical Study"}],"_fda":{"id":"67863f1b-c028-41f8-8980-05c9452c215a","set_id":"005b5ad8-d762-46b5-a7a5-e0ff11ba936a","openfda":{"upc":["0041163256354"],"unii":["V9BI9B5YI2"],"route":["ORAL"],"rxcui":["1101446"],"spl_id":["67863f1b-c028-41f8-8980-05c9452c215a"],"brand_name":["Sleep Aid"],"spl_set_id":["005b5ad8-d762-46b5-a7a5-e0ff11ba936a"],"package_ndc":["41163-986-22"],"product_ndc":["41163-986"],"generic_name":["DOXYLAMINE SUCCINATE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["DOXYLAMINE SUCCINATE"],"manufacturer_name":["United Natural Foods, Inc. dba UNFI"],"application_number":["ANDA040564"],"is_original_packager":[true]},"purpose":["Purpose Nighttime sleep-aid"],"version":"9","stop_use":["Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness."],"warnings":["Warnings Do not use in children under 12 years of age with any other product containing doxylamine unless you have time for a full night’s sleep Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or any other sleep-aid tranquilizers any other antihistamines any other drugs When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery take only at bedtime Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"questions":["Questions or comments? Call 1-855-423-2630 Mon-Fri 8 am to 6 pm CST"],"ask_doctor":["Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland"],"do_not_use":["Do not use in children under 12 years of age with any other product containing doxylamine unless you have time for a full night’s sleep"],"when_using":["When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery take only at bedtime"],"effective_time":"20260406","active_ingredient":["Active ingredient (in each tablet) Doxylamine succinate 25 mg"],"inactive_ingredient":["Inactive ingredients dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate"],"storage_and_handling":["Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at controlled room temperature 20°-25°C (68°-77°F) see end flap for expiration date and lot number"],"indications_and_usage":["Use helps to reduce difficulty in falling asleep"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or any other sleep-aid tranquilizers any other antihistamines any other drugs"],"dosage_and_administration":["Directions adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years of age: do not use"],"spl_product_data_elements":["Sleep Aid Doxylamine Succinate DOXYLAMINE SUCCINATE DOXYLAMINE DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 ALUMINUM LAKE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A POTATO 44;386"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"package_label_principal_display_panel":["Principal display panel EQUAL INE® compare to Unisom® SleepTabs® active ingredient* NDC 41163-986-22 nighttime sleep aid doxylamine succinate tablets, 25 mg (nighttime sleep aid) • just one tablet per dose 48 mini tablets actual size TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepTabs®. 50844 REV0123D38622 DISTRIBUTED BY UNFI PROVIDENCE, RI 02908 USA 855-423-2630 100% Quality GUARANTEED Equaline 44-386 Equaline 44-386"]},"tags":[{"label":"Antihistamine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Histamine H1 receptor","category":"target"},{"label":"HRH1","category":"gene"},{"label":"R06AA09","category":"atc"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Allergic conjunctivitis","category":"indication"},{"label":"Allergic rhinitis","category":"indication"},{"label":"Common cold","category":"indication"},{"label":"Dermatographic urticaria","category":"indication"},{"label":"Influenza-like symptoms","category":"indication"},{"label":"Itching of skin","category":"indication"},{"label":"Chattem","category":"company"},{"label":"Approved 1940s","category":"decade"},{"label":"Antiemetics","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Gastrointestinal Agents","category":"pharmacology"},{"label":"Histamine Agents","category":"pharmacology"},{"label":"Histamine Antagonists","category":"pharmacology"},{"label":"Histamine H1 Antagonists","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"1150 reports"},{"date":"","signal":"SOMNOLENCE","source":"FDA FAERS","actionTaken":"562 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"402 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"343 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"281 reports"},{"date":"","signal":"INSOMNIA","source":"FDA FAERS","actionTaken":"276 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"272 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"246 reports"},{"date":"","signal":"TOXICITY TO VARIOUS AGENTS","source":"FDA FAERS","actionTaken":"244 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"242 reports"}],"commonSideEffects":[],"contraindications":["Acidosis","Acute hepatitis","Acute pancreatitis","Alcoholism","Angle-closure glaucoma","Arterial thrombosis","Arteriosclerotic vascular disease","Benign prostatic hyperplasia","Bladder outflow obstruction","Bradycardia","Chronic heart failure","Chronic idiopathic constipation","Coronary arteriosclerosis","Diabetes mellitus","Disease of liver","Disorder of coronary artery","Hepatic failure","Hypertensive disorder","Hypertensive urgency","Hyperthyroidism","Hypoxia","Myocardial infarction","Ocular hypertension","Partial atrioventricular block","Peptic ulcer"]},"trials":[],"aliases":[],"company":"Chattem","patents":[],"pricing":[],"_fixedAt":"2026-03-30T13:44:40.411692","_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=DOXYLAMINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:42:01.480973+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:42:07.706196+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:42:00.525430+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DOXYLAMINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:42:08.079050+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:41:58.628509+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:41:58.628533+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:42:09.680350+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1004/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:42:08.872263+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA040564","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:41:58.628536+00:00"}},"allNames":"unisom","offLabel":[],"synonyms":["doxylamine","(+/-)-Doxylamine","doxylamine succinate"],"timeline":[{"date":"1948-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from SANOFI AVENTIS US to Chattem"},{"date":"1948-04-07","type":"positive","source":"DrugCentral","milestone":"FDA approval (Sanofi Aventis Us)"},{"date":"1986-02-05","type":"positive","source":"FDA Orange Book","milestone":"Unisom approved — 25MG"},{"date":"2004-08-27","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 5 manufacturers approved"}],"aiSummary":"Unisom (doxylamine) is a small molecule antihistamine that targets the histamine H1 receptor. Originally developed by Sanofi Aventis US, it is now owned by Chattem and has been FDA-approved since 1948 for various allergic and respiratory conditions. Unisom is available as a generic medication, with multiple manufacturers, and is off-patent. It is used to treat conditions such as allergic conjunctivitis, rhinitis, and common cold symptoms. Key safety considerations include potential drowsiness and interactions with other medications.","approvals":[{"date":"1948-04-07","orphan":false,"company":"SANOFI AVENTIS US","regulator":"FDA"}],"brandName":"Unisom","ecosystem":[{"indication":"Allergic conjunctivitis","otherDrugs":[{"name":"acrivastine","slug":"acrivastine","company":"Auxilium Pharms Inc"},{"name":"alcaftadine","slug":"alcaftadine","company":"Allergan"},{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"antazoline","slug":"antazoline","company":"Novartis"}],"globalPrevalence":null},{"indication":"Allergic rhinitis","otherDrugs":[{"name":"acrivastine","slug":"acrivastine","company":"Auxilium Pharms Inc"},{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"antazoline","slug":"antazoline","company":"Novartis"},{"name":"astemizole","slug":"astemizole","company":""}],"globalPrevalence":null},{"indication":"Common cold","otherDrugs":[{"name":"acetylsalicylic acid","slug":"acetylsalicylic-acid","company":"Endo Pharms"},{"name":"acrivastine","slug":"acrivastine","company":"Auxilium Pharms Inc"},{"name":"ammonium chloride","slug":"ammonium-chloride","company":"B Braun"},{"name":"azatadine","slug":"azatadine","company":""}],"globalPrevalence":null},{"indication":"Dermatographic urticaria","otherDrugs":[{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"antazoline","slug":"antazoline","company":"Novartis"},{"name":"azatadine","slug":"azatadine","company":""},{"name":"brompheniramine","slug":"brompheniramine","company":""}],"globalPrevalence":68000000},{"indication":"Influenza-like symptoms","otherDrugs":[{"name":"acetylsalicylic acid","slug":"acetylsalicylic-acid","company":"Endo Pharms"},{"name":"brompheniramine","slug":"brompheniramine","company":""},{"name":"caffeine","slug":"caffeine","company":"Novartis"},{"name":"chlorphenamine","slug":"chlorphenamine","company":"Bayer Healthcare Llc"}],"globalPrevalence":null},{"indication":"Itching of skin","otherDrugs":[{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"allantoin","slug":"allantoin","company":""},{"name":"ammonium lactate","slug":"ammonium-lactate","company":"Ranbaxy"},{"name":"antazoline","slug":"antazoline","company":"Novartis"}],"globalPrevalence":null},{"indication":"Nasal congestion","otherDrugs":[{"name":"acrivastine","slug":"acrivastine","company":"Auxilium Pharms Inc"},{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"ammonium chloride","slug":"ammonium-chloride","company":"B Braun"},{"name":"antazoline","slug":"antazoline","company":"Novartis"}],"globalPrevalence":null},{"indication":"Nasal discharge","otherDrugs":[{"name":"acrivastine","slug":"acrivastine","company":"Auxilium Pharms Inc"},{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"ammonium chloride","slug":"ammonium-chloride","company":"B Braun"},{"name":"antazoline","slug":"antazoline","company":"Novartis"}],"globalPrevalence":30000000}],"mechanism":{"target":"Histamine H1 receptor","novelty":"Follow-on","targets":[{"gene":"HRH1","source":"DrugCentral","target":"Histamine H1 receptor","protein":"Histamine H1 receptor","isPrimary":true,"activityType":"","activityValue":null}],"moaClass":"Histamine Receptor Antagonists","modality":"Small Molecule","drugClass":"Antihistamine","explanation":"","oneSentence":"","technicalDetail":"Doxylamine is a competitive antagonist of the histamine H1 receptor, with a high affinity for the receptor and a moderate duration of action, which contributes to its efficacy in treating allergic conditions."},"commercial":{"launchDate":"1948","_launchSource":"DrugCentral (FDA 1948-04-07, SANOFI AVENTIS 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