Doxylamine

Mechanism-of-action classes: Histamine H1 Receptor Antagonists; Histamine Receptor Antagonists.

• Use helps to reduce difficulty in falling asleep

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

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.

• Sep 18, 1996ANDAANDA040167Perrigo
• Aug 27, 2004ANDAANDA040564Lnk
• Apr 8, 2013NDANDA021876Duchesnay
• Aug 19, 2016ANDAANDA205811Actavis Labs Fl Inc
• Nov 7, 2016NDANDA209661Duchesnay
• Dec 6, 2017ANDAANDA208518Ph Health
• Aug 4, 2023ANDAANDA217000Bionpharma

1. 1Drug Ineffective1,15415%
2. 2Somnolence5677.4%
3. 3Fatigue4125.4%
4. 4Nausea3534.6%
5. 5Dizziness2863.8%
6. 6Insomnia2813.7%
7. 7Headache2753.6%
8. 8Toxicity To Various Agents2573.4%
9. 9Vomiting2543.3%
10. 10Diarrhoea2523.3%
11. 11Maternal Exposure During Pregnancy2463.2%
12. 12Dyspnoea2433.2%
13. 13Feeling Abnormal2323.0%
14. 14Underdose2313.0%
15. 15Cough2152.8%

Recent PubMed references pinned to Doxylamine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Structure-reactivity relationships in UV/chlorine degradation, NDMA formation, and cytotoxicity of chlorpheniramine and doxylamine.
  Journal of hazardous materials · 2026 · Peng SW, Lin PJ, Lin YH, et al.
  PMID 41702163DOI 10.1016/j.jhazmat.2026.141453
• Two sustainable chromatographic approaches for estimation of new combination of phenylephrine hydrochloride and doxylamine succinate in presence of doxylamine oxidative degradation product.
  Scientific reports · 2025 · Abd El-Hadi HR
  PMID 41131091DOI 10.1038/s41598-025-22295-6
• How do you Zzz during pregnancy? A brief review of Z-drug use and management of insomnia during pregnancy.
  Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025 · Tu X, Junna MR, Kolla BP, et al.
  PMID 40259749DOI 10.5664/jcsm.11740
• Changes in doxylamine-pyridoxine dispensation in Ontario following media attention: Time-series analysis.
  Canadian family physician Medecin de famille canadien · 2025 · Chaudhry S, Yazdani S, Chu C, et al.
  PMID 39843186DOI 10.46747/cfp.710143
• Assessing disintegration effectiveness: A thorough evaluation using the SeDeM-ODT expert system for doxylamine succinate orodispersible formulation.
  PloS one · 2024 · Ahmad SA, Hasan SMF, Bafail D, et al.
  PMID 39288134DOI 10.1371/journal.pone.0310334
• Reply Letter - to Urso et al "Comment on: Comparative dissolution profiles of two anti-emetic delayed release dosage forms of doxylamine and pyridoxine: Xonvea® tablets vs. Cariban® capsules".
  European review for medical and pharmacological sciences · 2022 · Alcocer C, Rom E, Regidor PA, et al.
  PMID 36524482DOI 10.26355/eurrev_202212_30533
• Comment on: Comparative dissolution profiles of two anti-emetic delayed-release dosage forms of doxylamine and pyridoxine: Xonvea® tablets vs. Cariban® capsules.
  European review for medical and pharmacological sciences · 2022 · Urso K, Saz-Leal P, Zamorano Dominguez L, et al.
  PMID 36459003DOI 10.26355/eurrev_202211_30351
• The risk of questioning the safety of drugs considered safe in pregnancy at the era of big data: the everlasting case of doxylamine.
  Journal of clinical epidemiology · 2022 · Panchaud A, Cleary B, Weber-Schoendorfer C, et al.
  PMID 36223814DOI 10.1016/j.jclinepi.2022.10.007

The 10 most recently updated of 18 ClinicalTrials.gov registrations naming Doxylamine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• The Efficacy and Safety of Bonjesta® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents
  Suspended · Phase 3 · Interventional · 274 enrolled · Duchesnay Inc.
  NCT05289557updated 2026-04-03
• E7 TCR T Cells for Human Papillomavirus-Associated Cancers
  Completed · Phase 1 · Phase 2 · Interventional · 224 enrolled · National Cancer Institute (NCI)
  NCT02858310updated 2026-03-09
• A Clinical Evidence Study Evaluating Quality of Life Parameters Following Treatment With Robitussin
  Completed · Phase 4 · Interventional · 244 enrolled · HALEON
  NCT06716645updated 2026-02-20
• Date Fruit Benefits to Treat Morning Sickness in First Trimester of Pregnancy
  Active not recruiting · Interventional · 40 enrolled · Bahria University
  NCT07354529updated 2026-01-21
• Pharmacokinetics and Bioequivalence of Doxylamine+Pyridoxine and Diclectin Under Fed Conditions in Healthy Volunteers
  Completed · Phase 1 · Interventional · 28 enrolled · Valenta Pharm JSC
  NCT06342778updated 2025-07-11
• Tablet Ginger Versus Tablet Doxylamine Succinate in Control of Nausea and Vomiting in Pregnancy
  Not yet recruiting · Interventional · 66 enrolled · Nawaz Sharif Medical College
  NCT06772974updated 2025-01-17
• Therapeutic Implications of Acutaping on Nausea and Vomiting During Pregnancy
  Completed · Interventional · 27 enrolled · Kafrelsheikh University
  NCT06259747updated 2024-02-16
• Pharmacokinetics and Bioequivalence of Doxylamine + Pyridoxine, Film-coated, Enteric-soluble Tablets, and Diclectin, Delayed Release Tablets, in Healthy Volunteers
  Completed · Interventional · 28 enrolled · Valenta Pharm JSC
  NCT05498233updated 2023-07-27
• Effectiveness of Acupuncture and Doxylamine/Pyridoxine for Moderate to Severe Nausea and Vomiting in Pregnancy
  Completed · Phase 3 · Interventional · 352 enrolled · Xiaoke Wu
  NCT04401384updated 2022-04-04
• A Multicenter Trial of the Efficacy and Safety of Diclegis® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents
  Terminated · Phase 4 · Interventional · 131 enrolled · Duchesnay Inc.
  NCT02045901updated 2021-11-23

Frequently asked questions

How does Doxylamine work?

Mechanism-of-action classes: Histamine H1 Receptor Antagonists; Histamine Receptor Antagonists.

What is Doxylamine used for?

According to FDA labeling, Doxylamine carries indications including: Use helps to reduce difficulty in falling asleep. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Doxylamine?

Doxylamine is classified as Aminoalkyl ethers, Antihistamine, Histamine H1 Receptor Antagonists, Histamine Receptor Antagonists, Decreased Histamine Activity.

What are the brand names for Doxylamine?

Doxylamine is marketed under brand names including Aldex AN, Bonjesta, Diclegis, Nocto, Unisom, Wal-Som (doxylamine), Zzzquil Ultra.