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Doxylamine succinate

Class: First Generation Antihistamines
ATC Class: R06AA09
VA Class: AH102
CAS Number: 562-10-7
Brands: Bonjesta (combination), Diclegis (combination), Good Sense Sleep Aid, Unisom
Doxylamine Succinate reference guide for safe and effective use from the American Society of Health-System Pharmacists (AHFS DI).
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Drug Information:
First generation antihistamine; an ethanolamine derivative. Self-medication for short-term management of insomnia, particularly in individuals who have difficulty falling asleep. Safety and efficacy not fully established; however, FDA states that, pending further accumulation of data, doxylamine-containing nighttime sleep aids approved for this use may continue to be marketed in the US. Used in fixed combination with pyridoxine for treatment of nausea and vomiting of pregnancy in women not responding to conservative management. Learn more

Doxylamine succinate is also commercially available in combination with antitussives and decongestants.

AHFS DI Essentials™. © Copyright 2019, Selected Revisions September 24, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

101. Zyber Pharmaceuticals, Inc. Aldex AN (doxylamine succinate) oral suspension prescribing information. Gonzales, LA; undated.

102. Chattem. Unisom SleepTabs (doxylamine succinate) tablets product information. Chattanooga, TN. From Chattem website. Accessed 2017 Oct 24. http://www.unisom.com/our-products/unisom-sleeptabs/

103. Doxylamine. In: Briggs GG, Freeman RK, Towers CV, et al. Drugs in pregnancy and lactation. 11th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2017:454-7.

104. Chattem. Unisom SleepTabs (doxylamine succinate) common questions. Chattanooga, TN. Accessed 2017 Apr 19. http://www.unisom.com/common-questions.html

105. Duchesnay USA, Inc. Diclegis (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets prescribing information. Bryn Mawr PA; 2013 Apr.

106. Duchesnay USA, Inc. Bonjesta (doxylamine succinate and pyridoxine hydrochloride) extended-release tablets prescribing information. Bryn Mawr PA; 2016 Nov.

107. US Food and Drug Administration. Center for Drug Evaluation and Research. Application number 021876Orig1s000: Summary Review. From FDA website. Accessed 2017 Apr. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021876Orig1s000SumR.pdf

108. Koren G, Clark S, Hankins GD et al. Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial. Am J Obstet Gynecol. 2010; 203:571.e1-7. http://www.ncbi.nlm.nih.gov/pubmed/20843504?dopt=AbstractPlus

109. US Department of Health and Human Services. Federal Register. Determination that Bendectin was not withdrawn from sale for reasons of safety or effectiveness. 1999; 64:43190-1.

110. . American College of Obstetricians and Gynecologists. Practice Bulletin No. 153: Nausea and vomiting of pregnancy. Obstet Gynecol. 2015; 126:e12-24. http://www.ncbi.nlm.nih.gov/pubmed/26287788?dopt=AbstractPlus

111. McKeigue PM, Lamm SH, Linn S et al. Bendectin and birth defects: I. A meta-analysis of the epidemiologic studies. Teratology. 1994; 50:27-37. http://www.ncbi.nlm.nih.gov/pubmed/7974252?dopt=AbstractPlus

112. Einarson TR, Leeder JS, Koren G. A method for meta-analysis of epidemiological studies. Drug Intell Clin Pharm. 1988; 22:813-24. http://www.ncbi.nlm.nih.gov/pubmed/3229352?dopt=AbstractPlus

113. Persaud N, Chin J, Walker M. Should doxylamine-pyridoxine be used for nausea and vomiting of pregnancy?. J Obstet Gynaecol Can. 2014; 36:343-348. http://www.ncbi.nlm.nih.gov/pubmed/24798673?dopt=AbstractPlus

114. Pimlott N, Kvern B, Woollard R. Motherisk and Canadian Family Physician. Can Fam Physician. 2017; 63:13-14. http://www.ncbi.nlm.nih.gov/pubmed/28115431?dopt=AbstractPlus

115. Kutcher JS, Engle A, Firth J et al. Bendectin and birth defects. II: Ecological analyses. Birth Defects Res A Clin Mol Teratol. 2003; 67:88-97. http://www.ncbi.nlm.nih.gov/pubmed/12769504?dopt=AbstractPlus

116. Koren G, Clark S, Hankins GD et al. Maternal safety of the delayed-release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial. BMC Pregnancy Childbirth. 2015; 15:59. http://www.ncbi.nlm.nih.gov/pubmed/25884778?dopt=AbstractPlus

117. Seto A, Einarson T, Koren G. Pregnancy outcome following first trimester exposure to antihistamines: meta-analysis. Am J Perinatol. 1997; 14:119-24. http://www.ncbi.nlm.nih.gov/pubmed/9259911?dopt=AbstractPlus

118. Chin JW, Gregor S, Persaud N. Re-analysis of safety data supporting doxylamine use for nausea and vomiting of pregnancy. Am J Perinatol. 2014; 31:701-10. http://www.ncbi.nlm.nih.gov/pubmed/24323370?dopt=AbstractPlus

119. Matthews A, Haas DM, O'Mathúna DP et al. Interventions for nausea and vomiting in early pregnancy. Cochrane Database Syst Rev. 2015; :CD007575. http://www.ncbi.nlm.nih.gov/pubmed/26348534?dopt=AbstractPlus

500. Food and Drug Administration. Drugs for human use; unapproved and misbranded oral drugs labeled for prescription use and offered for relief of symptoms of cold, cough, or allergy, enforcement action dates. Notice. [Docket No. FDA-2011-N-0100] Fed Regist. 2011; 76:11794-8.

a. AHFS Drug Information 2018. McEvoy GK, ed. Doxylamine Succinate. Bethesda, MD: American Society of Health-System Pharmacists; 2018:. From AHFS Drug Information website. Accessed 2018 Mar 2. http://www.ahfsdruginformation.com

b. AHFS Drug Information 2018. McEvoy GK, ed. Antihistamines General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2018:1-8.

More about doxylamine

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  • Drug class: miscellaneous anxiolytics, sedatives and hypnotics

Consumer resources

  • Doxylamine

Professional resources

Other brands: Sleep Aid, Care One Sleep Aid, Equaline Sleep Aid, Equate Sleep Aid, Nighttime Sleepaid

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Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Doxylamine Succinate

Doxylamine succinate Side Effects

Doxylamine Side Effects

For the Consumer

Applies to doxylamine: oral tablets

Side effects include:

Drowsiness.

For Healthcare Professionals

Applies to doxylamine: compounding powder, oral tablet, oral tablet chewable

General

Most side effects are mild and short-lived; serious side effects are rare.

Musculoskeletal

Frequency not reported: Muscle weakness

Nervous system

Frequency not reported: Sedation, dizziness, impaired coordination, paradoxical excitation, drowsiness, headache, anticholinergic effects (e.g., dry mouth, nose, and/or throat)

Respiratory

Frequency not reported: Thicker nasal discharge

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Doxylamine Succinate