Effects of doxylamine: A Synthesis of Findings from 25 Studies

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Original Abstract of the Article

Major research findings

Doxylamine is a first-generation antihistamine that is used to treat nausea and vomiting of pregnancy and insomnia. 18 , 13 , 11 Doxylamine is marketed as a sleep aid, 2 , 1 , 16 , 25 , 6 but for nausea and vomiting of pregnancy, it is generally considered more effective when combined with pyridoxine (vitamin B6). 13 , 10 , 8 Like other antihistamines, doxylamine may cause adverse effects on the nervous system. 17 , 21 , 19 , 9 , 15 Moreover, doxylamine can cause severe adverse effects when combined with other drugs like mephedrone and heroin. 14 It is important to consult a doctor before taking doxylamine, as it can interact with other medications. , 24

Benefits and risks

Benefit summary

Doxylamine may be effective in treating nausea and vomiting of pregnancy and insomnia. 18 , 13 , 11 , 2 , 1 For nausea and vomiting of pregnancy, it is generally considered more effective when combined with pyridoxine (vitamin B6). 13 , 10 , 8

Risk summary

Doxylamine may cause adverse effects on the nervous system. 17 , 21 , 19 , 9 , 15 Moreover, doxylamine can cause severe adverse effects when combined with other drugs like mephedrone and heroin. 14 It is important to consult a doctor before taking doxylamine, as it can interact with other medications. , 24

Comparison of studies

Commonalities

Many studies have shown that doxylamine is effective in treating nausea and vomiting of pregnancy and insomnia. 18 , 13 , 11 , 2 , 1 , 10 , 8

Differences

Some studies have shown that doxylamine may cause adverse effects on the nervous system. 17 , 21 , 19 , 9 , 15 Moreover, doxylamine can cause severe adverse effects when combined with other drugs like mephedrone and heroin. 14

Consistency and inconsistencies of results

Doxylamine has been shown to be effective in treating nausea and vomiting of pregnancy and insomnia, but it can cause adverse effects on the nervous system. 18 , 13 , 11 , 2 , 1 , 17 , 21 , 19 , 9 , 15

Points to consider for real-life application

Doxylamine may be effective in treating nausea and vomiting of pregnancy and insomnia, but it can cause adverse effects on the nervous system. 18 , 13 , 11 , 2 , 1 , 17 , 21 , 19 , 9 , 15 Moreover, doxylamine can cause severe adverse effects when combined with other drugs like mephedrone and heroin. 14 It is important to consult a doctor before taking doxylamine, as it can interact with other medications. , 24

Limitations of current research

There is a lack of research on the adverse effects of doxylamine. 17 , 21 , 19 , 9 , 15 There is also a lack of research on the interactions of doxylamine with other medications. , 24

Future research directions

Further research is needed on the adverse effects of doxylamine. 17 , 21 , 19 , 9 , 15 Research on the interactions of doxylamine with other medications is also needed. , 24

Conclusion

Doxylamine may be effective in treating nausea and vomiting of pregnancy and insomnia, but it can cause adverse effects on the nervous system. 18 , 13 , 11 , 2 , 1 , 17 , 21 , 19 , 9 , 15 Moreover, doxylamine can cause severe adverse effects when combined with other drugs like mephedrone and heroin. 14 It is important to consult a doctor before taking doxylamine, as it can interact with other medications. , 24

Literature analysis of 25 papers
Positive Content
16
Neutral Content
3
Negative Content
6
Article Type
5
2
2
4
25
1.

Food effects on the pharmacokinetics of doxylamine hydrogen succinate 25 mg film-coated tablets: a single-dose, randomized, two-period crossover study in healthy volunteers.

Author: VidelaSebastián, LahjouMounia, GuibordPascal, XuZhengguo, TolràCarles, EncinaGregorio, SicardEric, SansArtur

Insomnia relief

Doxylamine succinate, an antihistamine, is used to treat insomnia. This review discusses the limited pharmacokinetic data available on doxylamine, particularly the lack of information on how food affects its absorption and elimination.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

2.

A Phase I Study of the Pharmacokinetics and Pharmacodynamics of Intranasal Doxylamine in Subjects with Chronic Intermittent Sleep Impairment.

Author: AllisonMark, HaleCecilia

Intranasal doxylamine succinate nasal spray did not improve absorption or bioavailability compared with oral tablets in a group of 24 adults with chronic sleep impairment.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

5.

Interventions for treating nausea and vomiting in pregnancy: a network meta-analysis and trial sequential analysis of randomized clinical trials.

Author: SridharanKannan, SivaramakrishnanGowri

Reduced nausea
Reduced vomiting
Adverse events

Ginger is the only intervention with conclusive evidence for treating nausea and vomiting in pregnancy.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

8.

Acupuncture and Doxylamine-Pyridoxine for Nausea and Vomiting in Pregnancy : A Randomized, Controlled, 2&#8201;<b>&#215;</b>&#8201;2 Factorial Trial.

Author: WuXiao-Ke, GaoJing-Shu, MaHong-Li, WangYu, ZhangBei, LiuZhao-Lan, LiJian, CongJing, QinHui-Chao, YangXin-Ming, WuQi, ChenXiao-Yong, LuZong-Lin, FengYa-Hong, QiXue, WangYan-Xiang, YuLan, CuiYing-Mei, AnChun-Mei, ZhouLi-Li, HuYu-Hong, LiLu, CaoYi-Juan, YanYing, LiuLi, LiuYu-Xiu, LiuZhi-Shun, PainterRebecca C, NgErnest H Y, LiuJian-Ping, MolBen Willem J, WangChi Chiu

Reduced NVP
None reported

Both acupuncture and doxylamine-pyridoxine were efficacious for moderate to severe nausea and vomiting of pregnancy (NVP), but the combination of both treatments might offer a greater benefit.

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

9.

Antihistamines and birth defects: a systematic review of the literature.

Author: GilboaSuzanne M, AilesElizabeth C, RaiRamona P, AndersonJaynia A, HoneinMargaret A

Antihistamine safety
Birth defect risk

This systematic evaluation of the peer-reviewed epidemiologic literature on the association between prenatal exposure to antihistamines and birth defects found that the literature is generally reassuring. However, additional studies are needed to assess the safety of H2-receptor antagonists.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

10.

Studying the antiemetic effect of vitamin B6 for morning sickness: pyridoxine and pyridoxal are prodrugs.

Author: MatokIlan, ClarkShannon, CaritisSteve, MiodovnikMenachem, UmansJason G, HankinsGary, MattisonDonald R, KorenGideon

Antiemetic effect
Pregnancy nausea relief

This substudy of a randomized, placebo-controlled trial found that pyridoxal 5' phosphate (PLP), a form of vitamin B6, may be the active antiemetic form, suggesting a potential correlation between PLP levels and morning sickness symptoms.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

12.

Pharmacokinetic dose proportionality between two strengths (12.5 mg and 25 mg) of doxylamine hydrogen succinate film-coated tablets in fasting state: a single-dose, randomized, two-period crossover study in healthy volunteers.

Author: VidelaSebastián, CebrecosJesús, LahjouMounia, WagnerFrance, GuibordPascal, XuZhengguo, CabotAnna, EncaboMercedes, EncinaGregorio, SicardEric, SansArtur

This study examines the dose proportionality of the pharmacokinetics of doxylamine succinate, an antihistamine used for insomnia. Further research is needed to determine the relationship between dose and pharmacokinetic parameters.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

Multiple-drug toxicity caused by the coadministration of 4-methylmethcathinone (mephedrone) and heroin.

Author: DicksonAmber J, VorceShawn P, LevineBarry, PastMarilyn R

Drug toxicity

This report describes an accidental death caused by the combined use of mephedrone and heroin.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, U.S. Gov't, Non-P.H.S.Research funding provided by US government agencies other than the Public Health Service.

Language : English

15.

Long-term neurodevelopment of children exposed to maternal nausea and vomiting of pregnancy and diclectin.

Author: NulmanIrena, RovetJoanne, BarreraMaru, Knittel-KerenDafna, FeldmanBrian M, KorenGideon

Improved child development
Nausea and vomiting of pregnancy treatment
Safe for fetus
None reported

Nausea and vomiting of pregnancy (NVP) had an enhancing effect on later child outcome, with no adverse effects from diclectin treatment.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

16.

Enantioseparation of Six Antihistamines with Immobilized Cellulose Chiral Stationary Phase by HPLC.

Author: ZhouJie, LuoPei, ChenShanshan, MengLingchang, SunChong, DuQiuzheng, SunFang

A stereoselective HPLC method was developed for chiral separation of enantiomers of six antihistamines.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

17.

The associative factors of delayed-onset rhabdomyolysis in patients with doxylamine overdose.

Author: KimHan Joon, OhSang Hoon, YounChun Song, WeeJung Hee, KimJi Hoon, JeongWon Jung, KimSoo Hyun, JeongSeung Hee, ParkKyu Nam

Rhabdomyolysis

The amount of doxylamine ingested and heart rate were predictors of rhabdomyolysis in patients with doxylamine overdose. In a study of 169 patients, 35 (21%) developed rhabdomyolysis. The amount of doxylamine ingested and heart rate were significantly associated with rhabdomyolysis.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

18.

Histamine-1 receptor antagonism for treatment of insomnia.

Author: Vande GriendJoseph P, AndersonSarah L

Improved sleep

Over-the-counter antihistamines may be effective for short-term insomnia, but low-dose doxepin provides consistent sleep benefits compared to placebo, especially for older adults.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

20.

Comparative effects of pharmacological interventions for the acute and long-term management of insomnia disorder in adults: a systematic review and network meta-analysis.

Author: De CrescenzoFranco, D'AlòGian Loreto, OstinelliEdoardo G, CiabattiniMarco, Di FrancoValeria, WatanabeNorio, KurtulmusAyse, TomlinsonAnneka, MitrovaZuzana, FotiFrancesca, Del GiovaneCinzia, QuestedDigby J, CowenPhil J, BarbuiCorrado, AmatoLaura, EfthimiouOrestis, CiprianiAndrea

Pharmacological treatments for insomnia

This study aimed to compare the effectiveness of different pharmacological treatments for insomnia in adults. While behavioral, cognitive, and pharmacological interventions are effective for insomnia, medications are more widely used due to resource limitations.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

21.

Retrospective review of unintentional pediatric ingestions of doxylamine.

Author: CantrellF Lee, ClarkAlycia K, McKinleyMichael, QoziMariam

Drowsiness
Tachycardia

Unintentional isolated pediatric doxylamine ingestions did not result in significant toxicity in this observational case series of 140 cases. Doses up to 6.2 mg/kg resulted in only transient drowsiness and tachycardia.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

22.

Safety considerations surrounding use of treatment options for nausea and vomiting in pregnancy.

Author: KorenGideon

Medication safety during pregnancy is crucial, particularly for nausea and vomiting of pregnancy (NVP). This review explores the fetal safety of drugs commonly used to treat NVP, emphasizing the need for careful consideration of both treated and untreated NVP risks.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

25.

Spinal sensory and motor blockade by intrathecal doxylamine and triprolidine in rats.

Author: TzengJann-Inn, ChiuChong-Chi, WangJhi-Joung, HungChing-Hsia, ChenYu-Wen

Spinal anesthesia

Doxylamine and triprolidine produced dose-dependent spinal motor and sensory block. Triprolidine was more potent than mepivacaine or doxylamine and had a better nociception-selective action over motor block.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

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