Doxylamine vs diphenhydramine

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Comparative Analysis of Doxylamine vs. Diphenhydramine

Pharmacokinetics in Women on Low-Dose Estrogen Oral Contraceptives

A study investigated the pharmacokinetics of doxylamine and diphenhydramine in women using low-dose estrogen oral contraceptives. The research found no significant differences in the pharmacokinetic variables between the control group and the oral contraceptive group for both antihistamines. For doxylamine, the peak plasma concentration, time to peak, elimination half-life, and total clearance were similar between the two groups. Similarly, diphenhydramine showed no significant differences in these pharmacokinetic parameters between the groups .

Determination in Pharmaceutical Products

High-performance thin-layer chromatography (HPTLC) was used to determine the presence of diphenhydramine hydrochloride and doxylamine succinate in pharmaceutical sleep aids. The method proved to be precise and accurate, with diphenhydramine hydrochloride content ranging from 97.9% to 113% of the label values, and doxylamine succinate showing similar precision and accuracy .

Efficacy and Safety for Sleep Disorders

A systematic review evaluated the efficacy and safety of over-the-counter (OTC) sleep aids, including diphenhydramine and doxylamine. The review concluded that diphenhydramine and valerian showed limited beneficial effects for sleep disorders. In contrast, melatonin, particularly prolonged-release formulations, demonstrated more consistent benefits in improving sleep onset and quality .

Use Among Older Adults

A study focused on the use of OTC sleep aids containing diphenhydramine and doxylamine among older adults. It found that a significant proportion of older adults used these medications despite recommendations against their use due to potential safety risks. The study highlighted a lack of awareness about these risks among users, suggesting a need for better education and consultation with healthcare providers 46.

Toxicity and Safety Concerns

Doxylamine has been associated with cases of poisoning, although such incidents are rare. High concentrations of doxylamine in the blood and organs have been reported in lethal intoxications, often involving combined substances . In pediatric cases, unintentional ingestions of doxylamine generally resulted in mild and self-limiting symptoms, with no significant toxicity observed .

Conclusion

Both doxylamine and diphenhydramine are commonly used OTC sleep aids with similar pharmacokinetic profiles in women on low-dose estrogen oral contraceptives. However, their efficacy in treating sleep disorders is limited, and they pose potential safety risks, particularly for older adults. Awareness and education about these risks are crucial for safer use of these medications.

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Most relevant research papers on this topic

Doxylamine and Diphenhydramine Pharmacokinetics in Women on Low‐Dose Estrogen Oral Contraceptives

Low-dose estrogen-containing oral contraceptives do not significantly influence the pharmacokinetics of antihistamines doxylamine and diphenhydramine in women.

RCT

1989·

24citations

·B. Luna et al.

DETERMINATION OF THE SLEEP AID INGREDIENTS DIPHENHYDRAMINE HYDROCHLORIDE AND DOXYLAMINE SUCCINATE IN PHARMACEUTICAL PRODUCTS BY QUANTITATIVE HPTLC

The developed HPTLC method effectively determines diphenhydramine hydrochloride and doxylamine succinate in pharmaceutical sleep aid products, with high precision and accuracy.

1999·

11citations

·D. Digregorio et al.

Over-the-Counter Agents for the Treatment of Occasional Disturbed Sleep or Transient Insomnia: A Systematic Review of Efficacy and Safety.

Common over-the-counter sleep-aid agents, especially diphenhydramine and valerian, lack robust clinical evidence supporting efficacy and safety for occasional disturbed sleep or transient insomnia.

Systematic Review

2015·

45citations

·L. Culpepper et al.

Over-the-counter medications containing diphenhydramine and doxylamine used by older adults to improve sleep

Most older adults in a limited sample in the United States are taking over-the-counter sleep medications containing diphenhydramine or doxylamine, which are potentially inappropriate for them.

Observational Study

2017·

38citations

·Olufunmilola Abraham et al.

Suicide through doxylamine poisoning.

Doxylamine poisoning, a common sleep-inducing agent, can cause fatalities when combined with other drugs, such as diphenhydramine, in the Federal Republic of Germany.

Case Report

2001·

22citations

·Britta Bockholdt et al.

Over-the-counter medications containing diphenhydramine and doxylamine used by older adults to improve sleep, a Letter

Older adults using over-the-counter medications containing diphenhydramine/doxylamine may not be aware of potential safety risks, highlighting the need for improved health literacy in this population.

2017·

1citation

·Bhuvaneshwari Sudershan et al.

Retrospective review of unintentional pediatric ingestions of doxylamine

Unintentional pediatric doxylamine ingestions did not result in significant toxicity, with doses up to 6.2 mg/kg causing only transient drowsiness and tachycardia.

2015·

6citations

·F. Lee Cantrell et al.

OTC SENIOR STATION: CONSUMER-FACING TECHNOLOGY TO PROMOTE MEDICATION SAFETY

The OTC Senior Station is a user-centered, consumer-facing kiosk in community pharmacies that promotes reduced OTC anticholinergic use by older adults by providing safer alternatives and addressing staffing shortages.

2023·

0citations

·Jordan R Hill et al.

Sleep Health and Appropriate Use of OTC Sleep Aids in Older Adults—Recommendations of a Gerontological Society of America Workgroup

Older adults are more likely to use OTC sleep aids inappropriately, posing risks like daytime sedation and cognitive decline.

Rigorous Journal

2015·

41citations

·S. Albert et al.

First generation antihistaminic drugs used in the treatment of insomnia – superstitions and evidence

First-generation antihistamines have few studies on their efficacy in treating sleep disorders, with doxylamine and diphenhydramine only registered for accidental insomnia treatment, and no studies justifying the use of hydroxyzine for insomnia treatment.

Systematic Review

2020·

3citations

·M. Krzystanek et al.

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