Over-the-counter sleep medications
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Prevalence and Patterns of Over-the-Counter Sleep Medication Use
Over-the-counter (OTC) sleep medications are widely used, with estimates suggesting that up to 18% of the population have tried them, and a significant portion use them for extended periods, sometimes over a year . Among older adults, more than half of those using OTC sleep aids are taking products containing diphenhydramine or doxylamine, which are classified as potentially inappropriate for this age group . Usage patterns are diverse, with some individuals combining OTC, natural products, and prescription sleep aids, though most adults use these agents minimally and maintain stable usage patterns over time .
Common Ingredients in OTC Sleep Aids: Diphenhydramine, Doxylamine, Melatonin, and Herbal Supplements
The most common active ingredients in OTC sleep aids are first-generation antihistamines such as diphenhydramine (Benadryl) and doxylamine (Unisom), as well as melatonin and various herbal supplements like valerian and kava Culpepper2015Chung2002Randall2008. In some regions, herbal mixtures such as suanzaorentang are also prevalent . Melatonin is especially popular as a non-prescription option for sleep improvement Culpepper2015Krisha2019.
Efficacy of OTC Sleep Medications
The evidence supporting the effectiveness of OTC sleep aids is mixed. Melatonin, particularly in prolonged-release formulations and among older adults with diagnosed insomnia, shows the most consistent benefits for sleep onset and quality, with good tolerability Culpepper2015Almond2021. In contrast, immediate-release melatonin, diphenhydramine, and valerian have limited evidence for significant sleep improvement Culpepper2015Randall2008Almond2021. Studies on herbal supplements like valerian and kava are inadequate to support their clinical use Chung2002Randall2008.
Safety Concerns and Side Effects
Safety is a major concern with OTC sleep medications, especially for older adults. Diphenhydramine and doxylamine are associated with side effects such as dizziness, imbalance, and next-day residual effects, which can be more pronounced in the elderly due to slower drug metabolism Abraham2017Krisha2019Alhwimani2021. The 2015 Beers Criteria recommend that individuals aged 65 and older avoid these medications due to their risk profile . Melatonin is generally well-tolerated, but its long-term safety, especially at higher doses, is not fully understood, and there are concerns about potential effects on fertility based on animal studies . Herbal supplements lack robust safety data Chung2002Randall2008.
Risks of Misuse and Inappropriate Use
OTC sleep aids are often used without medical supervision, leading to risks of misuse such as long-term use, incorrect dosing, and combining with other medications, which can increase the risk of adverse effects Sexton-Radek2018Krisha2019. Many users, particularly older adults, are unaware of the safety risks associated with these medications . There is also evidence that frequent use of OTC sleep medications may increase the risk of serious health outcomes, such as stroke, in middle-aged and older adults .
Conclusion
OTC sleep medications are commonly used for insomnia and disturbed sleep, but their efficacy is limited for many products, and safety concerns—especially for older adults—are significant. Melatonin shows the most promise among OTC options, while antihistamines like diphenhydramine and doxylamine should be used with caution, particularly in older populations. Users should be aware of potential side effects and consult healthcare providers to ensure safe and appropriate use. More rigorous research is needed to clarify the long-term safety and effectiveness of these widely used products Culpepper2015Abraham2017Chung2002+3 MORE.
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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 medications containing diphenhydramine or doxylamine, which are potentially inappropriate for them.
The Use of Over-the-Counter Sleep Aid Containing Diphenhydramine Hydrochloride Among Saudis
Over-the-counter sleep aids containing diphenhydramine hydrochloride are widely prevalent among Saudis, with younger female students being the majority of users.
Over-the-counter and prescription sleep medication and incident stroke: the REasons for Geographic and Racial Differences in Stroke study.
Over-the-counter sleep medication use may independently increase the risk of stroke in middle-aged to older individuals with no history of stroke.
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