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 by adults of all ages to manage sleep problems, with estimates suggesting that 18% of the general population have used an OTC sleep aid, and over 40% of older adults report frequent use of these products 239. Usage is particularly high among certain groups, such as younger female students and older adults, with many individuals using these medications for extended periods, sometimes over a year or more 269. Most people do not consult healthcare professionals before using OTC sleep aids, which can lead to misuse, including long-term use, incorrect dosing, and combining with other medications 34.
Common Types of OTC Sleep Medications and Their Efficacy
The most common OTC sleep aids include antihistamines (such as diphenhydramine and doxylamine), melatonin, and herbal supplements like valerian 157. Among these, melatonin—especially in prolonged-release formulations—has shown the most consistent benefits for improving sleep onset and quality, particularly in older adults, and is generally well-tolerated 15. In contrast, evidence supporting the effectiveness of diphenhydramine, immediate-release melatonin, and valerian is limited, with studies showing inconsistent or minimal benefits 157. Valerian, in particular, has not demonstrated significant effects on sleep outcomes .
Safety Concerns and Side Effects of OTC Sleep Aids
Safety is a significant concern, especially for older adults. Diphenhydramine and doxylamine are classified as potentially inappropriate for individuals aged 65 and older due to their risk of causing sedation, dizziness, cognitive impairment, and next-day residual effects 345. Despite these risks, more than half of older adults using OTC sleep aids take products containing these ingredients, often without awareness of the potential dangers . Dizziness or imbalance is a commonly reported side effect, and the risk of adverse effects increases with age and concurrent use of other medications 46. Melatonin is generally considered safe, but its long-term effects, especially at higher doses, are not well understood 35.
Risks of Long-Term and Inappropriate Use
Long-term and inappropriate use of OTC sleep medications is common, with some individuals developing habit-forming behaviors or using these products in ways not intended, such as for self-diagnosed sleep problems or in combination with other substances 2310. There is also evidence that frequent use of OTC sleep aids may increase the risk of serious health outcomes, such as stroke, particularly in middle-aged and older adults . Patterns of use tend to be stable over time, with some individuals consistently preferring OTC, prescription, or natural products, and those with more severe sleep problems or mental health issues are more likely to use multiple types of sleep aids 910.
Clinical Recommendations and Awareness
Given the widespread use and potential risks, clinicians are encouraged to routinely ask patients—especially older adults—about their sleep difficulties and use of OTC sleep aids 49. Increasing awareness of the safety risks and encouraging consultation with healthcare providers can help prevent misuse and reduce the risk of adverse effects 49.
Conclusion
OTC sleep medications are commonly used, but their effectiveness is often limited and safety concerns—especially for older adults—are significant. Melatonin appears to be the most effective and safest option among OTC sleep aids, while antihistamines like diphenhydramine and doxylamine carry notable risks. Greater awareness and healthcare provider involvement are needed to ensure safe and appropriate use of these medications.
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Most relevant research papers on this topic
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 REGARDS 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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Prescription and Nonprescription Sleep Product Use Among Older Adults in the United States.
More than a third of older adults use medications or aids to help with sleep, most commonly over-the-counter aids.
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