Article Archive
March/April 2016

Over-the-Counter Sleep Aids
By Steven M. Albert, PhD, MS; Thomas Roth, PhD; Michael Vitiello, PhD; Michael Toscani, PharmD; and Phyllis Zee, MD, PhD
Today's Geriatric Medicine
Vol. 9 No. 2 P. 20

Significant numbers of older adults report difficulties with sleep. Providers must carefully assess patients, their specific complaints, and the risks and benefits related to possible remedies.

Getting a good night's sleep can be challenging for older adults with chronic medical conditions or pain, which often interfere with sleep. Many older adults and their caregivers turn to over-the-counter (OTC) sleep aids. However, these products are indicated only for occasional difficulty with sleep and not for chronic use. Also, their safety and efficacy have not been well established in general, and not in older adults specifically.

Currently available OTC sleep aids containing diphenhydramine or doxylamine may not be appropriate for older adults because of a number of "next day" effects, such as daytime sedation and compromised cognitive function, which may lead to falls and car crashes. These OTC sleep aids may also increase the risk of anticholinergic adverse events, such as blurred vision, constipation, dry mouth, urinary retention, and increased intraocular pressure. Safe and effective use of OTC sleep aids requires some care and should be informed by a proper understanding of sleep in old age, appreciation of the risks and benefits of medication use to treat sleep problems, and appropriate assessment by health care professionals.1

Sleep in Old Age
Sleep is a biological imperative, but the optimal amount of sleep varies by age group, ranging from more than 15 hours per day for infants to between seven and eight hours for older adults.2 Sleep can be disturbed for a variety of reasons, including extrinsic and intrinsic factors. Extrinsic factors include a decrease in periodic environmental stimuli (eg, exposure to sunlight), inactivity, and ambient factors, such as excessive noise and light during the sleep period, as well as self-imposed sleep restriction. In hospital and institutional settings, nursing care activities throughout the night can disrupt sleep. Intrinsic factors include medical conditions and associated symptoms, such as pain, as well as medications used to manage these conditions. Other intrinsic factors include alterations in the internal circadian clock and primary sleep disorders, such as narcolepsy, parasomnias (eg, nightmares, night terrors, sleepwalking, confusion upon arousal), and sleep-disordered breathing/sleep apnea.

Insomnia should be distinguished from sleep disturbance. Insomnia is a disorder defined by having difficulty sleeping (difficulty falling asleep or staying asleep, or not feeling rested after sleeping), which occurs despite adequate opportunity and circumstance for sleep, is associated with daytime impairment or distress, and which occurs at least three times per week for at least one month.3

The Diagnostic and Statistical Manual of Mental Disorders, 5th Edition further distinguishes between insomnia lasting three months or longer, "chronic insomnia," and "short-term insomnia" of less than three months. Sleep disturbance, by contrast, is difficulty sleeping one to two nights in one week over two weeks and is not specific with respect to functional effects or circumstance. It can be the result of an acute event (such as injury, anxiety, or jet lag) or a symptom of other sleep disorders. OTC sleep aids are indicated only for sleep disturbance (occasional sleeplessness), not insomnia.

A major challenge in investigating sleep health and OTC sleep aids is confusion between insomnia and sleep disturbance. Unfortunately, surveys of sleep health do not typically distinguish between the two. Population-based surveys suggest that older adults on the whole report better sleep than younger people. For example, the proportion of people reporting difficulty sleeping six days or more in a two-week period declines with age.4 Among women aged 18 to 64, between 20% and 25% report difficulty sleeping six or more days in a two-week period; at ages 65 and older, the proportion drops below 20%, and is lowest among women aged 80 and older, with only 17.7% reporting this degree of sleep disturbance.

Yet this finding should be interpreted in light of other studies suggesting changes in the ways older adults sleep.5 The nature and chronicity of sleep disturbance vary with age. One study found older adults are more likely than younger people to report early morning awakenings and daytime sleepiness. Self-reports of less sleep disturbance in old age also stand in contrast to declines in many objective sleep parameters, such as total sleep time and slow-wave sleep, as indicated by polysomnography.6 On the other hand, older adults have an advantage that may favor higher sleep quality. They face fewer of the psychosocial challenges that affect sleep, such as childbearing and work, and are less likely to use technologies associated with interruption of sleep, such as smartphones and other devices.

National surveys assessing sleep health rely largely on telephone interviews of people residing in the community and thus necessarily exclude older adults in the poorest health, who are less likely to participate in surveys and more likely to reside in skilled care facilities. This exclusion may inflate self-reports of sleep quality among older adults but also supports an important conclusion about sleep and aging. Sleep disturbance is not a normal feature of aging.7 Healthy older adults experience much less sleep disturbance than older people with multimorbidities.6 In general, the more chronic medical conditions and the greater their severity, the worse people sleep.8 Diseases associated with poor sleep include diabetes, cardiovascular disease, respiratory diseases, mood disorders, cognitive decline, pain conditions, and neurologic disorders.9

On the other hand, poor sleep in old age has a significant impact on daily life and function. Documented impacts of poor sleep in older adults include difficulty sustaining attention, slowed response time, and impairments in memory and concentration;10 decreased ability to accomplish daily tasks;11 increased risk of falls;12 inability to enjoy social relationships; increased incidence of pain and reduced quality of life;13 increased risk of traffic accidents;14 increased consumption of health care resources;15 and shorter survival.16

How common is sleep disturbance in old age? We can begin to address the question using the National Health and Wellness Survey (NHWS) sleep medication substudy.17 The NHWS is an Internet-based, institutional review board-approved health survey of those aged 18 and older. A total of 75,000 adults participated in the 2013 wave of the survey, which is weighted to reflect the total US adult population of 223.8 million aged 18 and older. Among older adults aged 65 and older, about 40% reported no sleep problems in the last 12 months, and about 10% reported diagnosed insomnia or primary sleep disorders (narcolepsy, parasomnias, and sleep-disordered breathing/sleep apnea, or circadian rhythm disorder). The remaining one-half reported at least some sleep problems over the past year. Drilling down to sleep problems with likely clinical significance (ie, sleep problems respondents consider "insomnia" or make sleeping "difficult") allows a first look at the prevalence of sleep disturbance short of diagnosed insomnia. Of the 41.3 million US adults aged 65 and older, 6.3 million or 15.3% reported sleeplessness with insomnia/sleep difficulties. Notably, of the 6.3 million, 1.1 million, or 17.5%, reported the use of an OTC sleep aid.

Age Differences and Recourse to OTC Sleep Aids
In the NHWS, younger and older adults differ in reports of sleeplessness in the past 12 months. Limiting analyses to individuals without diagnosed insomnia or primary sleep disorders who nonetheless report insomnia/sleep difficulties shows that age groups differ in reports of difficulty falling asleep (74% aged 18 to 64, 65% aged 65 to 74, and 62% aged 75 and older) and waking during the night (52% aged 18 to 64, 63% aged 65 to 74, and 63% aged 75 and older). The groups likewise differ in reports of poor quality sleep, with older adults less likely to report poor quality sleep: 48% aged 18 to 64, 28% aged 65 to 74, and 26% aged 75 and older.

Do younger and older people differ in treatments for sleep difficulty? Not really. In all age groups, about one-half of the people reporting sleep difficulties reported the use of a prescription sleep aid, an OTC product, or a supplement. Among the three age groups, about 18% reported the use of an OTC sleep aid. The most commonly used product was the herbal supplement melatonin, followed by Tylenol products (which may contain diphenhydramine), and Benadryl/diphenhydramine. The most commonly used prescription sleep aids were zolpidem (Ambien), followed by trazodone hydrochloride (trazodone, an off-label use), and alprazolam (Xanax, off-label).

However, while younger and older adults did not differ in reported sleep difficulties or recourse to OTC sleep aids, the age groups used OTC products very differently. Product labeling for diphenhydramine and doxylamine advises patients to stop use and consult a heath care provider if sleeplessness persists for more than two weeks. However, a large number of older adults reported chronic use. When asked how many times they used OTC sleep aids, 37% of older adults aged 65 to 74 and 47% aged 75 and older reported using the products 15 days or more in the past month. Among adults aged 18 to 64, the proportion was much lower at 21%. Older adults using OTC sleep aids were also more likely to be taking concomitant anticholinergic medications (23% aged 18 to 64, 33% aged 65 to 74, and 44% aged 75 and older).

Thus, older people are about twice as likely to take OTC sleep aids for 15 or more days per month, a sign of potentially inappropriate use. Is this because they are using OTC products to treat chronic insomnia rather than more mild occasional sleep disturbance? If so, why aren't they diagnosed with chronic insomnia and receiving more appropriate therapy? Or, if not insomnia, why the excessive use? Is it because they are taking OTC sleep aids mainly to treat other symptoms, such as pain? Is drug tolerance driving the continued use? Or is this misuse unintentional and simply a byproduct of other factors? Research to investigate the ways older people use OTC products would be valuable for clarifying this source of potential morbidity.

Risks and Benefits of Medication Use to Treat Sleep Problems
All available OTC sleep aids include diphenhydramine or doxylamine, which are first-generation antihistamines approved by the FDA either alone or in combination with other products such as OTC analgesics for occasional disturbance. Diphenhydramine is found in the majority of products under a variety of brand names, including Nytol, Sominex, Tylenol PM, Excedrin PM, Advil PM, Unisom SleepGels, and ZzzQuil. Doxylamine is found in Unisom SleepTabs, Equaline Sleep Aid, and GoodSense Sleep Aid. Other products, such as Benadryl and a variety of pain relief-sleep combinations, also contain diphenhydramine.

The effects of diphenhydramine or doxylamine may be more pronounced in older people because their slower metabolism and reduced clearance may lead to prolonged medication half-lives and higher peak concentrations. For example, in one study the half-life of diphenhydramine was 9.2 hours in younger adults (mean age 31.5 years) but 13.5 hours in older adults (mean age 69.4 years).18 Other studies confirm these differences. As a result, circulating diphenhydramine is likely present when older people awaken in the morning, which can cause sedation, compromised cognitive function, dizziness, or falls.

More generally, diphenhydramine or doxylamine are "sedating antihistamines" that were not initially designed for treating sleep problems. They were marketed before the FDA began the OTC Drug Monograph process in 1972, so the drugs were grandfathered and not subject to requirements for randomized placebo-controlled trials. The most positive published trial found that diphenhydramine 50 mg significantly improved patient reports of disturbed sleep, including sleep latency and reports of feeling more rested the following morning. Patients in the trial reported a preference for diphenhydramine over placebo despite experiencing more side effects.19 Other published data using both patient reports and objective measures of sleep, however, were less positive.20 There are no published controlled trials examining doxylamine for the treatment of sleeplessness. The Beers Criteria recommend avoiding these products in the older adult population.21

Appropriate Assessment by Health Care Professionals
Pharmacists are uniquely positioned to provide older adults with education about OTC sleep aids and make medical referrals. They may be the only health care providers who interact with patients regarding OTC purchases. While consumers can purchase OTC sleep aids without consulting pharmacists, greater involvement of pharmacists and pharmacy technicians at the point of sale may reduce older adults' unintentional misuse.

Educational tools are available to help pharmacists address common challenges for older adults with sleep health issues, such as Silver Market Training Modules developed by The Gerontological Society of America ( In the "Worried Well" case, an older woman reports she is not sleeping as well as she used to, but upon questioning, reveals her nighttime sleep is age appropriate and daytime function undisturbed. In "Acute Sleep Disturbance," a patient coping with a recent bereavement, a clear precipitating factor, experiences disturbed sleep. "Chronic Insomnia" features a patient with frank sleep maintenance insomnia. Pharmacists are counseled to discourage OTC for the first case, to consider short-term OTC in consultation with another health care provider for the second, and to refer the third to a health care provider for possible prescription medication. More generally, the modules suggest ways pharmacy professionals can inquire about sleep hygiene practices, the nature and duration of sleep disturbance, use of other therapies (both prescription and OTC, including supplements), and alcohol.

Older adults with sleep disturbance use OTC sleep aids as commonly as younger people, but they are more likely to use the products inappropriately and are at higher risk of adverse events related to the products' sedating and anticholinergic properties. Because so many older people use diphenhydramine or doxylamine, they evidently find value in the products for addressing sleep disturbance. However, the potential for extended exposure due to longer half-lives and the risk of hangover or next-day effects is worrisome because of the risk of falls and impaired neurocognitive function. Pharmacoepidemiologic studies would be valuable to assess this risk. Likewise, randomized controlled trials are needed to assess the efficacy and safety of OTC products in addressing sleep disturbance.

The pharmacy community is in an ideal position to help optimize older adults' safe and effective use of OTC sleep aids. Educational materials will go some way in helping pharmacy professionals and other members of the geriatric care team work with older adults to choose OTC sleep aids wisely. A bigger challenge lies in reconfiguring the community pharmacy to support greater consultation with patients and health care professionals as part of the purchase of OTC products.

— Steven M. Albert, PhD, MS, is a professor and chair of the department of behavioral and community health sciences at the Graduate School of Public Health at the University of Pittsburgh.

— Thomas Roth, PhD, is the director of research and division head of the Sleep Disorders and Research Center at the Henry Ford Health System.

— Michael Vitiello, PhD, is a professor at the Center for Research on Management of Sleep Disturbances and Northwest Geriatric Education Center at the University of Washington.

— Michael Toscani, PharmD, is a research professor at Rutgers Institute for Pharmaceutical Industry Fellowships at the Ernest Mario School of Pharmacy and an American Pharmacist Association fellow.

— Phyllis Zee, MD, PhD, is the Benjamin and Virginia T. Boshes professor in neurology and director of the Center for Circadian and Sleep Medicine at the Northwestern University Feinberg School of Medicine.

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