US Pharm. 2009;34(4)(OTC suppl):8-11. 

The need for sleep is one basic physiologic factor that unites all humans, in that it activates the processes that restore the body from the day’s exertions.1 It is virtually guaranteed that everyone will suffer from insomnia at some point in their lives.2 For this reason, pharmacists should be prepared to counsel patients about insomnia and its treatment with nonprescription products. 

The Sleep Cycle

The human sleep cycle has been found to consist of three distinct phases: light sleep, delta (deep) sleep, and rapid eye movement (REM) sleep.3 Light sleep is non-REM sleep and is further subdivided into two stages. Stage 1 sleep is the period between wakefulness and first onset of early sleep. In stage 2 of light sleep, also known as the transition phase, the person experiences bradycardia, relaxation of the muscles, and a drop in body temperature. Delta sleep, which is subdivided into stages 3 and 4 sleep, is the time of rest and restoration. Eventually, patients begin to experience REM sleep, in which there is active dreaming, rapid eye movements, tachycardia, tachypnea, and increased brain activity. 

Definition of Insomnia

The National Institutes of Health (NIH) convened a historic conference in 2005 to explore the nature of chronic insomnia in adults.2 This was the first such conference to issue a consensus statement on insomnia since 1983.4 The conference was unique in looking at insomnia as a medical condition in itself, rather than just a symptom.4 The conference defined insomnia as “complaints of disturbed sleep in the presence of adequate opportunity and circumstance for sleep.” The NIH stated that insomnia has three features: 1) difficulty in initiating sleep; 2) difficulty in maintaining sleep; or 3) waking up too early. The NIH also included a fourth characteristic: sleep that is perceived to be nonrestorative or of poor quality.2 

Patients inquiring about self-care should be questioned about their definition of insomnia. The typical perception of insomnia is that the person lies down to sleep but barely closes the eyes until the time to awaken. This is not the case with most patients who seek self-care. Rather, patients usually complain that they did not sleep long enough, did not fall asleep soon enough, or that they experienced too many nighttime awakenings, conditions that are amenable to nonprescription products. 

Prevalence of Insomnia

Insomnia is a problem for 20% to 50% of adults in the United States.2,3 However, perhaps 75% of adults have disturbed sleep for a few nights weekly.5 Chronic insomnia affects 9% to 15% of people.5 As many as 57% of the elderly not living in institutions report insomnia.3 

Subtypes of Insomnia

The NIH conference differentiated types of insomnia based on duration. Insomnia lasting less than 30 days is not considered to be clinically important and is referred to as acute insomnia. However, should insomnia last 30 days or more, the impact and gravity increase, and the condition becomes chronic insomnia. Pharmacists should not advise self-treatment for insomnia that has lasted longer than 2 weeks. 

Etiologies of Insomnia

The etiologies of insomnia are widely diverse. They range from minor upsets of little consequence to major life stressors that can neither be avoided nor forgotten.6 There are two broad categories of insomnia in regard to etiology.7,8 Primary insomnia is not caused by a medical problem, nor is it an adverse reaction to medications or any form of medical therapy. It is a medical condition in and of itself. Primary insomnias are invariably short-term, being caused by such insignificant stressors as a room that is too hot or too cold, a mattress or pillow that is uncomfortable, construction noise, worry about an exam or other event the next day, or too much to eat or drink right before bed. Insomnia due to these causes usually resolves the next night when the underlying problem has resolved. Sleep hygiene measures are very effective when necessary. Some patients have chronic primary insomnia, a condition in which the patient is hyperactive, hyperaroused, and often worries excessively.4 

The more common type of insomnia is the secondary form, experienced by at least 80% of those with insomnia.7 Secondary insomnias persist longer than primary insomnia and arise from some other problem, usually an illness, or as an adverse effect of a medication. Etiologies causing short-term secondary insomnia are usually those that have greater impact on one’s life than those that can cause primary insomnia. They include an upcoming marriage or divorce, marital or family friction, financial worries, a pending move, a new job, a promotion or demotion at work, and starting or ending one’s academic career. The patient may have a relatively minor medical problem, such as a strain, sprain, dermatologic condition (e.g., contact dermatitis, tinea pedis), gastroesophageal reflux disease, or toothache. By their very nature, these problems will probably not be resolved successfully the next day, but they usually resolve in a relatively short period. 

Patients may also experience long-term secondary insomnia. The etiologies are even more severe than those that can produce short-term insomnia, including long-term sexual or physical abuse, receiving a devastating medical diagnosis for oneself or a loved one, or the death of a spouse or child. Medical conditions that can cause secondary insomnia include dementia, arthritis, delirium, chronic obstructive pulmonary disease, diabetes, congestive heart failure, depression, chronic pain, Parkinson’s disease, malignancies, chronic kidney disease, and incontinence.1,3,9 Medications that can cause insomnia include clonidine, corticosteroids, bronchodilators, levodopa, phenytoin, pseudoephedrine, theophylline, and antidepressants (e.g., bupropion, selective serotonin reuptake inhibitors, venlafaxine).1 Diuretics taken at night cause nocturnal urination.1 

Epidemiology of Insomnia

Insomnia increases with age.3 Despite spending 10 to 12 hours in bed (as opposed to 7-8 hours for younger patients), older adults report sleeping only 50% to 70% of the time in bed, rather than 85% to 90% as seen in younger patients. Older adults also take more time than younger patients to fall asleep (more than 15 minutes), have more fragmented sleep, have more nocturnal arousals and awakenings, and have less REM sleep. 

Women experience insomnia with greater frequency than men of the same age.3,5 Those with depressive disorders are more likely to report insomnia.5 

Consequences of Insomnia

Insomnia and delayed sleep onset increase the risk of mortality during the following 2-year period in geriatric patients.1 Sleep disruption impacts the individual’s ability to function as expected and desired the following day.2,10 Almost half of adults report that tiredness resulting from insomnia affects their daily activities.9 Insomnia can result in decreased efficacy in the workplace, as it impairs such performance measures as visual-spatial reasoning and long-term memory. The quality of life is lowered, and there is a concomitant increase in absenteeism, falls, and accidents.4 Insomnia increases the risk of certain comorbidities, such as psychiatric disorders, particularly depression.4 In elderly patients, insomnia can lead to decreased quality of life, increased anxiety, disorientation, delirium, psychomotor retardation, impairment in intellect, disturbed cognition, increased risk of accidents and injury (due to greater difficulty in ambulating and maintaining balance), and enhanced risk of nursing home placement.11 

Nonprescription Products for Insomnia

Pharmacists are often asked about self-care options for insomnia. Assuming that the patient has attempted sleep hygiene measures without success, the next step in self-care is the use of nonprescription sleep aids.6 They may be appropriate if the condition has lasted for less than 2 weeks. However, if it has persisted for 2 weeks or longer, the patient should make a physician appointment to rule out secondary insomnia due to a comorbid condition that should be addressed. The label on these products cautions potential users that insomnia may be due to a serious underlying medical illness.6 

Nonprescription sleep aids are members of the ethanolamine group of antihistamines. This group has a pronounced tendency to sedate patients and a low incidence of gastrointestinal upset, although there is a possibility of anticholinergic, atropine-like effects. 

Since nonprescription sleep aids contain antihistamines, they are contraindicated in patients who have emphysema, chronic bronchitis, glaucoma, or trouble urinating because of an enlarged prostate gland.6 Further, they should not to be used in patients younger than 12 years of age. If a patient is pregnant or breast-feeding, she should not use them, but should ask her physician for advice. 

Patients taking nonprescription sleep aids are advised to avoid alcoholic beverages while taking the products.6 They are also cautioned not to use them if they are taking sedatives or tranquilizers, without speaking to their physician first. 

Diphenhydramine hydrochloride (HCl) was approved as a safe and effective sleep aid through the FDA OTC review (for sleep aids) that ended in 1989.6 The ingredient reduces the time to fall asleep for those with occasional sleeplessness. The recommended dose for those aged 12 years and above is 50 mg at bedtime. Diphenhydramine HCl is the ingredient in such sleep aids as Sominex Tablets, Simply Sleep Caplets, and Unisom SleepGels  
(TABLE 1). 

In 2002, the FDA finalized a rule for all diphenhydramine sleep aids that labels must caution the patient not to use these drugs with any other product containing diphenhydramine, even one used topically.6 This rule was intended to prevent additive antihistamine toxicity, with symptoms such as dilated pupils, flushed face, hallucinations, ataxic gait, and urinary retention. 

The only other ingredient proven safe and effective for sleep is doxylamine succinate, which was approved for OTC sales in 1978 through the new drug application process.6 Doxylamine shares most of the warnings of diphenhydramine, with the exception of the additive diphenhydramine use precaution. The dose is 25 mg before bedtime. It is the ingredient of Unisom SleepTabs (TABLE 1). 

The use of the Unisom trade name can cause confusion.6 If the patient has used a sleep aid containing diphenhydramine for several days with inadequate benefit, he may wish to try another antihistamine for the remainder of the 2-week self-care period. However, if the initial product tried was Sominex and the patient incorrectly chooses Unisom SleepGels as the second-choice product, he is still only getting diphenhydramine. The pharmacist should counsel him to choose Unisom SleepTabs instead, which contain doxylamine.

Unproven Therapies for Insomnia

Hundreds of products for insomnia have been sold through the years, but their manufacturers were effectively stopped from making unwarranted claims by the FDA until 1994, when the Dietary Supplement Health and Education Act (DSHEA) was enacted.6 In the post-DSHEA years, pharmacists again saw hundreds of “dietary supplements” being actively promoted for insomnia. The FDA is not allowed to require that manufacturers or promoters prove their products’ safety and efficacy, so consumers using them are ingesting unproven substances with unknown adverse effects. These products are not proven to promote sleep in any way known to legitimate science, using FDA approval as the standard of excellence in evaluating medical claims. Thus, they should neither be stocked nor sold by pharmacists for any use. 

Melatonin is one such unproven product promoted for insomnia. Melatonin is a naturally occurring hormone produced mainly in the human pineal gland. Despite numerous studies attempting to demonstrate its worth in sleep disorders, it has not yet been proven safe and effective in treating any condition.6,12,13 Until the FDA receives appropriate research and approves melatonin for this use, it should not be recommended. 

Valerian is an herbal supplement that is identical to all other herbal dietary supplements in that it is of unknown safety and efficacy.6,13,14 It should not be recommended for any use. Other homeopathic products for sleeplessness include such unproven ingredients as passion flower, oats, hops, and chamomile. None of these ingredients has ever been proven to promote sleep, especially not when diluted to the point of placebo, as is the practice in homeopathy. Homeopathic products should neither be stocked nor recommended until they are proven safe and effective.

Sleep Hygiene

Pharmacists can provide various bits of information on lifestyle changes that the patient might institute to reduce the risk of primary insomnia.4,6,9 For instance, patients should be taught to go to bed and arise at approximately the same time each day. The body becomes adapted to this schedule and cooperates in initiating sleep and wakefulness. People should avoid the habit of staying awake later than normal on weekends or trying to sleep in for another couple of hours. When Monday arrives, the body is not ready to assume its normal sleep times. 

Patients should not go to bed hungry, but ingesting a heavy meal too close to bedtime should also be avoided due to the risk of reflux.6 Caffeine is a major cause of insomnia, and patients should attempt to eliminate it from their diet completely, especially after noon. This includes caffeinated soft drinks, tea, coffee, and chocolate. Alcohol disrupts sleep, causing those under its influence to wake up more often than normal during the second half of the night. Its ingestion should be halted to see if it might be causal. Nicotine has stimulant properties and should be avoided at all times. Drugs of abuse, such as crack, methamphetamines, and marijuana, may disrupt sleep and should be avoided. Pharmacists selling nonprescription medications with stimulant properties (e.g., pseudoephedrine, phenylephrine, ephedrine, epinephrine asthma products) should warn patients that they may cause sleeplessness and advise them against taking doses too close to bedtime. 

During the daytime, some patients with insomnia feel the need to take a nap. On the surface, this seems like a logical way to prevent the buildup of a sleep debt, but it can inhibit the need to sleep at night, since the sleep debt is not as profound.6 Thus, it is better to resist the urge to nap during the day. 

Patients should approach bedtime as an occasion to slowly relax, not engaging in activities that require a great deal of concentration or produce anxiety (e.g., video games).6,9 Patients may find a warm bath, relaxation exercises, or reading a book to be restful. They should go to bed when they begin to feel drowsy. When first lying down, they should avoid ruminating over the events of the day, trying to solve problems, or thinking about the various issues that complicate life.9 If they lie down but cannot sleep after 10 minutes, they should get up and read or watch television. They should attempt sleep when they again feel drowsy and follow the 10-minute rule as many times as needed. The goal of this exercise is to see the bedroom as a place where patients obtain restful sleep rather than as a place where they toss and turn for hours. The room should be appropriately darkened and quiet. Furthermore, the bedroom should never be used as the destination where marital fighting occurs. If all of these interventions fail to produce sleep, nonprescription mediations may be appropriate. 


Insomnia is a widespread condition, and it usually stems from minor problems easily addressed by sleep hygiene measures. If these are ineffective, the patient may try a 2-week trial of nonprescription products containing either diphenhydramine or doxylamine, unless they are contraindicated. If the insomnia persists for more than 2 weeks, the patient should be referred to a physician. 


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