US Pharm
. 2015;40(11):12-15.

The average person will spend one-third of his or her life sleeping. Sleep plays an important role in our health and well-being; both the quality and quantity of sleep can have major impacts on a variety of health outcomes.1,2 Sleep deprivation can lead to an increased risk of hypertension, obesity, diabetes, depression, heart attack, and stroke.2 In addition, lack of sleep represents a major cause of reduced productivity, increased healthcare utilization, increased likelihood of injury, and an overall decreased quality of life.2,3

Although there is no consensus of what constitutes enough sleep and individual needs will vary, the National Heart, Lung, and Blood Institute and the National Sleep Foundation have recommended that most adults get 7 to 8 hours of sleep a night.4,5 Unfortunately, many are not reaching this target; data collected from the National Health Interview Survey from 2008-2010 indicate that approximately 28% of adults in the United States get 6 hours or less of sleep.6 A CDC analysis of 2006 data from the Behavioral Risk Factor Surveillance System reported that an estimated 10% of adults reported insufficient rest or sleep for 14 or more days during a 30-day period.7 Decreasing sleep duration has become a public health concern; for the first time, sleep has been included as a national health priority in Healthy People 2020.8

Sleep insufficiency can be attributed to many societal factors such as work schedules, lifestyle, travel, and round-the-clock access to technology. But if patients are spending enough time in bed and are still waking up tired, they may be suffering from a sleep disorder. Sleep disorders include issues with falling or staying asleep, waking up too early or too late, and problems with poor sleep quality.9 An estimated 50 to 70 million Americans have some type of chronic sleep or wakefulness disorder, which may cause significant impairment of daytime functioning.2

The most prevalent sleep disorder is insomnia, affecting 10% to 20% of the adult population, with a higher prevalence in women, the elderly, and patients with psychiatric or other medical disorders.10,11 Insomnia accounts for more than five million physician office visits and 60 million prescriptions annually.1 The condition is characterized by chronic dissatisfaction with sleep quantity or quality that is associated with difficulty falling asleep, frequent nighttime awakenings with difficulty returning to sleep, and/or awakening earlier in the morning than desired, resulting in some form of daytime impairment, such as daytime sleepiness, impairment in functioning, and/or mood disturbances.12,13 This sleep difficulty occurs at least 3 nights per week and is present for at least 3 months despite adequate opportunity to sleep.13 Insomnia differs from sleep deprivation by not being defined by a specific sleep amount; individuals have difficulty sleeping despite having ample opportunity to sleep.2

Normal Sleep Cycle

Normal sleep is made up of two alternating stages, non-rapid eye movement (NREM) sleep and
rapid eye movement (REM) sleep. Individuals experience four to six NREM-REM cycles a night, with each cycle lasting between 70 and 120 minutes. NREM is divided into four stages. Stage 1 sleep is known as the transitional phase, where the patient is transitioning from wakefulness to sleep. Stage 2 sleep is where approximately 50% of total sleep time is spent. This stage can be described as light sleep and provides rest for the muscles and brain. Stages 1 and 2 have the lowest arousal threshold. Stages 3 and 4 are collectively known as slow-wave sleep (SWS), delta sleep, deep sleep, or restorative sleep. These two stages have a very high arousal threshold and are believed to be required for physical restoration.2,14-16

REM sleep is also known as paradoxical sleep because it has features of both light and deep sleep. The first REM period occurs approximately 90 minutes after falling asleep. The duration of REM sleep increases while deep sleep decreases with each cycle. During this stage, the eyes move rapidly while respiration and heart rate become irregular, body temperature lowers, and limb muscles are temporarily paralyzed. Dreams are very common in this stage. REM sleep is required for cognitive restoration.2,14-16

Etiology of Insomnia

Current research suggests that insomnia is predominantly thought of as a disorder of hyperarousal, or an abnormality in the wake-arousal system.12 Many factors have been identified that can cause an imbalance in the wake-arousal system, such as lifestyle, environmental, anxiety, medical factors, genetics, and immune factors.

One model utilized to help better understand these factors is the “3Ps,” which are predisposing, precipitating, and perpetuating.17 Predisposing factors are not sufficient on their own to produce insomnia, but rather serve as a contributing factor, causing the occasional night of poor sleep. These factors include genetics, personality traits, and social factors. Insomnia symptoms are triggered by various precipitating factors that may or may not be self-limiting. If the factor is improved or resolved, the symptoms of insomnia will also be resolved. Some precipitating factors include medical or psychiatric conditions, stressful events, shift work, and medications. Medications that cross the blood-brain barrier can either inhibit or increase arousal.18 TABLE 1 lists common drugs that can cause insomnia.11,13 If these factors do not resolve, patients will begin to develop maladaptive behaviors and attitudes about sleep, perpetuating their insomnia, and thereby leading to chronic insomnia.

Insomnia can be classified as episodic, persistent, or recurrent.13 Episodic insomnia includes symptoms that last at least 1 month but <3 months. Persistent insomnia is described as having symptoms that last for 3 months or longer. A patient with recurrent insomnia is someone who has experienced two or more episodes within the space of 1 year.

Self-Care Options

Many patients experiencing a sleep disorder such as insomnia will approach the pharmacist seeking advice on how to best approach their sleep difficulties. It is important for pharmacists to accurately assess a patient to differentiate a sleep disturbance from insomnia. Questions such as “how long does it take you to fall asleep?” and “how many hours do you sleep?” should be compared to the patient’s normal sleep patterns. When there are inadequate opportunities to sleep, this is representative of sleep disturbances. There are several questionnaires, such as the Epworth Sleepiness Scale, that can be used to help this discussion.19

Sleep Hygiene: The first approach to the treatment of insomnia should include nonpharmacologic interventions. This includes addressing sleep hygiene and stimulus control.20 Sleep hygiene includes recommendation of various behavioral and environmental changes to help promote sleep. Examples include maintaining a regular sleep schedule; adjusting the bedtime environment to decrease stimuli; and avoiding alcohol and nicotine near bedtime, caffeine after noon, daytime naps, and heavy meals close to bedtime. Stimulus control is meant to help the patient reconnect the bedroom and bed with sleep.20 Patients should be advised not to go to bed until they are sleepy; to use the bed primarily for sleep; to avoid reading, watching TV, or using electronics while in bed; to leave the bedroom if they are unable to fall asleep for longer than 20 minutes; and to keep a fixed wake time in the morning.

OTC Sleep Aids

Nonprescription medications are frequently used to help treat insomnia-related symptoms. In 2014, OTC sales for sleep aids reached $418 million.21 None of the available OTC products are indicated for the management of chronic insomnia or recommended for long-term use due to lack of efficacy and safety data.19 Patients should be educated regarding the limited efficacy and safety of these products when inquiring about the use of sleep aids.

Antihistamines: Most products marketed for sleep disturbances are either single-entity antihistamines or products containing an analgesic in combination with antihistamines for those patients whose insomnia is a result of pain. The FDA has limited the active ingredient for OTC sleep aids to the first-generation anti-histamines diphenhydramine and doxylamine.22 There are many OTC products available under various brand names that contain diphenhydramine as an active ingredient, which can potentially confuse patients. In 2002, the FDA required manufacturers to place a warning on all products containing diphenhydramine, advising patients not to use oral OTC diphenhydramine products with any other product containing the drug, including topical products.23

Antihistamines can help relieve the symptoms of insomnia by promoting sedation, decreasing the time to sleep onset. However, use of these agents should be limited because of their potential for adverse effects from their anticholinergic properties, particularly a reduction in cognitive function, day-after sedation, development of tolerance, and interaction with other medications.24,25

Melatonin: Melatonin is a natural hormone that is produced by the pineal gland and plays a major role in the control of circadian sleep processes; it is a sleep regulator and a signal of darkness in humans.24,26 Available research data have shown melatonin’s ability to help increase total sleep time in patients suffering from sleep restriction or altered sleep schedules, to relieve daytime fatigue associated with jet lag, to reset the body’s sleep-wake cycle, and to reduce the time patients take to fall asleep.27 Meta-analyses have also documented melatonin to significantly reduce sleep-onset latency, increase total sleep time, and improve overall sleep quality in patients with primary sleep disorders.28,29

Currently, melatonin is not regulated by the FDA; it is considered a dietary supplement and is available as immediate- and slow-release preparations, with doses ranging from 0.1 to 5 mg. It has a relatively safe side-effect profile; however, further studies with high quality and large sample sizes are needed to increase confidence in its routine use for the treatment of insomnia.27

Valerian: Many herbal products appear to have sedative properties. The most extensively studied product is valerian, which has been used for more than 2,000 years for the treatment of nervous unrest, stress, and sleep disorders.30 Evidence suggests that with repeated administration (at least a 2-week course), valerian produces a mild sleep-inducing effect, reducing time to sleep onset, promoting sleep maintenance, and potentially improving sleep quality.30-32 Valerian has been found to be generally safe; the rare adverse events reported include gastrointestinal upset, contact allergies, headache, restless sleep, and mydriasis.22,31 Despite these findings, methodological problems found in many of the studies limit these findings and clinical application of this agent.


Insomnia has become a public health concern that can have a significant impact on a patient’s well-being physically, functionally, and psychologically. It is a disorder that remains underreported and undertreated. Pharmacists are in a unique position to improve sleep health management by reviewing the patient’s medication history and referring patients to their healthcare provider when symptoms of insomnia are present. Pharmacists will also be able to discuss and recommend nonpharmacologic interventions such as sleep hygiene and stimulus control to help improve sleep. If a patient does decide to use one of the available OTC products, pharmacists will be able to counsel the patient on the appropriate use and expectations, and most importantly, to avoid chronic use of OTC sleep aids.



People with insomnia have trouble falling or staying asleep and may wake up earlier than desired. They do not feel rested no matter how much they slept, and they sometimes feel tired, groggy, anxious, or irritable throughout the day. This lack of sleep can also increase the risk of other health problems, such as high blood pressure, obesity, diabetes, depression, heart attack, and stroke.

Sleep Hygiene

The best way to improve insomnia is to practice good “sleep hygiene,” which describes habits and practices that lead to sleeping well on a regular basis. Many people can greatly improve the quality of their sleep just by using sleep hygiene techniques. Some examples of these techniques include:

  • Following a regular sleep schedule
  • Avoiding afternoon naps and the use of electronics prior to bed
  • Avoiding coffee after 12 pm and heavy meals close to bedtime
  • Not smoking
  • Exercising at least 5 hours before bedtime
  • Keeping a peaceful sleeping environment.

OTC Treatments

Nonprescription sleep aids are often used to help manage symptoms of insomnia. The active ingredient in these products is an antihistamine, such as diphenhydramine or doxylamine. Antihistamines can help the symptoms of insomnia by promoting sedation and decreasing the time to sleep onset. They can be helpful if taken approximately 30 minutes before desired bedtime. However, continued use of these medications is strongly discouraged. They carry many side effects and have not been shown safe or effective when used long term. They also should not be used in patients who are aged >65 years or have glaucoma, difficulty urinating, prostate enlargement, or thyroid disorders.

Lastly, since insomnia may be a symptom of another medical condition, it is important to speak with your doctor or pharmacist before trying one of these products.

Dietary and Herbal Supplements

Dietary and herbal supplements, such as melatonin and valerian, are sometimes used to help manage insomnia. However, they are not regulated by the FDA and have not been widely studied for safety or efficacy. Melatonin is a natural hormone produced in the body that plays a role in the sleep-wake cycle. It may be useful for people with altered sleep schedules or jet lag. Melatonin has been shown to reduce time to sleep, increase overall sleep time, and improve sleep quality.

Valerian is an herbal product that has been used for over 2,000 years for the treatment of nervous unrest, stress, and sleep disorders. With continued use over at least 2 weeks, valerian may promote better sleep. It is generally safe, but has been shown to cause stomach upset and headache. Valerian can be taken as a tablet or drunk as a tea. Before taking these products, ask your doctor or pharmacist if they are right
for you.

Remember, if you have questions, Consult Your Pharmacist.


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