US Pharm. 2012;37(1):12-15. 

Millions of Americans experience one or more sleep disorders. Pharmacists can provide information on nonprescription products and devices that may help relieve the problems, as well as simple lifestyle changes that can help prevent them. 

Meaning of Insomnia

The common lay definition of insomnia is lying in bed with the eyes wide open all night.1 However, when patients complain of insomnia, they often refer to conditions that are more subtle.2 For instance, the patient may simply have experienced difficulty in falling asleep, but eventually slept well. Other patients fall asleep quickly and awaken occasionally during the night. These patients may complain that they awaken too often or are unable to easily return to sleep. Others may also sleep normally, but find that they often awaken too early in the morning and spend too much time awaiting a return to sleep that never comes. Finally, patients may sleep for a normal 8-hour stretch but feel as though the sleep did not refresh them. 

Prevalence

One-fourth of Americans experience occasional problems sleeping, and 10% report long-term issues.3 Insomnia, the most common of all sleep disorders, affects as many as 10% to 40% of Americans. 

Categories of Insomnia

Insomnia can be placed into two categories regarding causation. The first is primary insomnia, a less common subtype (about 20% of cases) that is not due to any other medical condition, nor is it caused by use of drugs, alcohol, or legitimate medications.4 Experts believe some of these patients may be subject to “hyperarousal,” i.e., having an abnormally high state of alertness during the day and night.5-7 In others, the insomnia may be caused by stress or emotional upset. 

Secondary or comorbid insomnia is caused by another underlying factor.7 This constitutes the remaining 80% of cases.7 Causes include psychiatric disorders (e.g., depression, anxiety, bipolar disorder); conditions causing pain (e.g., arthritis, gastroesophageal reflux disease, headache); a host of medical conditions (e.g., enlarged prostate, cystitis, chronic obstructive pulmonary disease and other lung problems, cardiac issues, hyperthyroidism, restless legs syndrome, nocturia, posttraumatic stress disorder, Alzheimer’s disease, Parkinson’s disease); and sleep pattern disruption (e.g., jet lag, sleep-wake pattern disturbances, shift work, napping during the day).2-8 Legitimate medications (e.g., thyroid supplements, ephedrine, pseudoephedrine, theophylline) and energy drinks can also cause sleep disruption.9 Illegal addicting drugs (e.g., methamphetamine, cocaine) and legal addicting drugs (e.g., nicotine, alcohol, caffeine) may be causal.10 Pharmacists can advise against use of all addicting drugs, herbals, and dietary supplements, but patients should be cautioned not to discontinue legitimate medical therapy without first speaking to their prescriber. 

Epidemiology

Insomnia is linked to age, in that older people seem to lose the ability to sleep normally, while retaining the need for sleep.2 Females experience higher rates of insomnia due to hormonal fluctuations during the menstrual cycle.4 The gender difference is more pronounced during the perimenopausal (partly due to hot flashes and night sweats) and postmenopausal periods.2,4 Hormonal changes may also be responsible for a greater reported prevalence of insomnia during pregnancy. 

Manifestations

Patients who ask to speak to the pharmacist about insomnia often exhibit noticeable symptoms of sleep deprivation, such as a low energy level, fatigue or outright drowsiness, disorientation and inability to focus on tasks, inattention, irritability, anxiety, and dark circles under the eyes.3,7 

Nonprescription Products for Insomnia

When patients ask about self-treatment of insomnia, the pharmacist should ask how long it has been a problem. Nonprescription products are not proven to be safe and effective for insomnia that has persisted for more than 2 weeks.1 This limits their use to primary, short-term insomnia. Insomnia that has lasted longer is more likely to be secondary, requiring physician evaluation. 

Nonprescription sleep products contain first-generation antihistamines, either diphenhydramine or doxylamine.1 They reduce the time needed to fall asleep for patients who have trouble doing so, relieve occasional sleeplessness, and reduce difficulty in falling asleep. The label on sleep products cautions that insomnia may be a symptom of a serious underlying medical illness. 

These OTC products must not be used in patients under the age of 12 years.1 More appropriate treatment for young patients is behavioral intervention and supportive treatment. Children should also be medically screened for a serious medical condition that inhibits sleep. 

Sleep products should never be used to intentionally sedate children. Parents/caregivers often choose diphenhydramine for this purpose, as it is readily available and widely known to be sedating. They may choose adult diphenhydramine sleep products or pediatric diphenhydra-mine allergic rhinitis products. The author once spoke to parents who gave their three small children diphenhydramine before leaving on a long car trip so the children would not talk or fight, giving the parents a more pleasant trip. Pharmacists must advise against these uses. When first-generation antihistamines are administered to children under the age of 6 years, they can cause a central nervous system (CNS) stimulation known as paradoxical excitation.1 Parents may administer repeated and increasing diphenhydramine doses to counter the stimulation and induce sedation, not realizing that the antihistamine is causing the stimulation. This could lead to anticholinergic toxicity.

Labels of nonprescription sleep products warn against use in patients who have difficulty in breathing, chronic lung disease, shortness of breath, emphysema, glaucoma, or trouble urinating due to an enlarged prostate.1 The glaucoma warning specifically refers to patients with narrow-angle (closed-angle) glaucoma, which is not as common as open-angle glaucoma. If potential purchasers do not know with certainty the condition from which they suffer, they should be urged to call their prescriber for clarification prior to unsupervised purchase of first-generation antihistamines. 

Product labels caution against drinking alcoholic beverages while using the products, and direct patients to speak to a doctor or pharmacist before use if they are taking sedatives or tranquilizers.1 Products with diphenhydramine should never be used concurrently with other products containing diphenhydramine, even those used topically. Labels also bear the general warning against use in pregnancy and by nursing females. 

Products containing diphenhy-dramine include Nytol QuickCaps, Sominex Tablets, Unisom SleepMelts, and Unisom SleepGels. NyQuil and Unisom SleepTabs contain doxylamine. Patients should be cautioned to avoid unproven therapies (e.g., acupuncture) and products that purport to be effective for insomnia, such as Neurexan (contains coffee), valerian, melatonin, and other herbals, homeopathics, or dietary supplements that are not FDA approved.11-14 

Snoring

Snoring is another sleep-related problem for which pharmacists can recommend a product.1,15,16 Snoring disrupts the patient’s sleep, but is usually more troublesome for the spouse/bed partner, and for children whose bedrooms are in close proximity. Snoring is more common in males, perhaps because they have smaller caliber airways than females. 

Most snoring is unrelated to any underlying medical condition (e.g., obstructive sleep apnea [OSA]), and is known as primary snoring. Patients predisposed to snoring include those who are overweight (due to pressure on the airways from excessive neck tissue); females who are pregnant (especially in the last trimester); those with nasal congestion from the common cold or allergic rhinitis; those with inflammation of the soft palate, uvula, adenoids, or tonsils; and those with certain anatomical predispositions (e.g., abnormal facial bones, large tongue, or prominent area at the base of the tongue).15,16 

Snoring can also be secondary to a serious condition such as OSA.1 The patient or bed partner will notice repeated episodes where there is partial or complete cessation of breathing and snoring for more than 10 seconds, ceasing when the patient abruptly gasps or sucks in air and then resumes breathing and snoring before another episode occurs. 

Patients who are able to breathe normally through the nose do not snore, since the mouth is closed.1 However, nasal obstruction forces patients to mouth breathe. Thus, opening the nasal airways may eliminate some cases of snoring. Judicious use of topical or oral nasal decongestants may accomplish this objective, although the accompanying CNS stimulation often interferes with sleep. 

Another viable method to stop snoring is the use of FDA-approved, adhesive-backed thin plastic nasal strips (e.g., Breathe Right Nasal Strips). The nose should be washed with soap and water and thoroughly dried before application to ensure proper adhesion. The strip is applied between the bridge and end of the nose, and gently rubbed with the fingers until it is securely fastened to the skin. Applying firm pressure to the ends of the strip helps secure the adhesive. When the strip is released, it gradually opens the nasal passages, so that the patient often notices an immediate improvement in breathing. 

Nasal strips should not be used over any wound on the nose, or if the skin is irritated or sunburned. The maximum time of use is 12 hours daily, and those allergic to adhesives or tape should not use them.1 If strips cause skin irritation, they should not be used. Pharmacists should instruct patients that mouth breathing is often a long-standing habit, and it may take 7 to 10 nights of strip use before the patient learns to breathe through the nose again. 

Nasal strips are available in several options to fit patient preference. Most are sized for adults, but a “kids” strip is available. Another option is color. Since patients may object to having a visible tan strip placed over the nose, less noticeable transparent strips are available. A newer version adheres to the nose at four different points, providing a more effective opening. 

PATIENT INFORMATION


Lifestyle Changes

If you have insomnia, try these helpful hints. Perhaps you go to sleep and wake up at wildly varying times. For example, you may stay up playing video games until 3 am on Friday and Saturday nights, then try to go to sleep at 10:30 pm on Sunday. Your body will not be ready for the early bedtime, and you may suffer insomnia. Instead, try to adopt a standard time to awaken and go to bed and stick to it as closely as possible. 

In addition, you may not sleep well at night but nap during the day, and then wonder why you have trouble sleeping at night. It is better to avoid naps during the day, which facilitates a normal drowsiness at bedtime. Try to avoid jobs that require periodic night shifts and rotating or alternating shifts. 

Halt all use of alcohol, nicotine, caffeine, and any legal or illegal drugs of abuse (e.g., pain tablets, meth, cocaine, marijuana). All disrupt sleep, and becoming free of addiction to any of them is an added benefit for your overall health. 

Obtain regular exercise as recommended by your physician and physical therapist. However, do not exercise too close to bedtime, as that can disrupt sleep. Instead, exercise 5 to 6 hours before bedtime. Do not go to bed hungry, but don’t eat right before bedtime either. Try to finish dinner 3 hours before bedtime. 

Never engage in physically or intellectually stimulating activities too close to bedtime. Do not play video games that require lightning-quick reflexes and intense concentration. Instead, give yourself time to wind down with more routine activities, such as reading a book, listening to soothing music, watching a favorite movie or television show, or taking a warm bath. 

If your job requires you to accomplish tasks the following day, make a checklist of those responsibilities prior to bedtime. This may satisfy your mind, preventing you from worrying about them while you are trying to fall asleep. 

Alter your bedroom so it promotes sleep. Keep the temperature comfortable, shut light out of the room, and take steps to stop noise with earplugs, or make it less noticeable with a fan or a “white noise” device. 

Nonprescription Products

If lifestyle changes do not provide relief, Consult Your Pharmacist about the use of OTC products. There are two safe and effective ingredients: diphenhydramine (e.g., Sominex, Tylenol PM) and doxylamine (e.g., NyQuil, Unisom SleepTabs). These antihistamines must be used as directed on the label. However, no herb, dietary supplement, or homeopathic product has been proven safe or effective for insomnia. 

See Your Physician

When nonprescription products should not be used (as advised by your pharmacist), it is time to see your doctor. If your physician writes a prescription, make sure to take the product only as directed. Do not take more than specified on the label. 
 

REFERENCES

1. Pray WS. Nonprescription Product Therapeutics. 2nd ed. Baltimore, MD: Lippincott Williams & Wilkins; 2006.
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14. Ernst E, Lee MS, Choi TY. Acupuncture for insomnia? An overview of systematic reviews. Eur J Gen Pract. 2011;17:116-123.
15. Snoring—adults. MedlinePlus. www.nlm.nih.gov/medlineplus/
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16. Snoring. MedlinePlus. www.nlm.nih.gov/medlineplus/
snoring.html. Accessed November 26, 2011. 

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