OTC Products for Insomnia

Ms. Terrie is a clinical pharmacy writer based in Haymarket, Virginia.

Many individuals underestimate the importance of getting a good night’s rest until they experience an episode of insomnia. Insomnia is considered to be one of the most prevalent patient complaints, ranking third after headaches and the common cold.¹ Statistics from the National Center for Sleep Disorders at the National Institutes of Health report that an estimated 30% to 40% of adults have some of the symptoms associated with insomnia within a given year, and 10% to 15% report episodes of chronic insomnia.² The incidence of insomnia is greater among older individuals and women. Many women experience sleep problems during menstruation, pregnancy, and menopause.² The frequency of insomnia increases as an individual ages and is most often attributed to some other medical condition.^1,2

According to the results of a survey conducted by the National Sleep Foundation that was released in March 2009, the number of individuals reporting problems sleeping has increased 13% since 2001, and an estimated one third of the American population reported problems sleeping due to the state of the economy and personal finances.³

In the past 8 years, the number of Americans who sleep less than 6 hours per night increased from 13% to 20%, and those who reported sleeping 8 hours or more declined from 38% to 28%.3 Furthermore, according to the survey, an estimated 40% of Americans agree that sleep is as important as a balanced diet and exercise to overall health and well-being; however, only 32% of those surveyed who report sleep problems seek the advice of their primary health care provider.³ According to a report in the March 9, 2009, issue of Archives of Internal Medicine, an estimated 50% of patients with insomnia have suffered from sleep problems for 3 years or more, and three fourths report at least 1 year of insomnia symptoms. ⁴

Causes of Insomnia

Individuals with insomnia may present with complaints of trouble falling asleep, difficulty staying asleep accompanied by episodes of frequent waking, and not feeling completely rested upon waking.¹ Several factors may cause or exacerbate episodes of insomnia, and these factors may be classified as psychological, physical, and environmental. Examples of common factors include¹:

• Stress or anxiety

• Depression

• Change in environment, routine, or schedule

• Certain medical conditions such as arthritis, congestive heart failure, gastroesophageal reflux disease, respiratory disorders, and psychiatric disorders

• Use of certain pharmacologic agents, such as antidepressants, antihypertensives, and sympathomimetic amines

• Use of caffeine, nicotine, and alcohol

Types of Insomnia

Insomnia can be classified as primary and secondary. Primary insomnia typically lasts for 1 month or more and is not directly the result of another sleep disorder, general medical condition, psychiatric disorder, or due to the use of any pharmacologic agent.^1,4 Secondary insomnia is the most prevalent form of insomnia, accounting for 8 of every 10 individuals who experience insomnia.^4-7 It is the result of another identifiable underlying source, such as certain medical conditions or pharmacologic agents.^4-7

Insomnia can be further categorized based on the duration and severity of the episodes as follows^1,6,7:

1. Transient (self-limiting and lasting less than 1 week; often caused by temporary stress, anxiety, or schedule changes).

2. Acute or short-term (lasting 1-3 weeks; often caused by prolonged stress or anxiety).

3. Chronic (lasting more than 3 weeks; often the result of medical conditions, mental disorders, or substance abuse).

Treating Insomnia

Insomnia can negatively impact an individual’s quality of life and the ability to perform daily routine tasks. Sleepdeprived individuals may experience symptoms such as irritability, difficulty with concentration, cognitive impairment, extreme fatigue, and anxiety. Before recommending treatment, the possible causes, duration, and severity of the symptoms of the insomnia should be evaluated to determine the most appropriate treatment approach.

Currently, several OTC products are available that are indicated for the treatment of transient and short-term sleep disorders in patients who occasionally have problems with sleep (see Table). Formulations available include single-entity antihistamine products containing diphenhydramine or doxylamine and products formulated as an antihistamine—analgesic combination for those individuals whose insomnia is the result of uncontrolled pain. These sleeping aids are available in a variety of dosage forms. Both diphenhydramine and doxylamine are ethanolamine antihistamines and are thought to affect sleep through their affinity for blocking histamine-1 and muscarinic receptors.¹ A host of complementary products are also on the market that include melatonin and valerian, as well as a variety of homeopathic ingredients.

Pharmacists can be instrumental in screening for potential drug interactions and contraindications prior to recommending the use of these products, as well as identifying possible medical disorders or pharmacologic agents that may be associated with or exacerbate episodes of insomnia. During counseling, patients should be reminded that OTC sleeping aids are indicated for short-term use and should only be taken for 7 to 10 days, unless otherwise directed by a physician.1 Pharmacists should always refer patients with chronic insomnia for further medical evaluation when warranted.

Patients electing to use OTC sleep aids should be advised of the potential adverse effects, drug interactions, contraindications, and precautions associated with these products. Prior to recommending any of these products, pharmacists should ascertain if the patient is an appropriate candidate for the use of OTC sleep aids, as well as ensure that patients thoroughly understand their proper use and the potential adverse effects, such as morning grogginess, dry mouth, constipation, and blurred vision.¹

Patients should be advised to adhere to the recommended dosage guidelines. Patients should also be cautioned to avoid performing certain tasks, such as driving or operating machinery, until their response to OTC sleep aids is known.¹ Patients should be reminded to avoid the use of alcohol when taking sleep aids. The use of these products are contraindicated in those patients with prostatic hyperplasia and difficulty urinating and those with glaucoma, emphysema, and chronic bronchitis.^1,8 Patients with cardiovascular disease, such as angina, may be more susceptible to anticholinergic adverse effects of OTC sleep aids and should not use them.⁸

Individuals with insomnia who are younger than 12 years of age, those 65 years of age or older, pregnant women, breastfeeding women, and those with preexisting medical conditions should consult their primary health care provider prior to using any OTC sleep aids. Patients should also be advised not to take any other sleep aid products or any products that may contain antihistamines— including using topical antihistamine products—while taking these sleep aids. In addition, pharmacists can suggest nonpharmacologic measures that may increase the likelihood of a good night’s sleep and refer patients with chronic insomnia to their primary health care provider, when warranted, to discuss the various prescription drugs available for the treatment of insomnia. â– 

References

1.

Kirkwood C, Melton S. Insomnia In: Berardi R, Newton G, McDermott JH, et al, eds. Handbook of Nonprescription Drugs. 16th ed. Washington, DC: American Pharmacists Association; 2009:869-881.

2.

Insomnia Facts. National Sleep Foundation website. http://www.sleepfoundation.org/sleep-facts-information/study-hall.

3.

One—third of Americans lose sleep over economy. National Sleep Foundation. http://www.sleepfoundation.org/sites/default/files/2009%20NSF%20POLL%20PRESS%20RELEASE.pdf.Accessed January 2, 2010.

4.

Kelly J.Insomnia last for years of left untreated. Medscape website. http://www.medscape.com/viewarticle/589428. Accessed January 2, 2010.

5.

Insomnia. Medline Plus website. http://www.nlm.nih.gov/medlineplus/ency/article/000805.htm. Accessed January 2, 2010.

6.

Types of Insomnia. Shuteye.com website

. www.shuteye.com/what-is-insomnia/types-of-insomnia.aspx.

Accessed January 2, 2010.

7.

What is Insomnia? National Heart, Lung and Blood Institute website. www.nhlbi.nih.gov/health/dci/Diseases/inso/inso_all.html. Accessed January 2, 2010.

8.

Diphenhydramine Product Information. Medscape website. http://www.medscape.com/druginfo/dosage?drugid=93203&drugname=Diphenhydramine+Citrate+Oral&monotype=default. Accessed January 2, 2010.