A Pharmacist's Guide to OTC Therapy

MARCH 01, 2007
Yvette C. Terrie, BSPharm, RPh

Insomnia Treatments

A survey conducted by the National Sleep Foundation reported that ~48% of people in the United States have occasionally experienced one or more of the symptoms associated with insomnia, while about 22% experience insomnia nightly or almost every night.1 Furthermore, the incidence of insomnia is 1.5 times greater in individuals over the age of 65, when compared with younger individuals, and is more prevalent among women than men.1

Types of Insomnia

The 2 types of insomnia are primary and secondary insomnia. Primary insomnia typically lasts for 1 month or more and is not directly the result of another sleep disorder, general medical condition, or psychiatric disorder, or due to the use of any pharmacologic agent.2,3 Secondary insomnia is the most prevalent form, accounting for 8 of every 10 patients who experience insomnia. It is the result of another, identifiable underlying source, such as certain medical conditions or pharmacologic agents.2,4

Insomnia can be further categorized based upon the duration and severity of the episodes as follows3,5:

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 to 3 weeks; often due to prolonged stress or anxiety caused by the death of a loved one, financial problems, etc

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

Causes of Insomnia

When an individual experiences insomnia, he or she may exhibit symptoms such as trouble falling asleep, difficulty staying asleep accompanied by episodes of frequent waking, and not feeling completely rested upon waking. Insomnia may be caused by a host of factors that can be classified as psychological, physical, and environmental. Common causes of insomnia can include3:

  • Stress or anxiety
  • Depression
  • Changes in environment, routine, or schedule
  • Certain medical conditions such as arthritis, congestive heart failure, gastric 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

Treating Insomnia

Insomnia can significantly impact a person's quality of life and ability to perform day-to-day routine tasks. Sleep-deprived individuals can experience symptoms such as irritability, difficulty in concentration, cognitive impairment, extreme fatigue, and anxiety. In order to determine the most appropriate treatment for a patient with insomnia, the clinician should evaluate the possible causes, duration, and severity of the symptoms of the insomnia.

Since the incidence of insomnia is prevalent, seeking information about the use of sleep aids is a common inquiry for many patients. Pharmacists are in a pivotal position to provide patients with information about insomnia and the proper selection of sleep aids. Pharmacists can be instrumental in screening for potential drug interactions and contraindications prior to the use of these sleep aids. Currently, there are several nonprescription products available that are indicated for the treatment of transient and short-term sleep disorders in patients who occasionally have problems with sleep (Table). Formulations available include single-entity antihistamine products containing diphenhydramine or doxylamine, as well as products formulated as antihistamine-analgesic combination products for those individuals whose insomnia is the result of uncontrolled pain. Complementary products include melatonin products, valerian, and a variety of homeopathic products.

The Role of the Pharmacist

Nonprescription sleep aids are indicated for short-term use and should be used only for 7 to 10 days unless otherwise directed by a physician. Pharmacists should refer patients with chronic insomnia for further medical evaluation. Prior to recommending any of these products, pharmacists should ascertain if the patient is an appropriate candidate for the use of nonprescription sleep aids. They should also ensure that patients thoroughly understand the proper use of these products and the potential adverse effects associated with their use. Pregnant women, breast-feeding women, and those with preexisting medical conditions should consult their primary health care providers. In addition, pharmacists can make recommendations for the implementation of nonpharmacologic measures to ensure a good night's rest and refer patients with chronic insomnia to seek medical evaluation when warranted. For more information on insomnia, visit the following Web sites: American Insomnia Association, www. americaninsomniaassociation.org; National Center on Sleep Disorders Research, NHLBI Health Information Center, www.nhlbi.nih.gov/sleep; National Sleep Foundation, www.sleepfoundation.org.

Oral Pain Treatments

A variety of nonprescription products are available for the self-treatment of the common conditions that are attributed to oral pain or discomfort (Table). Some of these conditions include toothache, tooth sensitivity, and teething in infants. Others involve oral mucosal disorders such as recurrent aphthous stomatitis (RAS), also called canker sores; herpes simplex labialis (HSL), which causes cold sores/fever blisters; and xerostomia, or dry mouth. Products include topical analgesics/anesthetics, toothpastes formulated for sensitive teeth, moisturizers for patients with dry mouth, oral mucosal protectants, and products that provide treatment and relief from cold sores.

The topical oral anesthetics present in nonprescription products include benzocaine (5% to 20%) and phenol (0.5%). At the present time, there are no products marketed for teething pain that contain 0.5% phenol. There are phenol-containing products for other types of oral pain, however.1 Most infant and children's teething products contain 7.5% benzocaine, but some nighttime formulas may contain 10% benzocaine. Topical analgesics are available in liquids and gels.

One of the newest products on the market is Orajel's Protective Mouth Sore Disc (Del Pharmaceuticals) that uses a bioadhesive technology, which involves a medicated disc that contains 15 mg of benzocaine. This disc forms a dissolvable bandage that enables an oral sore to heal while blocking further irritation, and can be used without interfering with eating or drinking.2

Recurrent Aphthous Stomatitis

Nonprescription products available for symptomatic relief of RAS include oral debriding and wound-cleansing products, topical oral anesthetics, topical oral protectants, and oral rinses. Cleansing and debriding agents contain carbamide peroxide (10% to 15%), hydrogen peroxide (3%), or sodium perborate monohydrate (1.2 g).1 These products can be used 4 times daily for no more than 7 days.

Herpes Simplex Labialis

The FDA has advised that the use of topical skin protectants and external topical analgesic/anesthetic products can provide symptomatic relief for individuals with HSL, but they will not reduce the duration of the HSL outbreak. Currently, docosanol 10% is the only FDA-approved nonprescription agent proven to reduce the duration and severity of an HSL outbreak.1 There are a myriad of products available to provide relief from the pain associated with an HSL outbreak, however.


To provide relief to individuals who experience xerostomia, there are saliva substitutes and mouth moisturizers that come in sprays, liquids, gels, mouthwashes, lozenges, and gums. Pharmacists can be instrumental in identifying patients who may be more susceptible to experiencing dry mouth, such as those taking certain medications (anticholinergic agents, antihypertensives, antihistamines, antidepressants), and patients with specific disease states (Sj?gren's syndrome, diabetes).1


The overall goals involved in the treatment of minor oral pain are to provide immediate symptomatic relief from discomfort and irritation and to promote healing. Patients should be assessed for appropriateness of therapy and educated on the proper use of these products. Patients should be advised to seek medical care if conditions show signs of worsening or infection.

Otic Products

It is essential that patients are thoroughly educated on the proper use of nonprescription products for the self-treatment of otic disorders such as excessive or impacted cerumen and water-clogged ears (Table). Nonprescription otic products should be used only for the treatment of external conditions which affect the auricle and the external ear canal.1 In addition, patients should be aware of those conditions where self-treatment is not appropriate and when they should seek immediate medical attention. Some exclusions for self-treatment of otic disorders include1:

  • Any signs of infection
  • Pain and drainage from the ear
  • Signs of bleeding or trauma
  • Recent ear surgery (within 6 weeks)
  • Any one <12 years of age
  • If tympanostomy tubes are present
  • If the tympanic membrane is ruptured

Excessive/Impacted Cerumen

Approximately 6% of the general population and 30% of the elderly population experiences episodes of impacted cerumen, and it is thought to be one of the most prevalent otic disorders.1 Individuals with excessive or impacted cerumen may experience a feeling of fullness or pressure in the ear and possibly a gradual loss of hearing. In addition, some may experience a dull sensation of pain. Carbamide peroxide 6.5% in anhydrous glycerin is the only FDA-approved nonprescription cerumen-softening agent for the softening and removal of excessive earwax in individuals 12 years of age and older. Cerumen-softening products can be used twice daily for up to 4 days. If symptoms persist after a 4-day period, patients should be referred to their primary care provider to seek further treatment.

Water-Clogged Ears

Due to the shape of an individual's ear canal, some patients may be more prone to an increased incidence of water-clogged ears. Excessive cerumen may also cause swelling, which in turn could trap water in the ear. Other factors that may precipitate water-clogged ears include excessive sweating, swimming, and humid climates.1 Patients may experience symptoms that can include a sensation of wetness and fullness in the ear. If left untreated, water-clogged ears may cause tissue maceration, which can manifest as both inflammation and infection of the external auditory canal, typically referred to as external otitis media or "swimmer's ear."1 Swimmer's ear is often accompanied by pain and itching as well. Isopropyl alcohol 95% in anhydrous glycerin 5% is the only FDA-approved "ear-drying" agent that has been proven to be safe and effective.1 Boric acid has been added to some products to increase acidity and acts as a weak germicide. These products are indicated for use in individuals 12 years of age and older.


Pharmacists should always ensure that patients are properly counseled on the appropriate use of otic products, especially since these products are limited to the treatment of minor disorders of the auricle and the external ear canal. Patients should monitor their condition for any signs of infection, such as ear discharge or hearing loss, and immediately seek medical attention if symptoms show signs of worsening or if they experience severe pain. Patients should also be counseled about the importance of proper ear hygiene, and they should not insert any objects into the ear to remove earwax so as not to cause injury to the ear canal. In addition, patients should always seek medical attention, when warranted, to avoid further complications.

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


Insomnia Treatments

1. Sleep Aids: All You Ever Wanted to Know...but Were Too Tired to Ask. National Sleep Foundation Web site. 2006. Available at: http://www.sleepfoundation.org/site/c.huIXKjM0IxF/b.2421197/k.2474/Sleep_Aids__ All_You_Ever_Wanted_to_Knowbut_Were_Too_Tired_to_Ask.htm.

2. Primary Insomnia. MedlinePlus Web site. 2006. Available at: www.nlm.nih.gov/medlineplus/ency/article/000805.htm.

3. Kirkwood C, Melton S. Insomnia. In: Berardi R, Kroon LA, McDermott JH, et al, eds. Handbook of Nonprescription Drugs. 15th ed. Washington, DC: American Pharmacists Association; 2006: 995-1008.

4. What Is Insomnia? National Heart, Lung, and Blood Institute Web site. 2006. Available at: www.nhlbi.nih.gov/health/dci/Diseases/inso/inso_all.html.

5. Types of Insomnia. Shuteye.com Web site. 2006. Available at: www.shuteye.com/insomnia_types.asp.

Oral Pain Treatments

1. Klasser G, Greene C. Oral Pain and Discomfort. In: Berardi R, Kroon LA, McDermott JH, et al, eds. Handbook of Nonprescription Drugs. 15th ed. Washington, DC: American Pharmacists Association; 2006: 678-708.

2. Orajel Products Web site. 2006. Available at: www.orajel.com.

Otic Products

1. Krypel L. Otic Disorders. In: Berardi R, Kroon LA, McDermott JH, et al, eds. Handbook of Nonprescription Drugs. 15th ed. Washington, DC: American Pharmacists Association; 2006: 633-678.