A Pharmacist's Guide to OTC Therapy

Insomnia Treatments

A survey conducted by the NationalSleep Foundation reported that ~48%of people in the United States haveoccasionally experienced one or moreof the symptoms associated withinsomnia, while about 22% experienceinsomnia nightly or almost every night.¹Furthermore, the incidence of insomniais 1.5 times greater in individuals overthe age of 65, when compared withyounger individuals, and is more prevalentamong women than men.¹

Types of Insomnia

The 2 types of insomnia are primaryand secondary insomnia. Primaryinsomnia typically lasts for 1 month ormore and isnot directly theresult of anothersleep disorder,generalmedical condition,or psychiatricdisorder,or due to the useof any pharmacologicagent.^2,3 Secondary insomnia is themost prevalent form, accounting for 8of every 10 patients who experienceinsomnia. It is the result of another,identifiable underlying source, such ascertain medical conditions or pharmacologicagents.^2,4

Insomnia can be further categorizedbased upon the duration and severityof the episodes as follows^3,5:

1. Transient?self-limiting and lastingless than 1 week; often causedby temporary stress, anxiety, orschedule changes

2. Acute or Short-term?lasting 1to 3 weeks; often due to prolongedstress or anxiety caused bythe death of a loved one, financialproblems, etc

3. Chronic?lasting more than 3weeks; often the result of medicalconditions, mental disorders, orsubstance abuse

Causes of Insomnia

When an individual experiences insomnia,he or she may exhibit symptomssuch as trouble falling asleep, difficultystaying asleep accompanied byepisodes of frequent waking, and notfeeling completely rested upon waking.Insomnia may be caused by a host offactors that can be classified as psychological,physical,and environmental. Commoncauses of insomniacan include³:

• Stress or anxiety
• Depression
• Changes in environment,routine,or schedule
• Certain medical conditionssuch as arthritis,congestiveheart failure, gastricreflux disease,respiratory disorders,and psychiatricdisorders
• Use of certain pharmacologicagentssuch as antidepressants,antihypertensives,andsympathomimeticamines
• Use of caffeine, nicotine,and alcohol

Treating Insomnia

Insomnia can significantly impact aperson's quality of life and ability toperform day-to-day routine tasks.Sleep-deprived individuals can experiencesymptoms such as irritability, difficultyin concentration, cognitive impairment,extreme fatigue, and anxiety.In order to determine the most appropriatetreatment for a patient with insomnia,the clinician should evaluatethe possible causes, duration, andseverity of the symptoms of the insomnia.

Since the incidence of insomnia isprevalent, seeking information aboutthe use of sleep aids is a commoninquiry for many patients. Pharmacistsare in a pivotal position to providepatients with information about insomnia and the proper selection of sleepaids. Pharmacists can be instrumentalin screening for potential drug interactionsand contraindications prior to theuse of these sleep aids. Currently, thereare several nonprescription productsavailable that are indicated for the treatmentof transient and short-term sleepdisorders in patients who occasionallyhave problems with sleep (Table).Formulations available include single-entityantihistamine products containingdiphenhydramine or doxylamine, aswell as products formulated as antihistamine-analgesic combination productsfor those individuals whose insomniais the result of uncontrolledpain. Complementary products includemelatonin products, valerian, and avariety of homeopathic products.

The Role of the Pharmacist

Nonprescription sleep aids are indicatedfor short-term use and should beused only for 7 to 10 days unless otherwisedirected by a physician. Pharmacistsshould refer patients withchronic insomnia for further medicalevaluation. Prior to recommending anyof these products, pharmacists shouldascertain if the patient is an appropriatecandidate for the use of nonprescriptionsleep aids. They should alsoensure that patients thoroughly understandthe proper use of these productsand the potential adverse effects associatedwith their use. Pregnant women,breast-feeding women, and those withpreexisting medical conditions shouldconsult their primary health care providers.In addition, pharmacists canmake recommendations for the implementationof nonpharmacologic measuresto ensure a good night's rest andrefer patients with chronic insomnia toseek medical evaluation when warranted.For more information on insomnia,visit the following Web sites:American Insomnia Association, www.americaninsomniaassociation.org; NationalCenter on Sleep Disorders Research,NHLBI Health Information Center,www.nhlbi.nih.gov/sleep; National SleepFoundation, www.sleepfoundation.org.

Oral Pain Treatments

A variety of nonprescription productsare available for the self-treatment of thecommon conditions that are attributed tooral pain or discomfort (Table). Some ofthese conditions include toothache, toothsensitivity, and teething in infants. Othersinvolve oral mucosal disorders such asrecurrent aphthous stomatitis (RAS), alsocalled canker sores; herpes simplex labialis(HSL), which causes cold sores/feverblisters; and xerostomia, or dry mouth.Products include topical analgesics/anesthetics,toothpastes formulated for sensitiveteeth, moisturizers for patients withdry mouth, oral mucosal protectants, andproducts that provide treatment andrelief from cold sores.

The topical oral anesthetics presentin nonprescription products includebenzocaine (5% to 20%) and phenol(0.5%). At the present time, there areno products marketed for teething painthat contain 0.5% phenol. There arephenol-containing products for othertypes of oral pain, however.¹ Mostinfant and children's teething productscontain 7.5% benzocaine, but somenighttime formulas may contain 10%benzocaine. Topical analgesics areavailable in liquids and gels.

One of the newest products on themarket is Orajel's Protective MouthSore Disc (Del Pharmaceuticals) thatuses a bioadhesive technology, whichinvolves a medicated disc that contains15 mg of benzocaine. This disc forms adissolvable bandage that enables anoral sore to heal while blocking furtherirritation, and can be used withoutinterfering with eating or drinking.²

Recurrent Aphthous Stomatitis

Nonprescription products availablefor symptomatic relief of RAS includeoral debriding and wound-cleansingproducts, topical oral anesthetics, topicaloral protectants, and oral rinses.Cleansing and debriding agents containcarbamide peroxide (10% to 15%),hydrogen peroxide (3%), or sodiumperborate monohydrate (1.2 g).¹ Theseproducts can be used 4 times daily forno more than 7 days.

Herpes Simplex Labialis

The FDA has advised that the use oftopical skin protectants and externaltopical analgesic/anesthetic productscan provide symptomatic relief for individualswith HSL, but they will notreduce the duration of the HSL outbreak.Currently, docosanol 10% is theonly FDA-approved nonprescriptionagent proven to reduce the durationand severity of an HSL outbreak.¹ Thereare a myriad of products available toprovide relief from the pain associatedwith an HSL outbreak, however.

Xerostomia

To provide relief to individuals whoexperience xerostomia, there are salivasubstitutes and mouth moisturizersthat come in sprays, liquids, gels,mouthwashes, lozenges, and gums.Pharmacists can be instrumental inidentifying patientswho maybe more susceptibleto experiencingdrymouth, such asthose taking certainmedications(anticholinergicagents, antihypertensives,antihistamines,antidepressants),and patients withspecific diseasestates (Sj?gren's syndrome, diabetes).¹

Conclusion

The overall goals involved in the treatmentof minor oral pain are to provideimmediate symptomatic relief from discomfortand irritation and to promotehealing. Patients should be assessed forappropriateness of therapy and educatedon the proper use of these products.Patients should be advised to seek medicalcare if conditions show signs ofworsening or infection.

Otic Products

It is essential that patients are thoroughlyeducated on the proper use ofnonprescription products for the self-treatmentof otic disorders such asexcessive or impacted cerumen andwater-clogged ears (Table).Nonprescription otic productsshould be used only forthe treatment of externalconditions which affect theauricle and the external earcanal.¹ In addition, patientsshould be aware of thoseconditions where self-treatmentis not appropriate andwhen they should seekimmediate medical attention.Some exclusions for self-treatmentof otic disordersinclude¹:

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

Excessive/Impacted Cerumen

Approximately 6% of the generalpopulation and 30% of the elderly populationexperiences episodes ofimpacted cerumen, and it is thought tobe one of the most prevalent otic disorders.¹ Individuals with excessive orimpacted cerumen may experience afeeling of fullness or pressure in theear and possibly a gradual loss of hearing.In addition, some may experiencea dull sensation of pain. Carbamideperoxide 6.5% in anhydrous glycerin isthe only FDA-approved nonprescriptioncerumen-softening agent for thesoftening and removal of excessiveearwax in individuals 12 years of ageand older. Cerumen-softening productscan be used twice daily for up to 4days. If symptoms persist after a 4-dayperiod, patients should be referred totheir primary care provider to seek furthertreatment.

Water-Clogged Ears

Due to the shape of an individual's earcanal, some patients may be moreprone to an increased incidence ofwater-clogged ears. Excessive cerumenmay also cause swelling, which in turncould trap water in the ear. Other factorsthat may precipitate water-clogged earsinclude excessive sweating, swimming,and humid climates.¹ Patients may experiencesymptoms that can include a sensationof wetness and fullness in the ear.If left untreated, water-clogged ears maycause tissue maceration, which canmanifest as both inflammation andinfection of the external auditory canal,typically referred to as external otitismedia or "swimmer's ear."¹ Swimmer'sear is often accompanied by pain anditching as well. Isopropyl alcohol 95% inanhydrous glycerin 5% is the only FDA-approved"ear-drying" agent that hasbeen proven to be safe and effective.¹Boric acid has been added to someproducts to increase acidity and acts asa weak germicide. These products areindicated for use in individuals 12 yearsof age and older.

Conclusion

Pharmacists should always ensurethat patients are properly counseledon the appropriate use of otic products,especially since these productsare limited to the treatment of minordisorders of the auricle and the externalear canal. Patients should monitortheir condition for any signs of infection,such as ear discharge or hearingloss, and immediately seek medicalattention if symptoms show signs ofworsening or if they experience severepain. Patients should also be counseledabout the importance of proper earhygiene, and they should not insert anyobjects into the ear to remove earwaxso as not to cause injury to the earcanal. In addition, patients shouldalways seek medical attention, whenwarranted, to avoid further complications.

Ms. Terrie is a clinical pharmacy writerbased in Haymarket, Va.

References

Insomnia Treatments

1. Sleep Aids: All You Ever Wanted to Know...but Were Too Tired to Ask. National SleepFoundation 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 PharmacistsAssociation; 2006: 995-1008.

4. What Is Insomnia? National Heart, Lung, and Blood Institute Web site. 2006. Availableat: 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 ofNonprescription 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 NonprescriptionDrugs. 15th ed. Washington, DC: American Pharmacists Association; 2006: 633-678.