Approximately 75% of Americans report at least one symptom associated with insomnia throughout the year.
Ms. Terrie is a clinical pharmacy writer based in Haymarket, Virginia.
Insomnia can negatively impact one'squality of life and impair an individual'sability to perform day-to-day tasks.According to results from a 2005 surveyby the National Sleep Foundation, anestimated 75% of adults in the UnitedStates report one or more symptomsassociated with insomnia during theyear.1,2 In addition, more than 33% of allindividuals in the United States experienceinsomnia almost every night.1Insomnia is a common complaint amongthe elderly, affecting an estimated 25%of this patient population and about 10%of the general population.1,3
Types of Insomnia
Insomnia can be classified as 2 differenttypes: primary or secondary. Primaryinsomnia typically lasts for 1 month ormore and is not directly the result ofanother sleep disorder, general medicalcondition, psychiatric disorder, orthe use of any pharmacologic agent.1,3
Secondary insomnia is the most prevalentform of insomnia, accounting for 8of every 10 individuals who experienceinsomnia.1,3,4 It is the result of anotheridentifiable underlying source, such ascertain medical conditions or the use ofpharmacologic agents.1,3,4Insomnia can be further categorizedbased on the duration and severity ofthe episodes as follows1,4:
- Transient: self-limiting and lasting<1 week; often caused by temporarystress, anxiety, or schedulechanges.
- Acute or short term: lasting 1 to3 weeks; often due to prolongedstress or anxiety caused by thedeath of a loved one, financial problems,etc.
- Chronic: lasting more than 3weeks; often the result of medicalconditions, mental disorders, orsubstance abuse.
Symptoms and Causes
Common insomnia symptoms includedifficulty falling asleep, trouble stayingasleep, accompanied by episodes ofrepeated awakenings, and not feelingfully rested upon waking. Insomnia maybe caused by a host of factors that can beclassified as psychological, physical, andenvironmental.1 Examples of factors thatmay contribute to an increased incidenceof insomnia include the use of alcohol,nicotine, and caffeine; depression; stress;anxiety; changes in one's environment,routine, or schedule; certain medicalconditions (eg, arthritis, congestive heartfailure, gastric reflux disease, respiratorydisorders, headaches, chronic paindisorders, and psychiatric disorders);and the use of certain medications (eg,antidepressants, antihypertensives, andsympathomimetic amines).1
Individuals experiencing insomniaalso may experience one or more of thefollowing symptoms: irritability, difficultyconcentrating, cognitive impairment,extreme fatigue, and anxiety.1,4
A variety of OTC products are currentlyavailable for the managementand treatment of transient and shortterminsomnia in individuals who experienceoccasional episodes of difficultysleeping (Table). The products includesingle-entity antihistamines containingdiphenhydramine or doxylamine. Themost common active ingredient foundin OTC sleep aids is diphenhydramine.Diphenhydramine should be avoided inindividuals older than 65 years of agedue to an increased risk of anticholinergicadverse effects.1 These productsalso should not be used with alcohol dueto the additive central nervous system?depressant effects of alcohol.1 Commonadverse effects associated with the useof diphenhydramine include morninggrogginess, dry mouth, urinary retention,constipation, and blurred vision.1
Additional products include antihistamine?analgesic combination productsfor those individuals whose insomnia isthe result of uncontrolled pain, as wellas complementary products, such asmelatonin and valerian products and avariety of homeopathic products.
In general, the use of these nonprescriptionsleep aids are indicated forshort-term use and should only be usedfor 7 to 10 days unless otherwise directedby a physician.1 Patients should beadvised to contact their primary healthcare provider if they see no sign ofimprovement or if symptoms worsenafter 10 days of self-treatment.1
For more information on insomnia, visit:
? American Insomnia Association:
? National Center on Sleep Disorders Research:
? National Sleep Foundation:
Prior to recommending any of theseproducts, pharmacists should ascertainthe appropriateness of these productsand screen for possible drug interactionsand contraindications. Patientselecting to use these products should bethoroughly counseled on their properuse and potential adverse effects andshould be advised not to use them inconjunction with prescription sleepaids. Patients using allergy and/or coughand cold medications also should bereminded to check active ingredientsbefore taking these medications toavoid possible therapeutic duplications.Pregnant or lactating women, childrenyounger than 12 years of age, and thosewith preexisting medical conditionsshould consult their primary health careprovider prior to using any of theseproducts.1 In addition, pharmacists canmake recommendations of various nonpharmacologicmeasures that may alsoprovide patients with a restful night ofsleep. It is important to advise patientswith chronic insomnia to seek medicalevaluation when warranted.
Examples of OTC Products Marketed for Insomnia
Single-Entity Antihistamine Sleep Aid Products (contain diphenhydramine)
- Tylenol Simply Sleep (25 mg)
- Nytol Nighttime Sleep-Aid Caplets (25 mg)
- Sleepinal Maximum Strength Night-time Sleep Aid Capsules (50 mg)
- Sominex Original Formula Tablets (25 mg)
- Sominex Maximum Strength Night-time Sleep Aid Caplets (50 mg)
- Unisom SleepTabs Nighttime Sleep-Aid Tablets (25 mg)
- Unisom Maximum Strength SleepGels Nighttime Sleep-Aid Softgels (50 mg)
- Unisom SleepMelts Tablets (25 mg)
Contains Doxylamine Succinate 25 mg
- Unisom SleepTabs Nighttime Sleep-Aid Tablets
Antihistamine?Analgesic Combination Products
- Advil PM (ibuprofen 200 mg, diphenhydramine citrate 38 mg)
- Alka Seltzer PM (aspirin 325 mg, diphenhydramine citrate 38 mg)
- Bayer PM (aspirin 500 mg, diphenhydramine citrate 38.3 mg)
- Excedrin PM (acetaminophen 500 mg, diphenhydramine citrate 38 mg)
- Goody's PM Powder (acetaminophen 1000 mg, diphenhydramine citrate 76 mg per 2 powder dose)
- Legatrin PM Advanced Formula Pain Reliever/Sleep Aid Caplets (acetaminophen 500 mg, diphenhydramine HCl 50 mg)
- Tylenol PM (acetaminophen 500 mg, diphenhydramine HCl 25 mg)
- Nature Made Melatonin 3-mg Tablets
- Natrol Melatonin 5-mg Tablets
- Nature's Bounty Maximum Strength Melatonin 5-mg Tablets
- Nature's Way Valerian Nighttime, Natural Sleep Aid Tablets
- Nature Made Valerian Capsules
- Alluna Sleep Herbal Supplement
- Hyland's Calms Forte Non?Habit-Forming Sleep Aid Tablets
- Hyland's Calms Forte 4 Kids Sleep Aid
- Boiron Quietude, for Sleeplessness and Restless Sleep
- Sleep MD Tablets
Nonpharmacologic Measures to Aid in Insomnia Treatment
Single-Entity Antihistamine Sleep Aid Products (contain diphenhydramine)
- If possible, go to bed at the same time each day
- Avoid eating heavy meals within 2 hours of bedtime
- Create an environment conducive to sleep by minimizing light and noise
- Practice relaxation techniques prior to retiring for the evening
- Avoid the use of any caffeine, nicotine, or alcohol at least 4-6 hours before bedtime
- If possible, avoid napping during the day
- Do not exercise within 2-4 hours of bedtime
Adapted from reference 1.
- Kirkwood C, Melton S. Insomnia. In: Berardi RR, Kroon LA, McDermott JH, et al, eds. Handbook of Nonprescription Drugs. 15th ed. Washington, DC: American Pharmacists Association; 2006: 995-1008.
- 2005 Sleep in America Poll, Summary of Findings. National Sleep Foundation Web site. www.kintera.org/atf/cf/%7BF6BF2668-A1B4-4FE8-8D1A-A5D39340D9CB%7D/2005_summary_of_findings.pdf. Accessed December 8, 2008.
- Primary Insomnia. Medline Plus Web site. www.nlm.nih.gov/medlineplus/ency/article/000805.htm. Accessed December 7, 2008.
- What is Insomnia? National Heart, Lung, and Blood Institute Web site. www.nhlbi.nih.gov/health/dci/Diseases/inso/inso_whatis.html. Accessed December 7, 2008.