Treating Insomnia

FEBRUARY 01, 2009
Yvette C. Terrie, BSPharm, RPh

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

Insomnia can negatively impact one's quality of life and impair an individual's ability to perform day-to-day tasks. According to results from a 2005 survey by the National Sleep Foundation, an estimated 75% of adults in the United States report one or more symptoms associated with insomnia during the year.1,2 In addition, more than 33% of all individuals in the United States experience insomnia almost every night.1 Insomnia is a common complaint among the 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 different types: primary or 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 the use of any pharmacologic agent.1,3

Secondary insomnia is the most prevalent form of insomnia, accounting for 8 of every 10 individuals who experience insomnia.1,3,4 It is the result of another identifiable underlying source, such as certain medical conditions or the use of pharmacologic agents.1,3,4 Insomnia can be further categorized based on the duration and severity of the episodes as follows1,4:

  1. Transient: self-limiting and lasting <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.

Symptoms and Causes

Common insomnia symptoms include difficulty falling asleep, trouble staying asleep, accompanied by episodes of repeated awakenings, and not feeling fully rested upon waking. Insomnia may be caused by a host of factors that can be classified as psychological, physical, and environmental.1 Examples of factors that may contribute to an increased incidence of insomnia include the use of alcohol, nicotine, and caffeine; depression; stress; anxiety; changes in one's environment, routine, or schedule; certain medical conditions (eg, arthritis, congestive heart failure, gastric reflux disease, respiratory disorders, headaches, chronic pain disorders, and psychiatric disorders); and the use of certain medications (eg, antidepressants, antihypertensives, and sympathomimetic amines).1

Individuals experiencing insomnia also may experience one or more of the following symptoms: irritability, difficulty concentrating, cognitive impairment, extreme fatigue, and anxiety.1,4

Treating Insomnia

A variety of OTC products are currently available for the management and treatment of transient and shortterm insomnia in individuals who experience occasional episodes of difficulty sleeping (Table). The products include single-entity antihistamines containing diphenhydramine or doxylamine. The most common active ingredient found in OTC sleep aids is diphenhydramine. Diphenhydramine should be avoided in individuals older than 65 years of age due to an increased risk of anticholinergic adverse effects.1 These products also should not be used with alcohol due to the additive central nervous system?depressant effects of alcohol.1 Common adverse effects associated with the use of diphenhydramine include morning grogginess, dry mouth, urinary retention, constipation, and blurred vision.1

Additional products include antihistamine?analgesic combination products for those individuals whose insomnia is the result of uncontrolled pain, as well as complementary products, such as melatonin and valerian products and a variety of homeopathic products.

In general, the use of these nonprescription sleep aids are indicated for short-term use and should only be used for 7 to 10 days unless otherwise directed by a physician.1 Patients should be advised to contact their primary health care provider if they see no sign of improvement or if symptoms worsen after 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 these products, pharmacists should ascertain the appropriateness of these products and screen for possible drug interactions and contraindications. Patients electing to use these products should be thoroughly counseled on their proper use and potential adverse effects and should be advised not to use them in conjunction with prescription sleep aids. Patients using allergy and/or cough and cold medications also should be reminded to check active ingredients before taking these medications to avoid possible therapeutic duplications. Pregnant or lactating women, children younger than 12 years of age, and those with preexisting medical conditions should consult their primary health care provider prior to using any of these products.1 In addition, pharmacists can make recommendations of various nonpharmacologic measures that may also provide patients with a restful night of sleep. It is important to advise patients with chronic insomnia to seek medical evaluation 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)

Melatonin-Containing Products

  • Nature Made Melatonin 3-mg Tablets
  • Natrol Melatonin 5-mg Tablets
  • Nature's Bounty Maximum Strength Melatonin 5-mg Tablets

Valerian-Containing Products

  • 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

Table Insomnia
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.


  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.
  2. 2005 Sleep in America Poll, Summary of Findings. National Sleep Foundation Web site. Accessed December 8, 2008.
  3. Primary Insomnia. Medline Plus Web site. Accessed December 7, 2008.
  4. What is Insomnia? National Heart, Lung, and Blood Institute Web site. Accessed December 7, 2008.