Current Landscape of Insomnia in Managed Care

Insomnia affects a large percentage of the population, particularly the elderly. Literature reports varying estimates of prevalence, a variation that relates to the lack of definition and consistency in diagnostic criteria. Primary insomnia (not caused by known physical/mental conditions) responds to pharmacologic therapy, while secondary insomnia(resulting from other illnesses, medications, or sleep disorders) responds to pharmacologic and psychologic treatments (cognitive therapy, relaxation techniques, stimulus control). Use of certain agents in the elderly and patients with abuse/addiction potential is a concern. Medicare Part D does not cover benzodiazepines (classified as controlled substances). Nonprescription agents are affordable but have sedation and anticholinergic side effects. Medication use should be considered a possible contributing factor. Insomnia patients experience significantly more limited activity and higher total health services than those without insomnia. Annual costs are between $92.5 billion and $107.5 billion. A standard definition and better pathways to recognize and treat insomnia are needed.

(Am J Manag Care. 2007;13:S112-S116)

Sleep constitutes nearly one third of a person's life, and many people are affected with difficulty in sleeping. Although there is wide variation in how insomnia is defined, it is clear that a number of Americans suffer from the condition. In general, insomnia consists of a complaint of disturbed sleep, which presents as difficulty in sleep initiation or maintenance, and/or early awakenings. Insomnia also includes the presence of daytime impairments to normal functioning as a result of sleep insufficiency. These impairments are generally manifested as fatigue, irritability, a decrease in memory and concentration, and malaise.^1,2 Given a lack of standardization for the term insomnia, and the infrequency of sleep problem assessment during patient histories, insomnia is often undiagnosed or untreated. Insomnia presents a challenge for managed care because it affects a large percentage of the population, particularly the elderly.

The objectives of this supplement are 4-fold: (1) to provide an overview of the current landscape of insomnia; (2) to summarize the pathophysiology and morbidity associated with the disorder; (3) to provide insight into the impact of insomnia on managed care, with a particular focus on the elderly; and (4) to explain the circadian rhythms and their relationship to treatment and outcomes in patients with insomnia.

Epidemiology

Chronic insomnia is generally associated with other disease states or conditions or is precipitated or aggravated by another disorder or substance. Examples of factors affecting sleep include conditions associated with chronic pain (eg, osteoarthritis, fibromyalgia), gastroesophageal reflux disease (GERD), heart failure, end-stage renal disease (ESRD), diabetes, neurologic problems, psychiatric disorders, and certain medications. For patients with osteoarthritis, Leigh et al found an insomnia prevalence of 31% to 81%, depending on the type of insomnia symptom being assessed.¹² Likewise, patients with rheumatoid arthritis, juvenile rheumatoid arthritis, and fibromyalgia have also reported episodes of insomnia.^4,13 Patients with GERD indicate problems with insomnia, particularly episodes of nocturnal awakening. The prevalence of insomnia has been reported to be as high as 80% in dialysis patients, and may be related to anemia associated with ESRD and dialysis. This association was proposed when patients treated for anemia experienced an improvement in sleep quality.¹⁴

Patients with type 1 and type 2 diabetes also appear to experience higher rates of insomnia. One theory postulates that alterations in circadian patterns of glucose metabolism may produce sleep problems. Such alterations have been noted in, and may underlie, the early-morning rise in plasma glucose levels. It is also plausible that insomnia in patients with diabetes may be related to comorbid obesity that results in breathing problems.⁴

A high prevalence of insomnia has also been observed in patients with neurologic disorders such as Parkinson's disease and Alzheimer's disease.^4,13 In patients with Parkinson's disease, insomnia is likely related to neurochemical changes in dopaminergic, serotonergic, and norepinephrine systems that interfere with the sleep-wake cycle. However, in some Parkinson's cases, insomnia may be attributed to medication use or to the dementia and depression that typically accompany the disease. Also, limb movements, bradykinesia, and rigidity that produce arousal during the night may contribute to insomnia in these patients.¹³

Insomnia has also been associated with psychiatric disorders; more than 40% of patients with persistent insomnia are reported to have a psychiatric disorder as well.^15,16 Depression is the psychiatric disorder most often associated with insomnia, although the relationship is complex. For some patients, insomnia may be a predictor for the onset of clinical depression.⁴ Patients typically complain of frequent awakenings and early-morning wakening. Some antidepressants (particularly the selective serotonin reuptake inhibitors) may contribute to insomnia in this population.¹³ Medication use (both prescription and over-the-counter [OTC]) has been reported to interfere with sleep patterns. Responses to medications are generally individualized, but should be considered as possible contributing factors when evaluating patients experiencing insomnia. Table 1 provides a list of medications associated with insomnia.¹³

Treatment of InsomniaInsomnia treatment should reflect the etiology of the patient's insomnia. Primary insomnia generally responds well to pharmacologic therapy, while secondary insomnia may be treated with pharmacologic and/or psychologic treatments. Treatment should be geared toward the specific component of insomnia that is most problematic for the patient (ie, sleep onset, sleep maintenance, sleep quality, or next-day functioning).¹⁷ Pharmacologic options can be grouped into 4 main categories: benzodiazepines, nonbenzodiazepines, melatonin receptor agonists, and OTC medications (Table 2). Currently, 5 benzodiazepines are approved for use in the United States for the short-term treatment of insomnia. However, use of these agents in certain populations, most notably the elderly and patients with a potential for abuse or addiction, is a concern. Moreover, Medicare Part D does not cover the use of benzodiazepines. The nonbenzodiazepine agents provide an alternative to benzodiazepines in the treatment of insomnia. However, a majority of the nonbenzodiazepine agents have a mechanism of action similar to the benzodiazepines in that both bind to a gamma-aminobutyric acid receptor. The exception to this mechanism is ramelteon, which is a selective agonist for the melatonin MT1/MT2 receptors. Ramelteon has a reported advantage of no abuse potential compared with the benzodiazepines which are classified as C-IV controlled substances.

Several OTC preparations are also available for insomnia treatment. These medications consist largely of antihistamines that are marketed as sleep aids because of their sedative side effects. These nonprescription agents have the advantage of being relatively inexpensive but are often associated with next-day sedation, anticholinergic side effects (dry mouth, blurred vision), and tolerance. Psychologic treatments for insomnia are also a consideration, particularly for patients suffering from secondary insomnia. Psychologic approaches to treatment include cognitive therapy, cognitive behavioral therapy, relaxation techniques, sleep restriction, and stimulus control.^13,18

Implications and Recommendations

Insomnia affects a substantial proportion of the US population and has clinical, economic, and humanistic consequences for the patient and society. A standard and generally recognized definition of insomnia, as well as better pathways to recognize and treat insomnia and its underlying comorbidities are needed. Pharmacologic and psychologic treatments for insomnia are available and should be used to treat specific components of insomnia. The clinical and economic effects of insomnia are substantial, with insomnia resulting in decreased QOL and increased healthcare utilization, particularly in the elderly. The remainder of this supplement focuses on the pathophysiology and morbidity of insomnia, the impact of insomnia and its treatment on managed care organizations, and the circadian rhythm as it relates to insomnia.

Address correspondence to: Thomas J. Bramley, PhD, Senior Director, Xcenda, 1528 Preston Street, Salt Lake City, UT 84108. E-mail: tommy.bramley@xcenda.com.1. Doghramji K. The epidemiology and diagnosis of insomnia. Am J Manag Care. 2006;12(8 suppl):S214-S220.

3. Roth T, Roehrs T. Insomnia: epidemiology, characteristics, and consequences. Clin Cornerstone. 2003;5:5-15.

S221-S229.

6. Goldberg LD. Managing insomnia in an evolving marketplace. Am J Manag Care. 2006;12(8 suppl):S212-S213.

8. Katz DA, McHorney CA. Clinical correlates of insomnia in patients with chronic illness. Arch Intern Med. 1998;158:1099-1107.

10. Foley DJ, Monjan AA, Brown SL, Simonsick EM, Wallace RB, Blazer DG. Sleep complaints among elderly persons: an epidemiologic study of three communities. Sleep. 1995;18:425-432.

12. Leigh TJ, Hindmarch I, Bird HA,Wright V. Comparison of sleep in osteoarthritic patients and age and sex matched healthy controls. Ann Rheum Dis. 1988;47:40-42.

14. Benz RL, Pressman MR, Hovick ET, Peterson DD. A preliminary study of the effects of correction of anemia with recombinant human erythropoietin therapy on sleep, sleep disorders, and daytime sleepiness in hemodialysis patients (the SLEEPO study). Am J Kidney Dis. 1999;34:1089-1095.

16. McCall WV. A psychiatric perspective on insomnia. J Clin Psychiatry. 2001;62(suppl 10):27-32.

18. Stepanski EJ, Rybarczyk B. Emerging research on the treatment and etiology of secondary or comorbid insomnia. Sleep Med Rev. 2006;10:7-18.

20. Zammit GK, Weinger J, Damato N, Sillup GP, McMillan CA. Quality of life in people with insomnia. Sleep. 1999;22(suppl 2):S379-S385.

22. Stoller MK. Economic effects of insomnia. Clin Ther. 1994;16:873-897; discussion 854.

24. Chesson A Jr, Hartse K, Anderson WM, et al. Practice parameters for the evaluation of chronic insomnia. An American Academy of Sleep Medicine report. Standards of Practice Committee of the American Academy of Sleep Medicine. Sleep. 2000;23:237-241.

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