The State of Insomnia and Emerging Trends

Thomas Roth, PhD

Meg Franklin, PharmD, PhD

Thomas J. Bramley, PhD

Supplements and Featured Publications, Management and Treatment of Insomnia and Its Impact on Today’s Managed Care, Volume 13, Issue 5 Suppl

Recent research into the pathophysiology of insomnia has brought a shift in the approach to treatment. Insomnia rarely occurs in isolation and is typically comorbid with other conditions. Rather than simply treating the primary disorder, whereby symptoms of insomnia may go unaddressed, now there is a push to acknowledge the existence of chronic insomnia as a disorder that itself merits treatment. This recognition is due to the identification of pathophysiologic changes and associated morbidity, which can be substantial. Insomnia patients have increased risk for psychiatric disorders, especially depression, anxiety, decreased quality of life, increased healthcare utilization and costs, drug/alcohol abuse, decreased occupational performance, and increased falls/accidents. Current management patterns explore non-nightly or discontinuous hypnotic treatment—non-nightly flexible, non-nightly semiflexible, non-nightly fixed, and flexible timing—which deviates from past trends of continuous dosing with hypnotics. These trends reflect a change from considering insomnia a symptom to treating insomnia as a disorder.

(Am J Manag Care. 2007;13:S117-S120)

Recent research into the pathophysiology of chronic insomnia has brought about a shift in the management of insomnia. The National Institutes of Health issued a statement in 2005 regarding the nature and management of chronic insomnia based on the findings of an independent panel of sleep experts. The panel weighed all evidence available to date on insomnia and prepared a State-of-the-Science Conference Statement, the first consensus statement to be issued on insomnia since 1983. The consensus statement reflects the evolving trend of considering insomnia as a disorder and not merely a symptom, as was the accepted view in the 1980s. Also, insomnia rarely occurs in isolation, but rather is typically comorbid with other conditions. The 2005 statement also reflects the change in approach to treatment. Rather than simply treating the primary disorder, whereby symptoms of insomnia may go unaddressed, now there is a push to acknowledge the existence of chronic insomnia as a disorder that itself merits treatment. Substantiation that insomnia is a disorder is based on data that insomnia is associated with pathophysiologic changes and results in morbidity, as is evidenced by impairment in function and quality of life (QOL).1

Insomnia encompasses 1 or more of the following: difficulty initiating sleep; difficulty maintaining sleep; waking up too early; and/or sleep that is chronically nonrestorative or of poor quality.2 The determining factor in relating these symptoms to insomnia is that the sleep difficulty occurs despite adequate opportunity and circumstances for sleep. In addition to the reported difficulties with sleep, the diagnosis of insomnia also includes reports of daytime impairment or distress related to the nighttime sleep difficulty. These impairments may include, but are not limited to, problems such as fatigue, memory impairment, mood disturbances, proneness for errors, tension headaches, and gastrointestinal symptoms in response to sleep loss.3 The recognition of insomnia as a disorder is due to the identification of pathophysiologic changes and morbidity associated with it. This article will discuss the pathophysiology and the morbidity associated with insomnia and provide insight into the emerging trends for the management of insomnia.

Pathophysiology of Insomnia

The effects of insomnia on patients can result in a substantial amount of morbidity for those suffering from insomnia. Patients with insomnia have a demonstrated increased risk for psychiatric disorders especially depression, decreased QOL, increased healthcare utilization and costs, absenteeism and decreased occupational performance, and an increase in falls and/or accidents. An association between insomnia and psychiatric

likelihood of MDD given a patient has insomnia. Effects of insomnia on QOL have proven difficult to measure. Health-related QOL (HRQOL) is defined as the “overall state of well-being that individuals experience as assessed by subjective and objective measures of functioning, health, and satisfaction with the important dimensions of their lives.”15 Measuring HRQOL in patients with insomnia is problematic due to the unstandardized morbidity measures surrounding the disorder. Several questionnaires and/or measurement tools do exist that provide information regarding insomnia and other sleep disorders.15 Work done in the area of insomnia and HRQOL has found insomnia to be independently associated with HRQOL across multiple domains, including mental health, vitality, and general health perceptions, as documented in a study by Katz and McHorney.16 The study also determined that HRQOL in patients with insomnia was worsened to almost the same extent as HRQOL in patients with chronic conditions such as congestive heart failure and depression. A study conducted by Hatoum et al surveyed patients across 5 managed care organizations on HRQOL.17 Results showed patients with insomnia had lower HRQOL scores based on the 36-Item Short Form Health Survey (SF-36) measurement tool. Insomnia was consistently significantly associated with worsened outcomes across all domains of the SF-36 measurement tool.

In addition to worsened HRQOL, patients with insomnia have historically experienced increased healthcare utilization compared with patients who did not suffer from insomnia. Healthcare utilization encompassed prescription and nonprescription medications, physician visits and calls, laboratory work, emergency department visits, and hospitalizations. The study by Hatoum et al concluded that the severity of insomnia played a role, as patients with more severe cases of insomnia (classified as Level II) reported higher healthcare utilization than Level I insomnia patients.17 An analysis of pharmacy and medical claims data by Ozminkowski et al found average direct and indirect costs for younger adults to be approximately $1200 higher per insomnia patient when evaluating costs in the 6 months before the onset of insomnia compared with 6 months of costs in matched patients without insomnia.18 Analysis of direct costs in elderly patients with insomnia yielded costs approximately $1100 higher per patient than those patients without insomnia.

Further contributing to the indirect costs of insomnia is its effect on productivity, particularly in the workplace. Insomnia negatively affects work productivity, as absenteeism is associated with insomnia. Insomnia patients averaged 15.8 days absent from work per year compared with 1.6 days absent in a control group in a study conducted by Zammit et al.19 Similarly, patients with a sleep problem had a higher percentage rate of missing work than patients with no sleep problem.20 The morbidity of insomnia can be substantial, affecting all aspects of a patient's life. Recognizing the effects of insomnia is essential for the treatment and management of chronic insomnia.

Emerging Trends in Insomnia Management

focused on benzodiazepine receptor agonists. Current management patterns are exploring the effectiveness of non-nightly or discontinuous hypnotic treatment. This approach to treatment may offer the benefits of relief from insomnia while preventing the nightly use of medications.21 Strategies for non-nightly dosing include non-nightly flexible, non-nightly semiflexible, non-nightly fixed, and flexible timing. Non-nightly flexible dosing allows patients to treat themselves on an as-needed basis, with the medication only taken on nights when symptoms occur. This can range from a few nights per month to nightly, depending on patients' needs. Non-nightly semiflexible dosing is recommended as a prospective action, when a patient anticipates experiencing a bad night. This type of dosing is recommended for a limited number of nights per week. Non-nightly fixed dosing

levels, normal sleep patterns may be restored by decreasing nocturnal levels of CRF. Further exploration is warranted into the use of antiglucocorticoid agents for possible treatment of insomnia.


Address correspondence to: Thomas J. Bramley, PhD, Senior Director, Xcenda, 1528

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17. Hatoum HT, Kong SX, Kania CM, Wong JM, Mendelson WB. Insomnia, health-related quality of life and healthcare resource consumption. A study of managed-care organisation enrollees. Pharmacoeconomics. 1998;14:629-637.

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

21. Hajak G. New paradigms in the pharmacological treatment of insomnia. Sleep Med. 2006;7(suppl 1):S20-S36.