Successful Treatment of Insomnia Starts With Formulary Design

Many insurers may not consider insomnia a serious health problem, but it costs employers a bundle in lowered productivity

Inadequate identification and treatment of insomnia has serious medical and public health implications, resulting in impaired productivity, diminished quality of life, and potentially life-threatening comorbidities. According to several studies, including a review this year by the Institute of Medicine, pharmacological approaches to treating insomnia are cost effective, but not widely understood or sufficiently employed by physicians or health plans.

“Poor sleep is associated with a perceived decrease in quality of life, an increase in physical complaints, and economic repercussions including decreased productivity,” says Michael J. Sateia, MD, of the Sleep Disorders Center at the Dartmouth-Hitchcock Medical Center. “And there may be dangerous and expensive consequences in the form of accidents.”

Insomnia can present as either a primary condition or secondary to an associated set of medical or psychological problems. Once diagnosed the disorder is classified as transient, intermittent, or chronic. Transient and intermittent insomnia are often related to stress and environment changes and may be partially resolved by modification of sleep habits or utilization of over-the-counter products, such as antihistamines, according to AASM guidelines. Chronic insomnia, however, is complex and caused by a combination of factors. Perhaps there is a severe mental or physical disorder such as depression, Parkinson’s disease, or arthritis. Chronic insomnia requires physician and pharmacist intervention for adequate treatment, and support from health plans in guidelines and payment practices.

Insomnia is associated with high health care utilization. Sufferers have more ongoing medical problems. The condition is associated with a two-fold increase in hospitalizations and physician visits. It is also a risk factor for psychiatric disorders, such as depression, across all demographic groups and is a significant symptom and causal agent for a range of major and comparatively minor medical problems, including obesity and falls.

All this leads to billions of dollars in costs. The annual direct medical cost for insomnia is about $17 billion for health care services in 2006 dollars. The indirect cost of insomnia, related to lost productivity associated with absenteeism and presenteeism (the condition of being present at work but functioning at an impaired level) is estimated to be $109 billion annually in 2006 dollars.

Health plans’ role

The economic burden and physiological roots of insomnia imply that a progressive medical approach could reduce overall health costs, but this common and destructive disorder is generally considered a subjective, self-diagnosed condition by both physicians and patients.

As a result, health plans have tended to view it as a limited clinical problem. Many health plans do not include pharmaceutical sleep agents in their lower-tier formulary designs, but instead classify such medications as “lifestyle” drugs.

In a review that contributed to IOM’s comprehensive analysis of insomnia, a 2005 National Institutes of Health State-of-the-Science Conference issued the following statement on the treatment of the disorder:

Insomnia occurs in as many as a third of adult Americans, but although effective pharmacological treatments are available, it is significantly underdiagnosed and undermanaged by doctors and health plans.

Health plans should play a role in encouraging adequate treatment, according to several studies delivered at the NIH conference. But “management and treatment of sleep loss are rarely addressed by clinicians, despite the large toll on society. There are no formal treatment guidelines in primary or specialty care for dealing with sleep loss,” states the IOM’s April 2006 report Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem.

The IOM report concluded that appropriate diagnosis and treatment of insomnia can have a positive effect on reducing a patient’s consumption of health care resources. Such efforts can begin with efforts on the part of managed care plans to educate providers about the value of treating insomnia, according to the report. And plans can play an important role in establishing standardized definitions and coding protocols for treatment.

“Managed care organizations have generally viewed insomnia as having a limited effect on medical costs,” says Pete Fullerton, PhD, RPh, an associate professor at the University of Washington School of Pharmacy in Seattle. “But major strides have been made in understanding and measuring the economic impact of insomnia, and that effect is considerable.”

Formulary design

It is in the arena of formulary design that managed care can be particularly influential in the treatment of chronic insomnia. According to guidelines issued by the Food and Drug Administration and by pharmaceutical manufacturers, decisions about inclusion of sleep agents in formulary design should be related to the severity of symptoms and the likelihood that short-term insomnia, if untreated, could progress into the more chronic condition.

According to the FDA, the ideal sleep agent has a quick onset of action to decrease sleep latency, a duration of action that prevents early morning awakenings, and minimal side effects. The FDA also recommends that the lowest effective dose of an agent should be used and that medications be used for short periods and intermittently, based on the individual patient’s return to an acceptable sleep cycle.

The classes of prescription medications that are used for treatment include benzodiazepines, benzodiazepine-receptor agonists, nonbenzodiazepines, sedating antidepressants, barbiturates, and even anticonvulsants. A new classification of nonbenzodiazepines has demonstrated effectiveness and may offer fewer and less severe side effects than older drugs.

Pharmacological treatment of insomnia is cost effective, according to the IOM report. Selection of the most appropriate treatment with the lowest doses, the shortest duration and minimal side effects represents a growing and imperative challenge to managed care.

Contributing Editor Martin Sipkoff is a long-time health care journalist.

Classifications of adult insomnia

According to the International Classification of Sleep Disorders published by the American Academy of Sleep Medicine (2005), insomnia can be classified by its symptomology and severity:

Primary insomnia:

  • Idiopathic insomnia — Insomnia arising in infancy or childhood with a persistent, unremitting course
  • Psychophysiologic insomnia — Insomnia due to a maladaptive conditioned response in which the patient learns to associate the bed environment with heightened arousal rather than sleep; onset often associated with an event causing acute insomnia, with the sleep disturbance persisting despite resolution of the precipitating factor
  • Paradoxical insomnia (sleep-state misperception) — Insomnia characterized by a marked mismatch between the patient’s description of sleep duration and objective polysomnographic findings

Secondary insomnia

  • Adjustment insomnia — Insomnia associated with active psychosocial stressors
  • Inadequate sleep hygiene — Insomnia associated with lifestyle habits that impair sleep
  • Insomnia due to a psychiatric disorder — Insomnia due to an active disorder such as anxiety or depression
  • Insomnia due to a medical condition — Insomnia due to a condition such as the restless legs syndrome, chronic pain, nocturnal cough or dyspnea, or hot flashes
  • Insomnia due to a drug or substance — Insomnia due to consumption or discontinuation of medication or due to use of recreational drugs, alcohol, or caffeine