Rx CARE

Revised guidelines offer new ways to manage insomnia

How often do your patients seek advice for insomnia? With more than 84 million Americans affected by insomnia, you probably get such questions quite frequently. Despite its prevalence, insomnia receives little attention from the health-care community even though the effects on the quality of life can be severe. In response to this lack of awareness, an international panel of sleep experts has issued new insomnia management guidelines, published in the March issue of the International Journal of Clinical Practice.

During the past several years, three main developments have come into focus, highlighting the need for the new guidelines: the nature of insomnia symptom disorder, the increased knowledge of morbidity associated with insomnia, and the evolution of new pharmacotherapy options.

"We now recognize that although insomnia can be a symptom of another condition, 20%-30% of patients suffer from insomnia as a primary disease, with no underlying condition," declared lead author Thomas Roth, Ph.D., the director of research and division head of the Sleep Disorders and Research Center at Henry Ford Health System in Detroit. While identifying and treating potential underlying conditions are priorities in the management of insomnia, the guidelines stress that it is crucial that insomnia be considered a serious medical disorder in its own right.

Several studies have been done defining the morbidity of insomnia. These studies have shown insomnia to be associated with a greater risk of depression, decreased productivity, increased absenteeism, increased health-care utilization, and impaired cognitive functioning. Given these data, Roth acknowledged, "insomnia is typically underrecognized, underdiagnosed, and undertreated, and we are faced with the challenge to show that treating insomnia reverses morbidity." He feels that the lack of proper education on sleep management in medical school ("typically one to two hours primarily on sleep apnea") and the tendency by the medical community to minimize the morbidity factor contribute to the inadequate diagnosing and treatment of insomnia.

The guidelines, titled Consensus for the Pharmacological Management of Insomnia in the New Millennium, recommend that once a proper diagnosis is made, various treatment modalities should be considered. Nonpharmacological therapies include good sleep hygiene—avoiding caffeine and exercise right before retiring, setting a regular bedtime schedule, and limiting the use of the bedroom to sleeping and sex so that bedtime will be viewed as a time to sleep rather than watch TV or complete work.

When the initial guidelines, sponsored by the National Institute of Mental Health, were written in 1983, the long-acting benzodiazepines were the only agents available for the treatment of insomnia. A series of guidelines have been published since then, with this latest one designed to disseminate the most up-to-date information to primary care physicians. As Roth explained, "We now have compounds that have advanced our ability to treat insomnia ... [such as] nonbenzodiazepines and shorter-acting agents without residual effects ... which allows us to treat insomnia not only prophylactically but also symptomatically." He stressed, however, that we also have to face the tremendous amount of prejudice against drugs that work on the GABA receptor and the belief that there is a high rate of addiction associated with benzodiazepine use.

Roth asserted that this assumption is "ludicrous" and that the number of actual abusers is "very small." One of the points the guidelines make is that "while chronic therapy is necessary in a lot of patients, nightly therapy isn't always needed." The guidelines emphasize that one of the advancements in long-term management is to give drug therapy only in response to the occurrence of symptoms. This approach permits long-term therapy without the use of nightly medication.

Because of the potential problem with the benzodiazepine sedative hypnotics—residual daytime sedation, psychomotor and cognitive impairment, anterograde amnesia, and rebound insomnia—novel nonbenzodiazepine benzodiazepine-receptor agonists were developed, including zolpidem (Ambien, Searle), zaleplon (Sonata, Wyeth-Ayerst), and zopiclone (made by Sepracor), which is undergoing clinical trials in the United States.

According to the guidelines, the drug that seems to have the overall advantage is zaleplon, which has been effective for treating both chronic insomnia and transient insomnia, without causing the side effects associated with the older drugs. The rapid onset of action of zaleplon allows for administration during the night for patients with sleep-maintenance insomnia, provided the patient remains in bed for at least four hours before becoming active again. The rationale for taking zaleplon in direct response to, rather than in anticipation of, the symptoms is to avoid routine use.

"The fear of a 'hangover effect' the next day, along with the risk of dependence associated with many sleeping pills, may have kept some patients from seeking therapy," said Roth. "These concerns can be eliminated by combining newer medications with careful monitoring by a physician."

Of course, if all else fails, you can always recommend counting sheep.

Tammy Chernin, R.Ph.

DEFINITION OF PRIMARY INSOMNIA

• Difficulty initiating or maintaining sleep, or experiencing nonrestorative sleep for at least one month

• Significant impairment in social, occupational, or other important areas of functioning

• Sleep disturbance does not occur exclusively during the course of another sleep or mental disorder and is not caused by direct physiological effects of a substance or general medical condition

Source: Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)

 

Tammy Chernin. Revised guidelines offer new ways to manage insomnia. Drug Topics 2001;8:23.