Comprehensive approach helps patients get a good night's sleep

What should doctors tell patients about insomnia medications?

The Ethics Group provides discussions on questions of ethics and professionalism in medical practice. Readers are encouraged to submit questions and comments to [email protected], or to Ethics Group, AMA, 515 N. State St., Chicago, IL 60654. Opinions in Ethics Forum reflect the views of the authors and do not constitute official policy of the AMA. Posted Nov. 7, 2011.

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Recent articles in the media have caused confusion about side effects and harm from overdoses. Some suspect the profession is overprescribing.

Reply: Insomnia is the most common sleep-related complaint in adults. Chronic insomnia is thought to be present in up to 15% of the population. In the U.S. alone, untreated insomnia, excluding comorbid disorders, has an annual estimated cost of 252.7 million days of lost work performance each year and a corresponding dollar loss of $63.2 billion.

So it is important that effective therapies be developed, validated and administered. The trial of Michael Jackson's doctor clearly illustrates the extreme measures that patients employ to get a decent amount of sleep. Though many patients tend to desire a "quick fix" for their sleep problem, the ethical challenge for physicians is to insist on a comprehensive plan of evaluation, treatment and follow-up that will promote long-term health and overall well-being.

Epidemiological surveys have shown that the most common treatments used by people with chronic insomnia are over-the-counter sleep aids, self-medication with alcohol and prescription medications. The OTC sleep aids usually are antihistamines, which have no systematic evidence for efficacy and can pose significant risks, particularly in vulnerable populations like the elderly. The adverse effects of alcohol on sleep are well-documented, prohibiting it from being recommended for chronic usage.

Physicians often prescribe nonhypnotic medications such as antidepressants for sleep inducement. This off-label use of antidepressants also has potentially significant adverse effects and raises concerns about the risk-benefit ratio. Little research is available on antidepressant use for sleep in nondepressed patients. However, many drugs, like trazodone, are commonly prescribed in this way. Similarly, other sedating medications (barbiturates, e.g., phenobarbital and benzodiazepines) and antipsychotics (e.g., quetiapine and olanzapine) are prescribed for insomnia. These drugs also pose significant risks due to side effects and, therefore, should not be recommended for chronic use.

Diagnosing a sleep problem

The initial approach to a patient with insomnia must include obtaining information about the possible causes. The history is key to determining whether a comorbid medical or psychiatric disorder is playing an important role. Asking about the sleep environment, sleep habits, new stressors and medications may lead to a potential etiology. Prescribing a pill may be the easiest thing to do in a busy practice, but this response is not a good long-term solution.

When considering treatment, the primary goals are to improve sleep quality and quantity and reduce insomnia-related daytime impairments. The two large classes of therapy -- pharmacologic and behavioral -- are not mutually exclusive. For the best long-term outcomes, behavioral therapy should be part of any management plan.

The newer hypnotics have several advantages over older ones, including a rapid effect, availability, low side-effect profile, small abuse or dependence risk, appropriate half-life to avoid hangover effect and safety of nightly use for many months. However, regular long-term prescribing of a hypnotic is not preferred for the majority of patients, and most patients should have a trial of behavioral therapy. Behavioral therapies include relaxation training, stimulus control and sleep restriction, and often are combined with cognitive therapy in which anxiety-producing beliefs and erroneous beliefs about sleep and sleep loss are targets for cognitive restructuring. This cognitive behavioral therapy for insomnia (CBT-I) can be effective in treating chronic insomnia patients, but few clinicians are experts in the use of CBT-I. Referral to a sleep medicine specialist or sleep center may be indicated for patients with continued insomnia complaints.

Sleep medicine specialists advocate that pharmacologic interventions be prefaced by stating the importance of good sleep hygiene as a necessary component of every treatment package. This includes addressing the following types of issues:

  • Environmental (temperature, noise level, ambient light).
  • Scheduling (regular sleep-wake schedule).
  • Sleep practice (bedtime routine).
  • Physiologic (exercise, timing of meals, caffeine use).

Patients who are prescribed a hypnotic should be followed every few weeks in the initial period of treatment to assess for effectiveness, possible side effects and the need for ongoing medication. For many patients, an initial treatment period of two to four weeks may be appropriate, followed by re-evaluation of the continued need for treatment.

One should start at the lowest end of the dosage range and titrate up only if necessary. Continued efforts should be made at tapering, either the dose or the number of days used; this can reduce the likelihood of rebound insomnia and withdrawal symptoms. This may be a tedious process, and successful tapering may require weeks to months.

A lesson in sleep medications

Physicians should educate patients about the prescribed sleep medicine, including the indications for use, dosage and side effects. Side effects, including sleepwalking, sleep eating, other complex sleep behaviors and memory problems, may occur in a minority of patients. I always suggest that patients take the first dose on a night when they don't have to go anywhere the next morning; it is also critical for patients to be aware that a sleep medication should never be combined with alcohol.

Use caution when prescribing to seniors. Studies have shown that residual effects from hypnotics may be a factor in falls and accidents among older adults. Lower doses may be required in older adults, and the potential for side effects and drug interactions should be considered carefully.

Some patients require long-term use (more than six months). Ideally, this will not involve nightly use of a hypnotic. However, some patients may have that need, particularly in the setting of refractory insomnia or chronic comorbidities. Recent randomized, controlled studies of the nonbenzodiazepine hypnotic medications (such as eszopiclone or zolpidem) have shown continued effectiveness for up to six months, with open-label extension trials having similar results for more than 12 months. If hypnotic medications are used long-term, visits should be scheduled every six months at a minimum to monitor efficacy, side effects and tolerance.

This is especially true if the physician suspects drug-seeking behavior for hypnotics. The evaluation should include all the elements discussed above -- the specific insomnia issues, the types of medications or alternative therapies they have tried in the past, and their expectations about sleep. Addressing unrealistic expectations about sleep and using CBT-I techniques are the best approaches to helping patients lose their hypnotic dependency.

Hypnotic medications have been the subject of a relatively large number of placebo-controlled trials establishing their efficacy, side effects and attributes in the treatment of insomnia. These drugs can be helpful in managing patient sleep complaints. However, for chronic sleep issues, hypnotics should be combined with cognitive behavioral therapies or follow an initial trial of CBT-I for the best long-term results.

Nancy Collop, MD, president of the American Academy of Sleep Medicine; director of the Emory Sleep Center, Wesley Woods Health Center, Atlanta; professor in the Division of Pulmonary, Allergy and Critical Care Medicine, Emory School of Medicine, Atlanta

The Ethics Group provides discussions on questions of ethics and professionalism in medical practice. Readers are encouraged to submit questions and comments to [email protected], or to Ethics Group, AMA, 515 N. State St., Chicago, IL 60654. Opinions in Ethics Forum reflect the views of the authors and do not constitute official policy of the AMA.

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External links

"Clinical Guideline for the Evaluation and Management of Chronic Insomnia in Adults," Journal of Clinical Sleep Medicine, Oct. 15, 2008 (link)

"Insomnia and the performance of US workers: results from the America insomnia survey," Sleep, September (link)

"Unhealthy Sleep-Related Behaviors -- 12 States, 2009," Morbidity and Mortality Weekly Report, March 4, Centers for Disease Control and Prevention (link)

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