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Cognitive behavioral therapy, pharmacologic therapy can effectively manage patients with insomnia, expert panel agrees

Wednesday, December 12 2007 | Comments

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What's This? Insomnia can be treated effectively using pharmacologic therapy, cognitive behavioral therapy, or a combination of the 2 strategies, according to a panel of experts.

A variety of drugs are commonly prescribed to treat insomnia, many of which are not approved by the Food and Drug Administration for this indication. These drugs have unique advantages and disadvantages that should be considered carefully before making a treatment decision, according to Dr. Ruth Benca with the University of Wisconsin School of Medicine and Public Health.

Sedating antidepressants represented 3 of the 4 most commonly prescribed drugs for treating insomnia in 2002, Dr. Benca noted, despite a lack of FDA approval in this indication. She said practitioners often seek to "kill 2 birds with 1 stone" by simultaneously treating any underlying depression, but she also said these drugs are unlikely to have any substantial effect on depression at the doses normally prescribed to treat insomnia.

Dr. Benca cited misconceptions regarding the safety and abuse potential of hypnotics, such as certain benzodiazepines, as another reason physicians sometimes choose to prescribe sedating antidepressants, even though the hypnotics are approved for the treatment of insomnia.

"There is this assumption that nonscheduled substances are automatically safer," she said. "There are risks to all drugs, and we're always trying to find the best risk-benefit ratio for our patients.

"The disadvantages of antidepressants are that ... they may not be as effective as some of the approved hypnotics and they have quite a number of side effects ... including daytime sedation or hangover, ... weight gain, ... and anticholinergic and cardiotoxic effects," Dr. Benca noted. She also mentioned the risk of inducing mania among patients with bipolar disorder and the black box warning regarding increased suicidal thinking and behavior in certain patients as other disadvantages associated with antidepressants.

Atypical antipsychotics, including olanzapine, quetiapine, risperidone, and ziprasidone, are also commonly prescribed to treat insomnia, even though they are also not approved for this indication.

Atypical antipsychotics have the benefits of anxiolytic effects, mood stabilization among patients with bipolar disorder, and low abuse potential, according to Dr. Benca, but they carry many of the same side effects as antidepressants do, along with increased risk of extrapyramidal effects and metabolic abnormalities and a black box warning regarding increased mortality among elderly patients with dementia-related psychosis.

Hypnotic drugs, including benzodiazepines and benzodiazepine receptor agonists (BzRAs), are approved by the FDA to treat insomnia and largely target the gamma-aminobutyric acid receptors involved in the sleep-promoting pathways.

"The approved benzodiazepine hypnotics ... are generally older agents," Dr. Benca said. "These drugs have very long half-lives and ... are associated with hangover the next day, or build-up when taken on a nightly basis."

She added, however, that the longer half-lives may be beneficial in increasing patients' total sleep time and may also decrease waking during the night through suppression of arousal.

BzRAs, including zaleplon and zolpidem, have a more rapid onset of action than benzodiazepines do, as well as substantially reduced half-lives, which can reduce the risk of hangovers and build-up. However, they share many of the side effects associated with benzodiazepines, including headache, drowsiness, and nausea, and a potential for dependence and/or abuse in vulnerable populations, Dr. Benca noted.

Melatonin receptor agonists are another class of drugs prescribed to treat insomnia, although ramelteon is the only drug in the class that is approved for this indication. Ramelteon has no limitations on duration of use and is not a controlled substance, but its effects have only been demonstrated in reducing sleep onset latency, thereby making it less desirable for treating issues with total sleep time or sleep continuity, according to Dr. Benca.

Regarding nonpharmacologic treatment, Dr. Benca noted that the National Institutes of Health's 2005 state-of-the-science statement regarding the treatment of insomnia included "one unequivocal statement ... that cognitive behavior therapy (CBT) is effective, unlikely to have adverse effects, and may provide long-lasting benefits ...."

In addition to these benefits, CBT has the further advantages of superior effect size and greater durability of benefits as compared with pharmacologic therapy, according to Dr. Karl Doghramji, director of the Jefferson Sleep Disorders Center at Thomas Jefferson University Hospital in Philadelphia.

"Generally speaking, behavioral cognitive therapies stack up pretty close in terms of efficacy to pharmacologic therapy, [and] in fact may be a little bit better when it comes to sleep onset latency," Dr. Doghramji said. "When you use pharmacotherapy, yes it works, we know that, but the benefits ... do not seem to last. [CBT] has more durable effect."

He further noted that CBT and pharmacotherapy should not be considered mutually exclusive.

"An interesting way to utilize [CBT] along with pharmacotherapy is to use it essentially to diminish the usage of medication," he said. "If you have people on [benzodiazepines] or hypnotics, one way to get them off of hypnotics is to gradually taper the hypnotic and to use [CBT]."

Depending on the needs of the patient, CBT can include stimulus control therapy to strengthen the bed and bedroom as sleep stimuli, relaxation therapies to reduce arousal and anxiety, sleep restriction to increase sleep debt and improve sleep continuity, cognitive therapy to dispel faulty beliefs that may perpetuate insomnia, paradoxic intention to relieve performance anxiety, sleep hygiene education to promote healthy sleep habits, or any combination of these techniques, according to Dr. Doghramji.

Despite the proven effectiveness and lack of side effects with CBT, there are several challenges to its widespread use in the treatment of insomnia.

"Unfortunately, there is a shortage of clinicians; many of us have not been trained to do [CBT]. Also there is an increased cost involved," Dr. Doghramji said. "One of the biggest challenges ... is to develop more cost-efficient ways of administering [CBT], such as group therapy, reducing the number of sessions, ... telephone sessions, ... and training nurses [to administer CBT]."

This information concerns uses that have not been approved by the FDA.

By Hunter Kaller

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