Taper Medication, Continue Behavioral Therapy Best Long-Term Approach for Chronic Insomnia

Pauline Anderson

May 21, 2009

May 21, 2009 — The first head-to-head comparison of treatment approaches to determine separate and combined effects on insomnia shows that adding a prescription sleeping pill to cognitive behavioral therapy (CBT) appears to be the optimal initial treatment approach in patients with persistent insomnia. However, after 6 weeks, tapering the medication and continuing with CBT alone produces the best long-term outcome.

The 2-phase study found that CBT plus zolpidem, a nonbenzodiazepine-receptor agonist, produced better rates of treatment remission compared with CBT alone (44.4% vs 39.2%) as well as treatment response (61.1% vs 59.5%) after 6 weeks.

However, more than a year later, patients who originally received the combined therapy and then received CBT alone had higher remission rates than patients who continued to take zolpidem (67.8% vs 41.8%).

These results suggest that there is a modest short-term added value to starting therapy with CBT plus a medication, especially with respect to total sleep gained, but that this added value does not persist, said Charles M. Morin, PhD, from Laval University and Canada Research Chair in Sleep Disorders, in Quebec City, Quebec.

“In terms of first-line therapy, I think that for acute insomnia lasting less than 6 months, medication is probably the best treatment approach, but for chronic insomnia, a combined approach might give us the best of both worlds," Dr. Morin told Medscape Psychiatry.

"However, after a few weeks, we need to think of discontinuing the medication and continuing with CBT. We just cannot continue prescribing medication indefinitely because it will not work," he added.

The study is published in the May 20 issue of the Journal of the American Medical Association.

Good Sleep Hygiene

Patients were recruited for the study from January 2002 to April 2005. They had to be at least 30 years old and meet diagnostic criteria for chronic insomnia. They had to have difficulty falling or staying sleep at least 3 nights per week and insomnia for longer than 6 months and experience significantly impaired daytime functioning due to insomnia. Patients could not be taking sleep medications at study outset.

After screening, 160 patients — 97 women and 63 men — were enrolled in the study. All were white and most were married or in common-law relationships. They had a mean age of 50.3 years and had experienced insomnia for a mean of 16.4 years.

For the first phase of the study, 80 patients were randomized to receive CBT alone and 80 to CBT plus daily zolpidem for 6 weeks. The therapeutic benefits of zolpidem are similar to those of benzodiazepine drugs, but it does not produce a generalized depression of the central nervous system. "It's more specific in terms of producing hypnotic effects without necessarily producing an anxiety-reducing effect or an anticonvulsant effect," said Dr. Morin.

All patients were instructed to go to bed only when tired at night, to use their bed only for sleep and sex, to get out of bed and go elsewhere when unable to fall asleep or return to sleep within 20 minutes, and to get up at the same time every morning.

Unrealistic Expectations

During this phase of the study, patients attended weekly, 90-minute CBT group-therapy sessions. The goal of therapy was to alter unrealistic sleep expectations such as the belief that one needs 8 hours of sleep every night to function during the day and other faulty beliefs about sleep and maladaptive behaviors that contribute to anxiety and sleeplessness. They also learned about the effects on sleep of caffeine, alcohol, exercise, excess noise and light, and extreme temperatures.

Patients in the combined-therapy group also took 10 mg of zolpidem daily 30 minutes before bedtime.

To assess sleep changes, researchers used patient sleep diaries and standard polysomnography. At regular intervals, patients also completed the Insomnia Severity Index (ISI), a 7-item, multiscaled assessment of sleep satisfaction and insomnia impact on daytime functioning.

The total ISI score ranges from 0 to 28, with a higher score indicating more severe insomnia. At baseline, patients had a mean ISI score in the moderate range — 17.3 for CBT alone and 17.6 for combined. Patients were considered treatment responders if their ISI score decreased by more than 7 units from baseline and remitters if their absolute ISI score was less than 8.

More Sleep Time

At the end of this 6-week phase, the combined approach appeared more beneficial than the CBT-alone approach, mostly in terms of gaining more sleep time. There were significant decreases in insomnia severity in both the CBT alone group (–8.3 units) and in the combined group (–8.8 units).

The researchers determined that 59.5% of the CBT-alone group and 61.1% of the combined group were responders and that 39.2% of the CBT-alone group and 44.4% of the combined group were remitters. "So here we have a slight advantage for the combined approach," said Dr. Morin.

For the second part of the study, 75 subjects who initially were randomized to take CBT alone went on to receive either monthly, individualized CBT sessions with no medication (38) or no additional treatment (37). From the initial combined-therapy group, 74 patients were randomized to a CBT-alone group (37) or to CBT plus zolpidem on an as-needed basis (37).

Patients in these treatment groups were assessed after a 6-month extended treatment phase and again 6 months later.

Steady Increase in Remission

The investigators found remission rates among patients originally in the combined group who continued with CBT but with no further medication increased steadily over time — from 44.4% after the 6-week phase to 56.9% after the 6-month phase and to 67.8% at the 6-month follow-up.

In comparison, the remission rates for those originally in the combined group who continued to receive both therapies increased from 44.4% during the 6-week phase to 59.8% during the 6-month phase but then dipped at the 6-month follow-up to only 41.7%.

In terms of response rates, the patients who started with combined therapy and continued with only the CBT had a rate of 80.9% by the 6-month follow-up, while those who started with combined therapy and continued with the CBT plus medication as needed had a rate of 64.8%.

"Overall, and in retrospect, it seemed that those who received the combined approach did better in the long run, but only if you tapered the medication after 6 weeks," said Dr. Morin.

Discontinuing the medication while patients are still receiving CBT makes for "good clinical practice," the authors write, adding that such an approach minimizes drug exposure and risks of dependence. However, they note, other factors, such as treatment availability, should also be considered.

Persistent Problem

One of the difficulties in treating insomnia is that studies of treatments rarely last beyond about 10 days, said Dr. Morin. "Typically, to get a new drug approved by the [Food and Drug Administration] FDA or Health Canada, you just need to show it's working for a short period of time and that there's no rebound effect when you discontinue it. But we know now that insomnia is oftentimes a very persistent or chronic problem, and we can't just think of short-term treatments, we need to think of long-term therapy," said Dr. Morin.

It's important to treat insomnia and not assume it will go away, he added. "We might end up with a second problem, because chronic insomnia is a risk factor for major depression."

The authors emphasized that there is no treatment that works for every patient with insomnia. Future studies should further investigate how best to integrate CBT and medication.

Asked by Medscape Psychiatry to comment on the findings, Donna Arand, PhD, from the Kettering Sleep Disorders Center, in Dayton, Ohio, said that the conclusion that patients do better in the long term if medication is stopped after 6 weeks and only CBT is continued during an additional 6-month period is an "important new finding."

"This provides valuable information for sleep specialists concerning the most effective treatment strategies for chronic insomnia, which the American Academy of Sleep Medicine estimates affects just under 10% of the population," she said.

Dr. Morin reports serving as a consultant to Actelion, Lundbeck, Sanofi-Aventis, Sepracor, and Schering-Plough. No other financial disclosures were reported.

JAMA. 2009;301:2005-2015. Abstract

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