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For the treatment of insomnia, we already have head-to-head comparisons of medications vs psychotherapy, specifically CBTI, cognitive–behavioral therapy for insomnia. In multiple trials, CBTI worked as well as medications like zolpidem or trazodone with fewer risks in both the short and long term. These results have led to practice guidelines suggesting CBTI first, then medications only if CBTI is not effective or not accessible. But what if CBTI or CBT doesn’t work? What should you do then?
Hi! Jim Phelps here for the Psychopharmacology Institute. Wouldn’t it be great to see a comparison of insomnia treatments like CBT vs medications carried out for, say, a year and compare how people did if they got medications first or CBT first? Well, here’s one.
In this article by Charles Morin and colleagues, we see a comparison of 4 arms, each with 12-month follow-up periods. People with primary insomnia not secondary to a psychiatric or other medical problem were randomized to either zolpidem or behavioral therapy. That’s CBTI without the cognitive component about misconceptions about sleep needs and perceived consequences and worries about sleep loss, since the cognitive component was added separately later in nonresponders.
In this first step, we see the outcome that led to the practice guidelines, which is equal response and remission rates for zolpidem and behavioral therapy. Following this, the investigators took the nonremitters and randomized them again. Those who had behavioral therapy in the first stage and failed to remit went on to either a medication approach, zolpidem, or they continued a nonmedication approach by adding the cognitive component of CBTI. The other 2 groups in this 4-arm study came from those who had not remitted on zolpidem in the first stage. They were randomized to either the behavioral therapy or a different medication approach, namely, trazodone.
All 4 groups were then followed for a year, and here’s what they found. On the main outcome measure, which was the patient-rated Insomnia Severity Index, all 4 groups improved with the second-step treatment and went on to maintain or slightly improve on those gains over the following months to 1 year. The exception, which was the worst combination, was to get zolpidem first, fail to remit, and then receive behavioral therapy. This group failed to increase its response rate even after the end of the second stage, while the other 3 groups did. In other words, the current guidelines were upheld. It’s best to start with a behavioral therapy, and if that doesn’t work well enough, add cognitive therapy or zolpidem. The other way around—zolpidem first, then behavioral therapy—is not recommended.
What about access to these behavioral approaches? Well, that’s a problem, all right. Many don’t offer it because they’re too busy with patients who need medications for many other things. And unless you’re lucky, you can’t reliably get patients right over to someone who can do a behavioral approach. This is an access problem which ought to be helped by the availability of a free app from the Stanford Sleep Lab that basically provides the entire therapy. The provider needs only to guide the patient into and through the app. All the sleep hygiene stuff is there, as well as all the calculations for bedtimes and rise times for the sleep restriction component of CBTI.
If you haven’t seen this app, Google “CBT-i Coach,” or download the app of the same name. As some patients may not have the ability to download and use a program like this, you can even train someone in your office to help patients with the download and a walkthrough of the program. Short of that, you really need to find a local therapist who can offer a behavioral therapy for insomnia because that’s the first-line treatment.
This new article from Morin and colleagues reaffirms that treatment order and shows that the benefits continue without diminution from one-time treatment as opposed to continuing pharmacotherapy.
For more on this, the place to go—if you’re not already using it—is CBT-i Coach.
Abstract
Effectiveness of Sequential Psychological and Medication Therapies for Insomnia Disorder: A Randomized Clinical Trial
Charles M Morin, Jack D Edinger, Simon Beaulieu-Bonneau, Hans Ivers, Andrew D Krystal, Bernard Guay, Lynda Bélanger, Ann Cartwright, Bryan Simmons, Manon Lamy, Mindy Busby
Importance: Despite evidence of efficacious psychological and pharmacologic therapies for insomnia, there is little information about what first-line treatment should be and how best to proceed when initial treatment fails.
Objective: To evaluate the comparative efficacy of 4 treatment sequences involving psychological and medication therapies for insomnia and examine the moderating effect of psychiatric disorders on insomnia outcomes.
Design, setting, and participants: In a sequential multiple-assignment randomized trial, patients were assigned to first-stage therapy involving either behavioral therapy (BT; n = 104) or zolpidem (zolpidem; n = 107), and patients who did not remit received a second treatment involving either medication (zolpidem or trazodone) or psychological therapy (BT or cognitive therapy [CT]). The study took place at Institut Universitaire en Santé Mentale de Québec, Université Laval, Québec City, Québec, Canada, and at National Jewish Health, Denver, Colorado, and enrollment of patients took place from August 2012 through July 2017.
Main outcomes and measures: The primary end points were the treatment response and remission rates, defined by the Insomnia Severity Index total score.
Results: Patients included 211 adults (132 women; mean [SD] age, 45.6 [14.9] years) with a chronic insomnia disorder, including 74 patients with a comorbid anxiety or mood disorder. First-stage therapy with BT or zolpidem produced equivalent weighted percentages of responders (BT, 45.5%; zolpidem, 49.7%; OR, 1.18; 95% CI, 0.60-2.33) and remitters (BT, 38.03%; zolpidem, 30.3%; OR, 1.41; 95% CI, 0.75-2.65). Second-stage therapy produced significant increases in responders for the 2 conditions, starting with BT (BT to zolpidem, 40.6% to 62.7%; OR, 2.46; 95% CI, 1.14-5.30; BT to CT, 50.1% to 68.2%; OR, 2.09; 95% CI, 1.01-4.35) but no significant change following zolpidem treatment. Significant increase in percentage of remitters was observed in 2 of 4 therapy sequences (BT to zolpidem, 38.1% to 55.9%; OR, 2.06; 95% CI, 1.04-4.11; zolpidem to trazodone, 31.4% to 49.4%; OR, 2.13; 95% CI, 0.91-5.00). Although response/remission rates were lower among patients with psychiatric comorbidity, treatment sequences that involved BT followed by CT or zolpidem followed by trazodone yielded better outcomes for patients with comorbid insomnia. Response and remission rates were well sustained through the 12-month follow-up.
Conclusions and relevance: Behavioral therapy and zolpidem medication produced equivalent response and remission rates. Adding a second treatment produced an added value for those whose insomnia failed to remit with initial therapies.
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Reference
Morin, C. M., Edinger, J. D., Beaulieu-Bonneau, S., Ivers, H., Krystal, A. D., Guay, B., Bélanger, L., Cartwright, A., Simmons, B., Lamy, M., & Busby, M. (2020). Effectiveness of sequential psychological and medication therapies for insomnia disorder: A randomized clinical trial. JAMA Psychiatry, 77(11), 1107.
