Behavioral therapy was comparable to zolpidem medication for the treatment of patients with insomnia disorder, according to study data published in JAMA Psychiatry.
Researchers enrolled adults with insomnia disorder from 2 mental health treatment centers in Canada and the United States in a randomized clinical trial from August 2012 through 2017 (ClinicalTrials.gov Identifier: NCT01651442).
Patients were randomly assigned to receive either behavioral therapy or zolpidem for 6 weeks on a 1:1 basis. Randomization was stratified by gender, age (under vs over 55 years), study site, and the presence of psychological comorbidities. Patients who remitted were followed for an additional 12 months while receiving maintenance therapy. Those who did not remit received 6 weeks of secondary treatment with zolpidem, trazodone, behavioral therapy, or cognitive therapy.
The primary endpoints were treatment response and remission, assessed using the Insomnia Severity Index (ISI) at baseline, week 6, week 12, month 6, and month 12. Response was defined as a reduction of 8 points or more on the ISI; remission was defined as an ISI score <8. Logistic regression analyses were used to assess the likelihood of response and remission in each group.
The cohort comprised 211 adults (mean age, 45.6±14.9 years; 62.6% women), with 104 receiving behavioral therapy and 107 receiving zolpidem. Whereas 74 patients (35%) had a comorbid anxiety or mood disorder, 137 (68%) had at least 1 comorbid medical condition.
Response rates were comparable between the behavioral therapy and zolpidem arms (45.5% vs 59.7%; odds ratio [OR], 1.18; 95% CI, 0.60-2.33). Additionally, 6 week remission rates were similar between the 2 groups (38.03% vs 30.3%; OR, 1.41; 95% CI, 0.75-2.65).
Among patients who did not remit with behavioral therapy, those who switched to zolpidem (40.6% to 62.7%; OR, 2.46; 95%CI, 1.14-5.30) or cognitive therapy (50.1% to 68.2%; OR, 2.09; 95% CI, 1.01-4.35) were more likely to respond. Conversely, patients who switched from zolpidem to behavioral therapy or cognitive therapy were not more likely to achieve treatment response. The addition of second stage therapy also increased the likelihood of remission in patients who switched from behavioral therapy to zolpidem (38.1% to 55.9%). Increased remission rates were not observed with other second line treatments.
Improvements achieved at the end of first and second stage therapies were maintained over 12 months of follow-up. While initial response and remission rates were nominally lower among patients with comorbid psychiatric disorders, this group responded well to second line cognitive therapy and trazodone.
These data outline the utility of both behavioral therapy and medication for the treatment of insomnia disorders. Behavioral therapy and zolpidem yielded comparable results over 6 weeks of follow-up. The addition of a second treatment tended to have positive results for patients who did not remit with their initial therapies.
“The presence of psychiatric comorbidity was associated with less favorable outcome during initial therapy,” the investigators concluded, “but within the subgroup of patients with comorbid psychiatric disorders, response and remission rates were higher for patients who received either [cognitive therapy] or trazodone as second-stage treatment.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry.
Please see the original reference for a full list of authors’ disclosures.
Morin CM, Edinger JD, Beaulieu-Bonneau S, et al. Effectiveness of sequential psychological and medication therapies for insomnia disorder: a randomized clinical trial [published online July 8, 2020]. JAMA Psychiatry. doi:10.1001/jamapsychiatry.2020.1767