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Reducing Suicidal Ideation Through Insomnia Treatment (REST-IT): A Randomized Clinical Trial
William V McCall1, Ruth M Benca1, Peter B Rosenquist1
1Department of Psychiatry and Health Behavior, Medical College of Georgia at Augusta University (McCall, Rosenquist, Youssef, McCloud), and the Pharmacy Department, Augusta University Health (Phillips), Augusta, Ga.; Department of Psychiatry and Human Behavior, University of California, Irvine, Irvine (Benca); Department of Medicine, Medical University of South Carolina, Charleston (Newman); Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, N.C. (Case); Department of Psychiatry, University of Wisconsin School of Medicine and Public Health, Madison (Rumble); Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, N.C. (Szabo, Krystal); Durham VA Health Care System, Durham, N.C. (Szabo); Langley Porter Psychiatric Hospital and Clinics and Department of Psychiatry, University of California, San Francisco, San Francisco (Krystal).
Objective:
The authors sought to determine whether targeted treatment of insomnia with controlled-release zolpidem (zolpidem-CR) in suicidal adults with insomnia would provide a reduction in suicidal ideation superior to placebo.
Methods:
Reducing Suicidal Ideation Through Insomnia Treatment was an 8-week three-site double-blind placebo-controlled parallel-group randomized controlled trial of zolpidem-CR hypnotic therapy compared with placebo, in conjunction with an open-label selective serotonin reuptake inhibitor. Participants were medication-free 18- to 65-year-olds with major depressive disorder, insomnia, and suicidal ideation. Suicidal ideation was the main outcome, measured first by the Scale for Suicide Ideation and second by the Columbia-Suicide Severity Rating Scale (C-SSRS).
Results:
A total of 103 participants were randomly assigned to receive zolpidem-CR (N=51) or placebo (N=52) (64 women and 39 men; mean age=40.5 years). Zolpidem-CR had a robust anti-insomnia effect, especially in patients with the most severe insomnia symptoms. No significant treatment effect was observed on the Scale for Suicide Ideation (least squares mean estimate=-0.56, SE=0.83, 95% CI=-2.19, 1.08), but the reduction in scores was significantly positively related to improvement in insomnia after accounting for the effect of other depression symptoms. The C-SSRS indicated that zolpidem-CR had a significant treatment effect (least squares mean estimate=-0.26, SE=0.12, 95% CI=-0.50, -0.02). The advantage for zolpidem-CR in reducing suicidal ideation on the C-SSRS was greater in patients with more severe insomnia. No deaths or suicide attempts occurred.
Conclusions:
Although the results do not support the routine prescription of hypnotic medication for mitigating suicidal ideation in all depressed outpatients with insomnia, they suggest that coprescription of a hypnotic during initiation of an antidepressant may be beneficial in suicidal outpatients, especially in patients with severe insomnia.
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