Abstract | 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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Authors | William V McCall, Ruth M Benca, Peter B Rosenquist, Nagy A Youssef, Laryssa McCloud, Jill C Newman, Doug Case, Meredith E Rumble, Steven T Szabo, Marjorie Phillips, Andrew D Krystal |
Journal | The American journal of psychiatry
(Am J Psychiatry)
Vol. 176
Issue 11
Pg. 957-965
(11 01 2019)
ISSN: 1535-7228 [Electronic] United States |
PMID | 31537089
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Chemical References |
- Delayed-Action Preparations
- Serotonin Uptake Inhibitors
- Sleep Aids, Pharmaceutical
- Zolpidem
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Topics |
- Adolescent
- Adult
- Aged
- Delayed-Action Preparations
(therapeutic use)
- Double-Blind Method
- Drug Therapy, Combination
(methods)
- Female
- Humans
- Male
- Middle Aged
- Selective Serotonin Reuptake Inhibitors
(therapeutic use)
- Sleep Aids, Pharmaceutical
(therapeutic use)
- Sleep Initiation and Maintenance Disorders
(drug therapy)
- Suicidal Ideation
- Young Adult
- Zolpidem
(therapeutic use)
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