Takeaway
- The addition of controlled-release zolpidem (zolpidem-CR) to a selective serotonin reuptake inhibitor (SSRI) was superior to placebo plus an SSRI in reducing insomnia symptoms in suicidal patients with major depressive disorder.
- The addition of zolpidem-CR demonstrated greater reductions in suicidality vs placebo, as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS).
Why this matters
- Although the results do not support the routine prescription of hypnotic medication for mitigating suicidal ideation, they suggest that the co-prescription of a hypnotic during initiation of an antidepressant may be beneficial in suicidal outpatients, especially in patients with severe insomnia.
Study design
- REST-IT trial randomly assigned 103 participants (aged, 18-65 years) who were medication-free with major depressive disorder, insomnia, and suicidal ideation to receive zolpidem-CR hypnotic therapy (n=51) or the placebo (n=52), in conjunction with an open-label SSRI.
- Primary outcome: suicidal ideation.
- Funding: None disclosed.
Key results
- No significant treatment effect was observed on the Scale for Suicide Ideation (least squares mean estimate, −0.56; P=.50).
- Compared with placebo, zolpidem-CR showed a significant improvement in severe insomnia symptoms (mean Insomnia Severity Index scores, −5.23; standard error [SE]=0.83; 95% CI, -2.19 to -1.08).
- C-SSRS scores favoured zolpidem-CR over placebo (P=.035); least mean scores for treatment effect, −0.26; SE=0.12; 95% CI, -0.50 to -0.02).
- Zolpidem-CR showed greater reduction in C-SSRS suicidal ideation scores in those participants with severe baseline insomnia (mean=20.41, SE=0.21) relative to those with mild to moderate baseline insomnia (mean=20.08, SE=0.15).
- No deaths or suicide attempts were noted during the study.
Limitations
- Suicidal patients with an active plan and imminent intent for suicide were excluded.
References
References
