Zolpidem-CR may benefit depressed patients with severe insomnia

Routine prescription of a hypnotic medication does not appear to substantially reduce suicidal ideation in depressed outpatients with insomnia, but coprescription of such drug during antidepressant initiation may help suicidal outpatients, particularly those with severe insomnia, suggest the results of a study.

This 8-week, three-site, double-blind, placebo-controlled, parallel-group, randomized controlled trial compared controlled release zolpidem (zolpidem-CR) with placebo, in combination with an open-label selective serotonin reuptake inhibitor. Medication-free patients aged 18–65 years with major depressive disorder, insomnia and suicidal ideation were included.

The main outcome was suicidal ideation, measured first by the Scale for Suicide Ideation (SSI) and second by the Columbia–Suicide Severity Rating Scale (C-SSRS).

Of the 103 patients (mean age, 40.5 years; 64 women), 51 were randomized to receive zolpidem-CR and 52 to placebo.

Zolpidem-CR showed a strong anti-insomnia effect and was especially beneficial to patients with the most severe insomnia symptoms. The study drug had no significant effect on the SSI (least squares mean estimate, –0.56, 95 percent CI, –2.19 to 1.08; standard error [SE], 0.83), but the score reductions were significantly positively associated with improvement in insomnia after accounting for the effect of other depression symptoms.

On the other hand, zolpidem-CR showed a significant treatment effect (least squares mean estimate, –0.26, –0.50 to –0.02; SE, 0.12) as indicated by the C-SSRS. Of note, the treatment effect of zolpidem in reducing suicidal ideation on the C-SSRS was greater in patients with more severe insomnia.

Furthermore, there were no deaths or suicide attempts that occurred.