Efficacy and safety of Dimdazenil in primary insomnia and depressive episodes/bipolar depressive episode with insomnia: A post-marketing, randomized, open-label, positive-controlled study.

In 30 seconds

This randomized controlled trial evaluated the efficacy and safety of Dimdazenil in 185 patients with primary insomnia and depressive episodes/bipolar depressive episode with insomnia. Dimdazenil significantly increased subjective total sleep time (sTST) by 113.33 minutes from baseline (P < 0.001) and showed a mean between-group difference of +7.36 minutes compared to Midazolam.

Key findings

• Dimdazenil increased sTST by 113.33 minutes from baseline (P < 0.001).
• 59.49% of Dimdazenil patients achieved sTST≥390 min compared to 48.72% with Midazolam.
• Significant reductions in sleep latency and insomnia severity index were observed (both P < 0.001).
• 89.66% of treatment-emergent adverse events in the Dimdazenil group were mild.

Why it matters

The findings suggest that Dimdazenil may improve sleep quality and daytime functioning in patients with insomnia and depressive episodes, highlighting its potential as a treatment option in this population.