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.

OBJECTIVES

To assess the efficacy and safety of Dimdazenil in primary insomnia and depressive episodes/bipolar depressive episode with insomnia.

METHODS

In this post-marketing, positive-controlled study, eligible patients were assigned 1:1 to receive either Dimdazenil 2.5 mg or Midazolam 15 mg (minimum 3 doses/week) over 14 days. The primary endpoint was the between-group difference in subjective total sleep time (sTST) on Day 14.

RESULTS

185 patients were included (Dimdazenil, N = 93; Midazolam, N = 92). Dimdazenil significantly increased sTST from baseline (LSM difference, +113.33 min, P < 0.001), with a mean between-group difference of +7.36 min versus Midazolam. A higher proportion of patients in the Dimdazenil group achieved sTST≥390 min (59.49% vs. 48.72%) and sTST≥8 h (34.8% vs. 23.1%). Significant reductions from baseline were also observed in sSL and ISI (both P < 0.001). Daytime functioning was significantly improved with Dimdazenil, as evidenced by marked reductions in ESS, FFS, and TMT-A completion time (all P < 0.001). Moreover, FFS decreased more from baseline with Dimdazenil than Midazolam (-3.86 vs. -2.48). Descriptive improvements in sWASO, sNAW, and FFS scores were observed in patients with depressive episodes/bipolar depressive episode with insomnia. Most TEAEs in the Dimdazenil group were mild (89.66%, 26/29), with no severe TEAE or death reported.

CONCLUSIONS

In this exploratory study, Dimdazenil was associated with improvements in subjective sleep parameters and daytime functioning in patients with primary insomnia and depressive episodes/bipolar depressive episode with insomnia. Improvements in sleep maintenance outcomes and in patients with depressive episodes/bipolar depressive episode with insomnia warrant further investigation in adequately powered confirmatory studies.

CLINICAL TRIAL REGISTRATION: This study was registered on the Chinese Clinical Trial Registry (https://www.chictr.org.cn; registration number: ChiCTR2400085915).