Efficacy and safety of Shugan Jieyu capsules in combination with zolpidem for insomnia disorder with depressive symptoms: a double-blind randomized controlled trial.

ABSTRACT:

Objective

Insomnia disorder with depressive symptoms (IDDS) represents a significant clinical phenotype, with a bidirectional relationship where insomnia both contributes to and results from depression. This study aimed to assess the efficacy and safety of combining zolpidem with Shugan Jieyu in treating IDDS.

Methods

In a double-blind, randomized trial, 60 IDDS patients were assigned to zolpidem plus Shugan Jieyu (ZS) or zolpidem plus placebo (ZP) for 8 weeks, with 59 completing the study. Assessments included the Insomnia Severity Index (ISI), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder 7 (GAD-7), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), polysomnography (PSG), and sleep diary. Mixed-model repeated-measures (MMRM) analy

SUBMITTER: Xin Q 

PROVIDER: S-EPMC12535106 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature