CNS Neurosci Ther. 2025 Jun;31(6):e70470. doi: 10.1111/cns.70470.
ABSTRACT
AIMS: To explore the efficacy of Femoston plus escitalopram for perimenopausal women with chronic insomnia and the relevant biomarkers.
METHODS: A total of 166 patients randomly received: escitalopram plus placebo (Escitalopram Group), Femoston plus placebo (Hormone Group), and Femoston plus escitalopram (Combined Group) for 3 months and followed for 2, 4, 8, and 12 weeks. The primary efficacy endpoint was changes in Pittsburgh Sleep Quality Index Scale (PSQI), Insomnia Severity Index Scale (ISI), and Epworth Sleepiness Scale (ESS) scores at week 12 from baseline. Secondary endpoints included changes in the Modified Kupperman Menopausal Index Scale (KMI) scores, blood 5-HT neurotransmitters and their receptor, and blood sex hormone levels during the treatment.
RESULTS: Compared with baseline levels, all groups displayed increased serum 5-HT levels and decreased serum FSH levels, with more significant changes in the combined group. Compared with the other two groups, the combined group reported a gradual increase in serum E2 levels and a gradual decrease in serum LH levels, and the lowest KMI, ESS, ISI, and PSQI scores at weeks 4 and 12. The PSQI score was negatively correlated with serum 5-HT and E2 and positively correlated with serum FSH and LH levels, respectively.
CONCLUSION: Femoston plus escitalopram improves chronic insomnia in perimenopausal women. Serum levels of 5-HT, E2, FSH, and LH may objectively indicate the clinical severity of chronic insomnia in this population.
PMID:40509584 | DOI:10.1111/cns.70470
