Sedative effects of a traditional polyherbal formulation (Monavvem) in patients with chronic insomnia: A randomized double-blind placebo-controlled trial

Introduction: Chronic insomnia is a common disorder that affects more than a third of the world's adult population. This study evaluate the sleep quality of patients with chronic insomnia by comparing an oral polyherbal formulation, prepared according to Persian medical texts compared to a placebo. Methods: In this randomized controlled trial, an herbal combination called "Monavvem" containing saffron, lettuce, opium poppy, frankincense, agarwood, and sugar was prepared. Fifty-two subjects (61.5% female) with chronic insomnia were randomly assigned to drug or placebo groups who received four capsules every night for 8 weeks. Insomnia Intensity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) questionnaires were completed by all subjects before the onset of the treatment and after 2, 4, and 8 weeks. Results: After intervention, the mean total ISI score was statistically significantly different between the intervention group and placebo group on week (MD: -4.711, 95% CI (-7.150, -2.270)). Also, the intervention group exhibited a decrease in the mean total PSQI score, which was significantly different from the placebo at the end of the study (MD: -3.692, 95% CI (-5.553, -1.831)). Besides, the differences between the intervention group and placebo group scores were statistically significant for the subjective sleep quality, sleep latency, sleep duration, and daytime dysfunction (P< 0.05). No important differences in adverse effects were observed between the two groups. Conclusions: The present findings suggest that the oral polyherbal formulation of Persian medicine "Monavvem" may improve chronic insomnia. Further confirmation in larger trials is recommended.