Abstract

Introduction: Insufficient sleep duration and poor sleep quality may negatively impact health. Valeriana officinalis has been used traditionally to manage sleep-related issues. The objective of the study was to evaluate the effect of V. officinalis Extract (VE) on sleep quality after single dose administration on day 1.
Methods: A randomized, double-blind, placebo-controlled, parallel, 8-week intervention study was conducted to evaluate the effects of VE on sleep. Eighty subjects with sleep related complaints were randomly assigned to VE and placebo groups in 1:1 ratio and were evaluated for effects on sleep parameters like actual sleep time, sleep latency, and sleep efficiency using wrist actigraphy device.
Result: We evaluated data from 37 subjects in VE group and 35 from placebo group out of 80 subjects randomized for the study. The VE group showed a significant increase (p<0.05) in actual sleep time as compared to the placebo group on day 1 of the study. However, single dose administration of VE did not show significant changes on sleep latency and sleep efficiency as compared to placebo.
Conclusion: Our study indicated significant improvement in the actual sleep time after a single dose administration of VE suggesting an acute benefit of valerian on sleep. This acute effect of VE is significant as we have observed additional sleep benefits on further supplementation including day 3 and 8 weeks and thus potentially VE could be an alternative solution for those looking for early sleep benefits as a safe alternative to melatonin.
Trial registration: Clinical trials registry of India: CTRI/2022/05/042818

Keywords:Sleep; Valerian; Sleeproot®; Anxiety; Melatonin

Abbreviations:AASM: American Academy of Sleep Medicine; BAI: Beck Anxiety Inventory; BMI: Body Mass Index; CTRI: Clinical Trials Registry of India; EEG: Electroencephalogram; GABA: Gamma- Aminobutyric Acid; HPLC: High-Performance Liquid Chromatography; PK: Pharmacokinetic; PSQI: Pittsburgh Sleep Quality Index; REM: Rapid Eye Movement; SE: Sleep Efficiency; VE: V. officinalis Extract