Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Insomnia and Anxiety: A Double-blind, Randomized, Placebo-controlled Study

Abstract

Introduction Insomnia is a prevalent sleep disorder that can profoundly impact a person's physical health and mental wellbeing. Most of the currently available drugs for insomnia exert adverse effects. Hence, alternative herbal therapies could be effective in treating insomnia. Ashwagandha, a proven "Rasayana" from ancient Ayurveda is having the required potential to treat insomnia. Objective To determine the efficacy and safety of Ashwagandha root extract in patients with insomnia and anxiety. Methods This was a randomized, double-blind, placebo-controlled study conducted at Prakruti Hospital, Kalwa, Maharashtra, India. A total of 60 patients were randomly divided into two groups: test (n = 40) and placebo (n = 20) in a randomization ratio of 2:1. Test product was a capsule containing highest concentration full-spectrum Ashwagandha root extract 300 mg, and the placebo was an identical capsule containing starch. Both treatments were given twice daily with milk or water for 10 weeks. Sleep actigraphy (Respironics Philips) was used for assessment of sleep onset latency (SOL), total sleep time (TST), sleep efficiency (SE) and wake after sleep onset (WASO). Other assessments were total time in bed (sleep log), mental alertness on rising, sleep quality, Pittsburgh Sleep Quality Index (PSQI), and Hamilton Anxiety Rating Scale (HAM-A) scales. Results Two patients, one from each group, did not complete study and the per-protocol dataset (n = 58) included 29 and 19 patients from test and placebo, respectively. The baseline parameters were similar in the two groups at baseline. The sleep onset latency was improved in both test and placebo at five and 10 weeks. However, the SOL was significantly shorter (p, 0.019) after 10 weeks with test [29.00 (7.14)] compared to placebo [33.94 (7.65)]. Also, significant improvement in SE scores was observed with Ashwagandha which was 75.63 (2.70) for test at the baseline and increased to 83.48 (2.83) after 10 weeks, whereas for placebo the SE scores changed from 75.14

The 4R’s Framework of Nutritional Strategies for Post-Exercise Recovery: A Review with Emphasis on New Generation of Carbohydrates

“…A root extract that warrants special attention is Withania somnifera (most known as ashwagandha) given some research have found ergogenic effects in athletic [ 121 , 122 ] and physically active individuals [ 123 ]. Moreover, the adaptogenic, anti-inflammatory, and antioxidant properties of ashwagandha [ 124 , 125 , 126 ] turns this herbal extract into a potential strategy to optimize recovery and promote exercise-induced adaptations. Although more research is required, dosages are between 300 and 500 mg of aqueous root extract twice per day.…”

Efficacy and Tolerability of Ashwagandha Root Extract in the Elderly for Improvement of General Well-being and Sleep: A Prospective, Randomized, Double-blind, Placebo-controlled Study

“…Scientific reports suggested that Ashwagandha contains sleep-inducing compounds that aid in better sleep in all age groups. We reported a similar impact of Ashwagandha root extract on insomnia and anxiety recently [28]. Equivalent to modern geriatric medicine, "Jara Chikitsa" (Aging treatment) and "Jara Vyadhi" (Agingassociated diseases), remained an important part of the classical Ayurvedic treatment process where Ashwagandha is recommended as one of the most effective solutions [29].…”

Characteristics, Preferences and Health Care Utilization in Patients Using a Dietary Supplement for Improving Sleeping Disturbances: Results from an Explorative Online Survey

“…For some ingredients of the studied dietary supplement, there is little/moderate evidence of a clinical effect in patients with sleeping disorders: the essential amino acid L-tryptophan, which is a precursor of the endogenous melatonin and serotonin synthesis, is often used to treat insomnia and depression, 17 , 18 and sparse evidence suggests that ashwagandha extract can improve insomnia and anxiety. 19 , 20 However, there are no comparative studies reported in the literature, and general transferability of study results is hardly feasible because ingredients and composition of the studied dietary supplements differ.…”