A Clinical Evaluation on Insomnia (Sahr) and Its Management with a Polyherbal Unani Formulation: An Open-Label, Single-Arm Study.

Insomnia (Sahr) is one of the most common sleep disorders worldwide, characterized by difficulty in initiating or maintaining sleep, early morning awakening, or non-restorative sleep despite adequate opportunity for sleep. It leads to significant impairment in daytime functioning, including fatigue, poor concentration, mood disturbances, and reduced quality of life. Epidemiological studies indicate that insomnia affects approximately 10–30% of adults globally, with higher prevalence among women, the elderly, and individuals experiencing stress or comorbid conditions. In India, insomnia has emerged as an important public health concern due to changing lifestyles, psychological stress, and increasing burden of non-communicable diseases. Conventional management includes pharmacological agents such as benzodiazepines, non-benzodiazepine hypnotics, melatonin receptor agonists, and antidepressants, along with non-pharmacological therapies like Cognitive Behavioral Therapy for Insomnia (CBT-I). However, long-term drug therapy is often associated with adverse effects such as dependence, tolerance, cognitive impairment, daytime sedation, and rebound insomnia, highlighting the need for safer, cost-effective, and holistic alternatives.

Unani medicine describes insomnia as Sahar, a disorder of the brain caused by derangement in temperament (Mizaj) and imbalance of humors, particularly dryness affecting cerebral function. Classical Unani literature recommends various dietetic, regimental, and pharmacological interventions, including the use of natural Munawwim (sleep-inducing) and Musakkin (sedative) drugs that restore humoral balance and promote physiological sleep. The present study is designed as an open-label, single-arm clinical trial to evaluate the safety and efficacy of a polyherbal Unani formulation containing Dhaniya (Coriandrum sativum), Khashkhash (Papaver somniferum), Kahu (Lactuca sativa), Badam Sheeren (Prunus amygdalus), Kaddu (Cucurbita pepo), and Misri (Saccharum officinarum), traditionally used for sleep disorders. A total of 30 patients diagnosed with primary insomnia as per ICSD-3 criteria will be enrolled and administered the test formulation orally for 28 days, with weekly follow-up. Efficacy will be assessed using the Insomnia Severity Index (ISI) and Quality of Life Scale, while safety will be evaluated through clinical monitoring and laboratory investigations (CBC, LFT, KFT). The study aims to generate scientific evidence for the effectiveness of this Unani formulation as a safe and holistic therapeutic option in the management of insomnia and to support its integration into contemporary clinical practice.