The Efficacy and Safety of CBD-dominant Cannabis Oil on Chronic Insomnia

INTERVENTION: Cannabidiol (CBD) oil (CNR‐SL‐01) ,Placebo Experimental Device,Placebo Comparator Drug The participants received 10 mg of CBD‐optimized cannabis extract (sublingual) in the morning and 1 mg/kg/dose before bed for 4 weeks,The participants received Placebo for 4 weeks CONDITION: Cannabidiol ; CBD‐dominant Cannabis oil ; Chronic insomnia Chronic insomnia ; Cannabidiol ; CBD‐dominant Cannabis oil ; Chronic insomnia PRIMARY OUTCOME: Polysomnography 3 times in total: 1) Before study drug 2) After CBD 3) After Placebo Total sleep time (TST), Sleep efficiency (SE), Wake after sleep onset (WASO), Sleep‐onset latency (SOL), Arousal Index, Number of awakening (NAW), %N1, %N2, %N3, %Rapid Eye Movement (REM) stage,Actigraphy 3 Periods in total: 1) Before study drug 2) After CBD 3) After Placebo Total sleep time (TST), Sleep efficiency (SE), Sleep onset latency (SOL), Sleep fragmentation index (SFI), Number of Awakening (NAW), Light sleep (N1+N2), Deep sleep (N3), REM sleep, Sleep Score,Drug Effects Questionaire (Side‐effect) 3 times in total: 1) Before study drug 2) After CBD 3) After Placebo 4) After CBD (1st Month) 5) After CBD (2nd Month) 6) After CBD (3rd Month) Side‐effect SECONDARY OUTCOME: Subjective measurements 3 times in total: 1) Before study drug 2) After CBD 3) After Placebo 4) After CBD (1st Month) 5) After CBD (2nd Month) 6) After CBD (3rd Month) Epworth sleepiness Scale (ESS) , Pittsburgh sleep quality index, Quality of life (EQ 5D 5L) INCLUSION CRITERIA: 1. Diagnosis of primary insomnia according to the DSM ‐5 by a physician 2. Insomnia Severity Inde X(ISI) score greater than 30 (moderate‐to‐severe clinical insomnia) 3. Insomnia more than 3 times a week and for more than 3 months