A Phase 3, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of CBD Capsules in Adults with Sleep Disturbance

INTERVENTION: Participants will be enrolled across 4 parallel treatment arms to receive daily oral doses of Satipharm CBD or placebo for a period of 30 days. Treatment Arm 1 : 0 mg (placebo), Treatment Arm 2: 25 mg, treatment arm 3: 50 mg, treatment arm 4:100 mg. A single daily dose of Satipharm CBD capsules or placebo (2 capsules/dose) will be administered from Day 1 to Day 30 (each participant will receive a total of 30 doses) with an evening meal. Study drug will be self‐administered on a daily basis from Day 1 through to Day 30. Outpatient clinic visits are scheduled for Days 31 (the day following the last dose of study drug), and again on Day 37 (± 2 days) which is the end of study (EOS) visit. Adherence to the intervention will be done via drug accountability and the participants completion of a daily diary. CONDITION: Mental Health ‐ Other mental health disorders Mild sleep disturbance; ; Mild sleep disturbance Neurological ‐ Other neurological disorders PRIMARY OUTCOME: To compare the efficacy of a single dose of Satipharm CBD capsules vs placebo on sleep disturbances utilising ISI questionnaire; ; ; [Sleep disturbance assessed by ISI questionnaire score at Day 15 or Day 31 from baseline, ; ] To compare the efficacy of a single dose of Satipharm CBD capsules vs placebo on sleep disturbances utilising PROMIS Sleep disturbance questionnaire.[Sleep disturbance assessed by PROMIS sleep disturbance questionnaire score at Day 8, Day 15, Day 22 or Day 31 from baseline.] SECONDARY OUTCOME: Exploratory Objective: To compare the efficacy of Satipharm CBD capsules vs placebo on stress levels[Perceived stress score (PSS) questionnaire ‐ PSS scores will be established at baseline (day ; ‐3) and following dosing with study drug at weekly intervals (Days 8, 15, 22) and finally at the end of the treatment period on Day 31.] To compare the efficacy of different dose levels of Satipharm CBD capsules vs placebo on sleep disturbances[Sleep diary data ‐ Participants will be instructed to fill out the diary each morning starting on the morning of Day ‐2 until Day 31 upon waking to record the previous night’s sleep] To assess the safety and tolerability of single daily oral doses of Satipharm CBD capsules ; administered to study subjects over a 30‐day period compared to placebo[Safety endpoints include evaluation of the following safety parameters: ; • Incidence, severity and relationship of AEs (including withdrawals due to safety or ; tolerability reasons). Timepoints: Day 1, Day 2, Day 8, Day 15, Day 22, Day 31 (clinic visit), Day 34, Day 37 (EOS)/ or ETV (clinic visit) ; • Change from baseline in vital signs. Blood pressure and heart rate is assessed using a sphygmomanometer and body temperature by thermometer. Timepoints: Screening, Day 31 (clinic visit), Day 37 (EOS)/ or ETV (clinic visit) ; • Change from baseline in clinical laboratory (haematology and serum chemistry) parameters. Timepoints: Screening, Day 31 (clinic visit), Day 37 (EOS)/ or ETV (clinic visit) ‐ if required ; ; Safety and tolerability will be determined by evaluating physical examination findings, vital signs, clinical laboratory parameters, and AEs. ] Exploratory Objective: : To compare the efficacy of Satipharm CBD capsules vs placebo on pain levels[McGill SF pain questionnaire ‐ The SF‐MPQ will be evaluated at baseline (Day ‐3) and again at the end of the study treatment period on Day 31.] To compare the efficacy of Satipharm CBD capsules vs placebo on patient quality of life utilising patient perception of improvement (PPI).[PPI will be assessed on Day 15 and Day31] To compare the efficacy of Satipharm CBD capsules vs placebo on patient quality of life utilising SF‐36 questionnaire ; [QoL SF‐36 stress scores will be measured at baseline on Day‐3 and again following dosing with study drug on Day 15 and Day 31. ; . ] INCLUSION CRITERIA: 1. Must have given written informed consent before any study‐related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. 2. Male or female, greater or equal to 18 or less than or equal to 75 years of age at the time of screening. 3. Body mass index (BMI) less than or equal to 35.0 kg/m2 at screening. 4. Are experiencing a disturbed sleeping pattern (ISI score greater than or equal to 10) at the time of screening which has been present for a duration of at least 1 month and has any of the following: a. Difficulty falling asleep b. Difficulty maintaining sleep c. Waking earlier than desired d. Current dissatisfaction with sleep patterns 5. Participants must agree to not change current diet or exercise or use other supplements for sleep disturbance for the study period 6. Evidence of adequate hepatic function at screening as defined by AST a