Evaluating Efficacy and Safety of CBD TPM Capsules for Use in Insomnia

Inclusion Criteria:

1. Males and females aged 18 years or older at the time of informed consent.

2. Stated willingness to comply with all study procedures and availability for theduration of the study.

3. Provide a signed and dated patient information and consent form (PICF) for thestudy.

4. Met the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)criteria for insomnia disorder, as follows:

• Complained of dissatisfaction with night-time sleep in the form of difficultygetting to sleep, difficulty staying asleep and/or awakening earlier in themorning than desired despite adequate opportunity for sleep.

• Frequency of the complaint ≥3 times per week.

• Duration of complaint ≥3 months.

• Associated with a complaint of daytime impairment.

5. History of subjective Sleep Onset Latency (sSOL) ≥30 minutes on at least 3 nightsper week in the previous 4 weeks AND/OR subjective Wake After Sleep Onset (sWASO) ≥30 minutes on at least 3 nights per week in the previous 4 weeks.

6. Subject reports a regular time spent in bed, either sleeping or trying to sleep isbetween 7-10 hours.

7. Subjects must have clinical insomnia symptoms as classified by an insomnia severityindex (ISI) Score of ≥15.

8. Confirmation of current insomnia symptoms as determined from the Sleep Diarycompleted on at least 7 consecutive mornings (minimum 5 of 7 for eligibility), suchthat sSOL ≥30 minutes on at least 3 of the 7 nights and/or sWASO ≥30 minutes on atleast 3 of the 7 nights.

9. Subject reports a typical bedtime, (defined as the time the subject attempts tosleep), between 21:00 and 01:00, and waketime, (defined as the time the subject gotout of bed for the day), between 05:00 and 10:00.

10. Subject has access to and is able to use a smart phone.

11. Female subjects of childbearing potential must be abstinent or agree to use a highlyeffective method of contraception for 30 days prior to Day 1, during the study, andfor at least 28 days following the last dose of Investigational Product (IP). Agreesto refrain from donating eggs (ova, oocytes) (from Day 1 until 28 days following thelast dose of IP).

12. Male subjects that are not surgically sterile (i.e., vasectomy) must be abstinent oragree to use effective barrier contraception (i.e., condom) from Day 1 and for atleast 28 days following the last dose of IP and agrees to refrain from spermdonation (from Day 1 until 28 days following the last dose of IP).

Exclusion Criteria:

1. Significant insomnia caused during another sleep-wake disorder, includingnarcolepsy, a breathing-related sleep disorder, a circadian rhythm sleep-wakedisorder, a parasomnia, restless leg syndrome, or an exclusionary score on the SleepDisorders Screening Battery, or Epworth Sleepiness Scale score as follows:

• STOP-Bang score ≥5.

• International Restless Legs Scale score ≥16.

• Epworth Sleepiness Scale score >15 (scores of 11-15 required excessive daytimesleepiness to be recorded in subject's medical history).

2. Reports symptoms potentially related to narcolepsy that in the clinical opinion ofthe Investigator indicates the need for referral for a diagnostic evaluation for thepresence of narcolepsy.

3. Reports a history of sleep-related violent behavior, or sleep driving, or any othercomplex sleep-related behavior, e.g., making phone calls, or preparing and eatingfood while asleep.

4. Beck Depression Inventory - (BDI II) score >19 at Screening.

5. Beck Anxiety Inventory >15 at Screening.

6. Habitually napped more than three times per week.

7. Current or recent cannabis use, within 30 days of consent, and throughout the study.

8. Use of any drug known to affect sleep, within 30 days of Screening and throughoutthe study, including:

• Sedatives (e.g. benzodiazepines, zopiclone, eszopiclone, zaleplon, zolpidem,agomelatine, suvorexant, dual orexin receptor antagonists, sodium oxybatemirtazipine (sedating SSRI) and all tricyclic antidepressants,, , sedating Hantihistamines (cyproheptadine, dexchlorpheniramine, promethazine,trimeprazine, doxylamine, diphenhydramine, cyclizine),, antipsychotics,melatonin, valerian).

• Opioids (e.g. morphine, codeine, oxycodone, methadone, buprenorphine, fentanyl,tramadol, tapentadol, hydromorphone).

• Stimulants (e.g. modafinil, methylphenidate, dexamphetamine, phentermine).

9. Have care responsibilities for an infant <1 year of age.

10. Females who are pregnant or lactating.

11. Have excessive caffeine use (>300 mg or ~3 cups of caffeinated beverages a day)that, in the opinion of the Investigator, contributes to the subject's insomnia, andis unwilling to forgo caffeine-containing beverages for the duration of theirparticipation in the study. Any caffeine consumed needs to be prior to 4:00 pm.

12. PI determined excessive history of acute or severe bronchial asthma (excludingchildhood or exercise induced asthma), diagnosed obstructive sleep apnea, hypoxia,hypoxemia, hypercarbia, or other obstructive airway disease or any condition thatmay increase the risk for respiratory depression.

13. History of neurologic conditions such as seizures or convulsive disorders (includingepilepsy), severe head injury or increased intracranial pressure.

14. A calculated creatinine clearance of < 85 mL/minute at Screening according to theequation using Cockcroft and Gault.

15. Liver function tests for alanine transaminase or aspartate aminotransferase > 1.5times the upper limit of normal at Screening.

16. History of clinically significant (in the opinion of the Investigator) othercardiovascular, pulmonary, neurologic or renal disorders or hepatic,gastrointestinal, oral (difficulty swallowing / taking oral medication),hematological, endocrine, or psychiatric impairment/disorders.

17. Use of any over the counter product, or other medicine derived from hemp orcontaining cannabidiol, within 30 days of Screening and for duration of study.

18. Known intolerance, allergy or hypersensitivity reactions to cannabis or cannabinoidproducts (e.g. hemp), and excipients of the IP.

19. Currently taking or have taken drugs that are moderate or strong inhibitors ofCYP3A4 or CYP2C19 within 2 weeks or 5 half-lives, whichever is longer, prior torandomisation.

20. Excessive use of alcohol (i.e. drink more than 2 standard units of alcohol per dayor >8 standard units per week), including positive results for the alcohol breathtest at Screening, Compliance Check, and Run-in/Randomization (Baseline) visits oris unwilling to abstain from alcohol consumption within 3 hours before bedtime forthe duration of their participation in the study.

21. Recreational drug use, including positive results for the urine drugs of abuse testduring at Screening, Compliance Check and Run-in/Randomization (Baseline) visits.

22. Use of any investigational drug or involvement in another clinical trial within 30days of Screening.

23. Use of anti-coagulant drugs such as warfarin or those known to be metabolized byCYP450 enzymes, within 30 days of Screening.

24. Use of treatments for insomnia (e.g. cognitive-behavioral therapy and CentralNervous System-active drugs), within 30 days of Screening.

25. Self-reported or physician diagnosed comorbid nocturia resulting in frequent (>2)need to get out of bed to use the bathroom during the night.

26. Any history of a medical or psychiatric condition that, in the opinion of theInvestigator, may affect the subject's safety or interfere with the studyassessments.

27. Scheduled for major surgery during the study.

28. Shift work, jet lag or trans-meridian travel (three time zones) in the past month,at Screening and while on study.