The CANabidiol Use for RElief of Short Term Insomnia

You may not qualify if:

• Serious medical and/or psychiatric illnesses/disorders that will require treatment during the trial period.
• The use of any drug known to affect sleep during the study one week prior the randomization, including:
• Sedatives (benzodiazepines, Z drugs, agomelatine, suvorexant, sodium oxybate, sedating antidepressants, sedating antihistamines, antipsychotics, melatonin, valerian).
• Opioids (e.g. morphine, codeine, oxycodone, methadone, buprenorphine, fentanyl, tramadol, tapentadol, hydromorphone).
• Stimulants (e.g. methylphenidate, dexamphetamine, modafinil, phentermine).
• Excessive caffeine use (defined as \> 600mg caffeine or approximately 6 cups of caffeinated beverages a day) that, in the opinion of the medical doctor, contributes to the participant's insomnia.
• Excessive alcohol use (defined as per NHMRC guideline, i.e. no more than four standard drinks per day on average for men, and for women, no more than two).
• The use of cannabinoids or a cannabinoid-based medicine within 3 months prior to study Day 1 and unwillingness to abstain from recreational drug use during the study period.
• Cannabis dependence or any other drug or alcohol dependence within the past two years.
• Positive urine drug screen (e.g., amphetamines type substances, benzodiazepines, cannabinoids, cocaine, and opiates) at screening or Day -1 or a history of drug abuse within the past 2 years.
• Known hypersensitivity to cannabis-based products or any of the excipients in the study drug.
• Use of any investigational drug or involvement in another clinical trial within 30 days of screening day.
• Use of anti-coagulant drugs such as warfarin or those known to be metabolised by CYP450 enzymes.
• Current or ongoing treatments for insomnia (e.g. cognitive-behavioural therapy (CBT) and CNS-active drugs).
• Obstructive sleep apnoea determined by the MAPI questionnaire or other self-reported sleep disorders.
• +4 more criteria