A double-blind randomized placebo-controlled crossover trial was conducted to evaluate the safety, efficacy, and tolerability of medical cannabis oil on adult subjects with insomnia.

The study was completed by 29 people who self-reported having clinical insomnia. Participants were randomly assigned to get administered a placebo or active oil containing 15 mg/ml cannabidiol (CBD) and 10 mg/ml tetrahydrocannabinol (THC) over 2 weeks titrated 0.2-1.5 ml/day. This was followed by a one-week wash-out phase before crossover.

Daily diaries were used to determine tolerability. Saliva midnight melatonin levels, validated questionnaires, such as Insomnia Severity Index, and Fitbit activity/sleep wrist tracker were used to assess the effectiveness.

At the end of the 2-week intervention period, 60% of subjects were no longer categorized as clinical insomniacs, indicating that medicinal cannabis oil had good tolerability and was effective in promoting sleep. Midnight melatonin levels in the active group dramatically enhanced by 30%, whereas they decreased by 20% in the placebo group.

Both the quality of sleep and the time were enhanced by medicinal cannabis oil, with light sleep increasing by 21 minutes each night in comparison to placebo. The active group's total sleep quality increased by around 80% (pPhase 2 = 0.003), incorporating greater daily functioning. Because of the period impact and absence of blinding, observed effects were more obvious in Phase 2.

Within two weeks, people with insomnia who use medicinal cannabis oil, with a THC:CBD ratio of 10:15 along with smaller quantities of other cannabinoids and naturally occurring terpenes, reported improvements in their mood, midnight melatonin levels, quality of life, and sleep.