Clinical Trial: Cannabis-Based Herbal Formula Matches Lorazepam for Chronic Insomnia Relief

A randomized clinical trial published in the Journal of Cannabis Research found that a traditional Thai cannabis-based multi-herbal formulation was just as effective as lorazepam in improving sleep among patients with chronic insomnia. The study was conducted by researchers from Suan Sunandha Rajabhat University and Mahidol University in Thailand. While the herbal formula is legally recognized in Thailand for therapeutic use and clinical research, clinical data evaluating its impact on insomnia have remained limited until now.

In this Phase II randomized, double-blind, active-controlled non-inferiority trial, 100 participants with chronic insomnia were assigned to receive either the cannabis-based herbal formulation, known as Anti-Pom-Leung Fever medicine, or lorazepam over a four-week period. Sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI), a widely used tool for assessing insomnia severity.

Eighty-two participants completed the trial, with 41 individuals in each treatment group. Both groups experienced significant improvements in sleep quality over the four weeks. By the end of the study, the herbal formulation group had a mean PSQI score of 3.44, compared to 4.78 in the lorazepam group. The mean difference of -1.34 met the study’s predefined criteria for non-inferiority, meaning the herbal treatment performed at least as well as the prescription sleep medication.

Researchers also found a significant improvement in sleep quality over time in both groups, with no meaningful difference in how the treatments performed across the study period. Measures of quality of life and stress improved in both sets of participants.

Importantly, safety outcomes were comparable between the two treatments. No clinically significant adverse effects were reported, and laboratory and clinical assessments indicated that the herbal formulation was well tolerated.

According to the study’s conclusion, the findings support the short-term use of the traditional Thai cannabis-based formula as an alternative option for managing chronic insomnia.