CBD-Melatonin Compound Improved Sleep, Anxiety, and Pain in Small Pilot Study

A sublingual compound combining 2.5 mg CBD and 1.5 mg melatonin improved sleep quality, reduced anxiety and mood disturbances, and decreased pain over 3 months in 20 patients with sleep disorders.

Palmieri, G et al.·La Clinica terapeutica·2022·Preliminary EvidencePilot Study
RTHC-04125Pilot StudyPreliminary Evidence2022RETHINKTHC RESEARCH DATABASErethinkthc.com/research

Quick Facts

Study Type
Pilot Study
Evidence
Preliminary Evidence
Sample
N=20

What This Study Found

PSQI (sleep quality) and HAM-A (anxiety) scores showed significant improvements. Mood alterations including anxiety, panic, paranoia, and depression were significantly reduced (p<0.03). Pain perception was significantly reduced (p<0.02). Patients reported good general health perceptions.

Key Numbers

20 patients, ages 43-96. Dose: 2.5 mg CBD + 1.5 mg melatonin, 20 sublingual drops. Duration: 3 months. Mood improvements: p<0.03. Pain improvements: p<0.02.

How They Did This

Open-label observational study of 20 patients (ages 43-96) with sleep disorders who took 20 sublingual drops of a CBD-melatonin compound nightly for 3 months. Assessed monthly via direct contact. Used PSQI for sleep and HAM-A for anxiety.

Why This Research Matters

Sleep disorders are extremely common, and many patients seek natural alternatives to prescription sleep medications. If a low-dose CBD-melatonin combination can improve sleep with fewer side effects, it could offer an accessible option.

The Bigger Picture

This is a very preliminary study, but the combination of CBD and melatonin targets multiple sleep-disrupting mechanisms (anxiety, pain, circadian rhythm) simultaneously. The extremely low CBD dose (2.5 mg) is noteworthy, as most CBD studies use much higher doses.

What This Study Doesn't Tell Us

Very small sample (20 patients), open-label design with no placebo control, and described by the authors as "anecdotal" and "compassionate use." The observed improvements could be due to placebo effect, natural improvement, or melatonin alone. No way to separate the effects of CBD from melatonin.

Questions This Raises

  • ?Is 2.5 mg CBD enough to produce meaningful pharmacological effects, or is melatonin doing the heavy lifting?
  • ?Would a placebo-controlled trial confirm these findings?
  • ?How does this combination compare to melatonin alone or CBD alone?

Trust & Context

Key Stat:
2.5 mg CBD + 1.5 mg melatonin improved sleep and reduced anxiety (p<0.03)
Evidence Grade:
Preliminary: very small, open-label, uncontrolled pilot study described as "anecdotal" by the authors.
Study Age:
Published in 2022.
Original Title:
Insomnia treatment: a new multitasking natural compound based on melatonin and cannabis extracts.
Published In:
La Clinica terapeutica, 173(1), 91-96 (2022)
Database ID:
RTHC-04125

Evidence Hierarchy

Meta-Analysis / Systematic Review
Randomized Controlled Trial
Cohort / Case-Control
Cross-Sectional / ObservationalSnapshot without intervening
This study
Case Report / Animal Study

A small preliminary study to test whether a larger study is feasible.

What do these levels mean? →

Frequently Asked Questions

Does CBD help with sleep?

This pilot study found improvements when CBD was combined with melatonin, but without a control group, it is impossible to know whether CBD added benefit beyond melatonin alone. The CBD dose (2.5 mg) was very low compared to most CBD studies.

Is the CBD-melatonin combination safe?

No adverse effects were reported in this small 3-month study. However, with only 20 participants and no formal safety monitoring beyond monthly check-ins, the safety profile needs more rigorous evaluation.

Read More on RethinkTHC

Cite This Study

RTHC-04125·https://rethinkthc.com/research/RTHC-04125

APA

Palmieri, G; Vadalà, M; Corazzari, V; Palmieri, B. (2022). Insomnia treatment: a new multitasking natural compound based on melatonin and cannabis extracts.. La Clinica terapeutica, 173(1), 91-96. https://doi.org/10.7417/CT.2022.2399

MLA

Palmieri, G, et al. "Insomnia treatment: a new multitasking natural compound based on melatonin and cannabis extracts.." La Clinica terapeutica, 2022. https://doi.org/10.7417/CT.2022.2399

RethinkTHC

RethinkTHC Research Database. "Insomnia treatment: a new multitasking natural compound base..." RTHC-04125. Retrieved from https://rethinkthc.com/research/palmieri-2022-insomnia-treatment-a-new

Access the Original Study

Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.

This study breakdown was produced by the RethinkTHC research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.