Trial reportSleep2021
Treating insomnia symptoms with medicinal cannabis: a randomized, crossover trial of the efficacy of a cannabinoid medicine compared with placebo.
Trial report in Sleep, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
42 citing papers in PubMed.
- Cannabinol for Acute Treatment of Insomnia Disorder in a Randomized Placebo-Controlled Crossover Trial.Journal of sleep research · 2026Trial
- Acute Effects of Oral Cannabinoids on Sleep and High-Density EEG in Insomnia: A Pilot Randomised Controlled Trial.Journal of sleep research · 2026Trial
- Trial
- Trial
- Cannabidiol for moderate-severe insomnia: a randomized controlled pilot trial of 150 mg of nightly dosing.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2024Trial
- Trial
- Cannabis use and sleep quality in daily life: An electronic daily diary study of adults starting cannabis for health concerns.Drug and alcohol dependence · 2023Trial
- UK Medical Cannabis Registry: A Clinical Outcomes Analysis for Autism Spectrum Disorder.Neuropsychopharmacology reports · 2026Observational
- Associations of cannabis, alcohol, and tobacco use combinations with sleep health.Addictive behaviors reports · 2026Article
- Article
- Phase II randomized controlled trial comparing traditional Thai cannabis-based medicine with lorazepam for insomnia treatment.Journal of cannabis research · 2026Article
- Cannabinoid Therapies in Less-Common Disorders: Clinical Evidence and Formulation Strategies.Diseases (Basel, Switzerland) · 2026Review
- UK Medical Cannabis Registry: An Updated Analysis of Inflammatory Arthritis.Clinical medicine insights. Arthritis and musculoskeletal disorders · 2026Article
- Changes in sleep quality during the 12 months following medical cannabis initiation.Journal of cannabis research · 2025Article
- Efficacy of Cannabis Oil in Improving Subjective Sleep Quality in Systemic Sclerosis: A Prospective Placebo-Controlled Study.Life (Basel, Switzerland) · 2025Article
- Medical cannabis for the treatment of insomnia.The Cochrane database of systematic reviews · 2025Article
- Sleep, psychological symptoms, and cannabis use before, during, and after COVID-19 "stay-at-home" orders: a structural equation modeling approach.Journal of cannabis research · 2025Article
- A sleepy cannabis constituent: cannabinol and its active metabolite influence sleep architecture in rats.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2025Article
- The driving-related attitudes, beliefs and behaviours of cannabis users in the Australian Capital Territory following decriminalisation.Drug and alcohol review · 2025Article
- UK medical cannabis registry: A clinical outcome analysis of medical cannabis therapy in chronic pain patients with and without co-morbid sleep impairment.Pain practice : the official journal of World Institute of Pain · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
objectivesThis randomized, double-blind, placebo-controlled, crossover study was conducted to evaluate the safety and efficacy of 2 weeks of nightly sublingual cannabinoid extract (ZTL-101) in treating chronic insomnia (symptoms ≥3 months).
methodsCo-primary study endpoints were safety of the medication based on adverse event reporting and global insomnia symptoms (Insomnia Severity Index [ISI]). Secondary endpoints included: self-reported (sleep diary), actigraphy-derived, and polysomnography measurements of sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), sleep efficiency (SE); and self-reported assessments of sleep quality (sSQ) and feeling rested upon waking. Adjusted mean differences between placebo and ZTL-101 were calculated.
resultsTwenty-three of 24 randomized participants (n = 20 female, mean age 53 ± 9 years) completed the protocol. No serious adverse events were reported. Forty mild, nonserious, adverse events were reported (36 during ZTL-101) with all but one resolving overnight or soon after waking. Compared to placebo, ZTL-101 decreased ISI (-5.07 units [95% CI: -7.28 to -2.86]; p = 0.0001) and self-reported SOL (-8.45 min [95% CI: -16.33 to -0.57]; p = 0.04) and increased self-reported TST (64.6 min [95% CI: 41.70 to 87.46]; p < 0.0001), sSQ (0.74 units [95% CI: 0.51 to 0.97]; p < 0.0001), and feeling of being rested on waking (0.51 units [95% CI: 0.24 to 0.78]; p = 0.0007). ZTL-101 also decreased actigraphy-derived WASO (-10.2 min [95% CI: -16.2 to -4.2]; p = 0.002), and increased actigraphy-derived TST (33.4 min [95% CI: 23.07 to 43.76]; p < 0.001) and SE (2.9% [95% CI: 2.0 to 3.8]; p = 0.005).
conclusionsTwo weeks of nightly sublingual administration of a cannabinoid extract (ZTL-101) is well tolerated and improves insomnia symptoms and sleep quality in individuals with chronic insomnia symptoms. CLINICAL TRIAL: ANZCTR; anzctr.org.au; ACTRN12618000078257.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.