Study register / Autonomic / Other / Sleep Apnea

Sleep Apnea

4 curated studies · 3 key studies · mechoulam.de

In obstructive sleep apnoea, a controlled phase II trial showed a dose-dependent reduction in nocturnal breathing pauses under dronabinol. Systematic reviews, however, rate the overall evidence as still insufficient for routine use.

Rating scheme

The letter rates the quality of a study, independently of its type. Every study type can receive any grade: a review can be B or C when it is small or weak, and an RCT can be S. The grade is a synthesis of study design, journal authority and clinical bindingness:

S
Highest evidence, large, methodologically first-rate studies or S3 guidelines
A
Strong evidence, solid, meaningful studies with a clear result
B
Moderate evidence, smaller or methodologically limited studies
C
Weak evidence, preliminary, indirect or contradictory findings
D
Lowest evidence, exploratory hints, single cases or expert opinion

Quality profile per study

To the left of each study there is a profile of four features, it shows the differences within a letter class.

Sample size
Number of participants (RCT) or included studies (review).
Blinding
Double-blind, single-blind or open-label.
Effect size
Clear benefit, mixed, no benefit or harm.
Citations / year
Age-adjusted citation frequency.

Key studies

3
  1. 01
    A
    Cannabinoid therapies in the management of sleep disorders: A systematic review of preclinical and clinical studies
    Suraev et al. ·2020 ·Sleep Medicine Reviews
    Read
  2. 02
    A
    Cannabinoids for obstructive sleep apnea: A systematic review.
    Boylan et al. ·2024 ·Pharmacotherapy
    Read
  3. 03
    A
    Pharmacotherapy of Apnea by Cannabimimetic Enhancement, the PACE Clinical Trial: Effects of Dronabinol in Obstructive Sleep Apnea
    Carley et al. ·2018 ·Sleep
    Read

Systematic Reviews and Meta-Analyses

Syntheses of RCT evidence following Cochrane and PRISMA standards.

3
A
Sample size
Blinding
Effect size No benefit
Citations / year
Key study
Suraev et al. ·2020 ·Sleep Medicine Reviews
163 citations

Cannabinoid therapies in the management of sleep disorders: A systematic review of preclinical and clinical studies

Design
Systematic Review
Sample
k = 26 Studien
Key finding

Insufficient evidence for routine clinical use of cannabinoid therapies for sleep disorders due to lack of research and moderate to high risk of bias.

Summary

Systematic review on cannabinoid therapies for sleep disorders, k=26 studies (14 preclinical, 12 clinical). Insufficient evidence for routine clinical use in sleep disorders due to limited study data and moderate to high risk of bias. Promising preliminary evidence for sleep apnea, insomnia, PTSD-associated nightmares, restless legs syndrome, REM sleep behavior disorder and narcolepsy justifies future RCTs. Clear need for larger, rigorous long-term studies on safety and efficacy.

A
Sample size
Blinding
Effect size Mixed
Citations / year
Key study
Boylan et al. ·2024 ·Pharmacotherapy
3 citations

Cannabinoids for obstructive sleep apnea: A systematic review.

Design
Systematic Review
Sample
k = 9 Studien
Key finding

Eight of nine studies showed statistically significant positive effects on OSA markers (reduced apnea-hypopnea index, improved daytime sleepiness), but 70–80% of participants reported neuropsychiatric and gastrointestinal side effects.

Summary

Systematic review on cannabinoids in obstructive sleep apnea, k=9 studies (5 full text, 4 abstracts) from 170 screened records. Seven experimental studies (predominantly dronabinol), two observational studies (cannabis). Median therapy duration 3 weeks (range 1-6 weeks). Eight of nine studies report statistically significant positive OSA outcomes: AHI reduction and improvement of daytime sleepiness. 70-80% of participants report neuropsychiatric and gastrointestinal adverse events. Quality Appraisal: 2 studies low risk, 1 some concerns, 2 high risk of bias.

A
Sample size
Blinding
Effect size
Citations / year
Mauries et al. ·2026 ·Sleep medicine reviews

Sleep apnea and substance use: a meta-analysis.

Design
Meta-Analyse
Sample
k = 28 Studien
Summary

Meta-analysis on substance use and sleep apnea, k=28 studies from 3784 screening hits. Higher AHI in alcohol users (SMD: 0,46, 95% CI [0,21-0,71], z=3,62, p<0.001) and increased central sleep apnea prevalence in opioid users (SMD: 0,44, 95% CI [0,24-0,64], z=4,37, p<0.001). Only one study on cannabis users vs. non-users identified. Sex and age as potential moderators.

Randomised Controlled Trials

Efficacy and safety evidence from controlled interventional trials.

1
A
Sample size
Blinding Double-blind
Effect size Clear benefit
Citations / year
Key study
Carley et al. ·2018 ·Sleep
135 citations

Pharmacotherapy of Apnea by Cannabimimetic Enhancement, the PACE Clinical Trial: Effects of Dronabinol in Obstructive Sleep Apnea

Design
RCT
Sample
n = 73 Pat.
Key finding

Dronabinol reduced the apnea-hypopnea index (AHI) dose-dependently and improved self-reported sleepiness (ESS) compared with placebo.

Summary

Phase II RCT (PACE Trial), n=73 adults with moderate/severe OSA, dronabinol 2,5 mg vs. 10 mg vs. placebo over 6 weeks. Dose-dependent AHI reduction: 2,5 mg -10,7±4,4 events/h (p=0.02), 10 mg -12,9±4,3 events/h (p=0.003) vs. placebo. Epworth Sleepiness Scale at 10 mg: -3,8±0,8 points (p<0.0001), -2,3±1,2 vs. placebo (p=0.05). Highest treatment satisfaction at 10 mg (p=0.04). No significant changes in sleep architecture or oxygenation.

Ongoing and upcoming studies

Ongoing studies are still in the trial phase and are not evidence of efficacy or safety. The information serves educational purposes only.

3
  • NCT06477952 ClinicalTrials.gov DRonabinol Treatment of OSA Recruiting Phase 1 Start: 2025-08
  • NCT07570953 ClinicalTrials.gov A Study Of Synthetic THC And Sleep Planned Phase 2 Start: 2026-09
  • NCT07635563 ClinicalTrials.gov DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea. Recruiting Phase 2 Start: 2026-07