EFFECT OF PSYCHEDELIC THERAPIES ON SLEEP IN PSYCHIATRIC DISORDERS: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CLINICAL TRIALS
Background
Disturbances in sleep are implicated in most psychiatric disorders and are a substantial source of disability and distress. As randomized controlled trials (RCTs) of psychedelic therapies for psychiatric disorders expand, the effects of these novel interventions on sleep outcomes are yet to be systematically delineated.
Objective
This systematic review aims to synthesize the current data on changes in sleep outcomes from RCTs involving adults with psychiatric disorders following administration of serotonergic psychedelics or MDMA.
Methods
We systematically searched MEDLINE, EMBASE, Cochrane Central, PsycINFO, WHO ICTRP, Web of Science, and ClinicalTrials.gov for RCTs investigating psychedelics in psychiatric populations (search conducted 18 July 2025). Studies were included if they involved adults with a psychiatric diagnosis being administered a psychedelic (with or without therapy) in an RCT, defined as: psilocybin, lysergic acid diethylamide (LSD), DMT, 5-MeO-DMT, mescaline, or MDMA, with ≥1 sleep outcome at baseline and post-administration (e.g. embedded sleep item/subscale or objective measure).Data requests were sent to authors for outcomes embedded within psychiatric scales when sleep items were not reported in the literature. Effect sizes were calculated as Hedges’ g for change-from-baseline to each study’s primary endpoint; SD(change) used assumed r=0.5, and multiple within-trial sleep outcomes were combined to a single study-level effect assuming within-study correlation (ρ=0.5; sensitivity varied r, ρ). Review followed PRISMA 2020 guidelines and risk of bias was assessed with ROB-2. RESULTS: Seven RCTs (N=233 participants contributed to analysis) administering psilocybin, ayahuasca, and LSD contributed previously unreported sleep outcomes via data sharing. No eligible MDMA, DMT, 5-MeO-DMT, or mescaline RCTs contributed sleep outcome data. All outcomes were reported as embedded sleep items/subscales across 9 parent psychiatric scales rather than dedicated sleep instruments. Random-effects (REML) pooled analysis at each trial’s primary endpoint demonstrated a small improvement in sleep disturbances following psychedelic administration (Hedges g = -0.26, 95% CI -0.49 to -0.02; p=0.031; I^2=17.3%), with negative values indicating improved sleep. Sensitivity analyses were significant in 8/9 r-ρ specifications (non-significant only at r=0.3, ρ=0.7).
Discussion
Serotonergic psychedelics were associated with a small but significant improvement in sleep outcomes. Conclusions are moderated by high clinical and methodological variability across trials and low author response to data requests (7/44, 16%). Future RCTs should include dedicated sleep instruments (e.g., PSQI) to assess sleep outcomes.