(P42-38-26) Comparative Efficacy and Safety of Dietary Supplements for Sleep Disorders: Protocol for a Systematic Review and Network Meta-Analysis

Objectives: To systematically compare and rank the efficacy and safety of oral, single-ingredient dietary supplements in adults with sleep disorders to inform evidence-based clinical and policy decision-making.

Methods: This protocol follows the PRISMA-P and PRISMA-NMA guidelines and uses the PICO framework PROSPERO: CRD420261290702. We will search PubMed and Embase for randomized controlled trials enrolling adults (≥18 years) with diagnosed sleep disorders according to ICSD-3 criteria. Eligible interventions include oral, single-ingredient dietary supplements (e.g., melatonin, magnesium), administered for ≥7 days, compared with placebo or other eligible active comparators. Multi-ingredient formulations will be excluded. The primary outcome is change in sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes include Sleep Onset Latency (SOL), Total Sleep Time (TST), Wake After Sleep Onset (WASO), and adverse events. Two reviewers will independently conduct study selection, data extraction, and risk of bias assessment using RoB 2. A random-effects NMA will be performed in R, assuming a common heterogeneity parameter across comparisons. Treatment will be ranked using Surface Under the Cumulative Ranking curve (SUCRA) values. Transitivity assumptions will be examined by assessing the distribution of key effect modifiers (e.g., baseline insomnia severity, age). Inconsistency will be evaluated using node-splitting and design-by-treatment interaction models. The certainty of evidence for each comparison will be assessed using CINeMA, assessing within-study bias, indirectness, imprecision, heterogeneity, incoherence, and publication bias.

Results: Initial database search yields 13,545 records; following duplicate removal, 11,079 studies remain for screening.

Conclusions: This study will provide a comparative hierarchy of dietary supplements for sleep disorders with graded certainty of evidence, addressing critical gaps in current nutritional and sleep-medicine guidelines, providing clinicians and policymakers with evidence-based frameworks for personalized sleep management

Funding Sources: Thailand Science Research and Innovation (TSRI); National Science, Research and Innovation Fund (Thailand); Chulalongkorn University (Second Century Fund and Graduate Scholarship Programme)