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Abstract

Objectives: Sleep-related issues are common in US adults, with 30.5% reporting < 7 hours of sleep per night and 15.4% reporting trouble falling asleep. Sleep health is cited by 22% of supplement users as their reason for use. The purpose of this study was to evaluate self-reported sleep and relaxation outcomes following use of a powdered nighttime supplement containing magnesium, calming herbs, and adaptogens.

Methods: In a decentralized open-label clinical trial, US adults aged 25-59 reporting subclinical sleep issues were randomized to no supplement (control) or nightly AGZ (13 g in water, 60-90 min before bed) for 30 days. Participants completed a 19-item participant experience questionnaire (PEQ); 4-point agreement scale) at days 1, 3, 7, 14, and 30; the Epworth Sleepiness Scale (ESS; 0-24) at days 1, 7, 14, and 30; and Single-Item Sleep Quality Scale (SQS; 0-10) at days 7, 14, and 30. Responders were determined by answering agree/strongly agree on a PEQ item, decreased ESS from day 1, or increased SQS from day 7. Rates were compared by chi-square or Fisher’s exact with Benjamini-Hochberg correction within timepoint; means compared by Welch’s t-test.

Results: Of 331 randomized, 149 (79 AGZ, 70 control; 45 ± 8 y; 70% women) completed all assessments. AGZ responder rates were higher than control on all PEQ items at each timepoint; median between group difference was 31 percentage points (pp) at day 1 and 57 at day 30. At day 30, 91% vs. 27% felt more relaxed before bed. Mean PEQ total (19-76) changed +7.7 vs. -2.5 from day 1 to day 30 [10.2 (95% CI: 6.9,13.4); p

Conclusions: Adults with subclinical sleep issues consuming AGZ nightly reported earlier and more favorable perceptions of evening relaxation, sleep quality, and morning vitality than an untreated control group, with corroborating positive ESS and SQS changes. These findings support further clinical investigation of AGZ and its effects on sleep and relaxation-related outcomes.

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