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0.5 mg fast-release taken one hour before the desired bedtime, alongside behavioural sleep-wake scheduling in both arms. Sleep onset moved 34 minutes earlier (95% CI −60 to −8) and 52.8% improved on clinician rating vs 24.0% on placebo. The scheduling was part of the treatment — this is not a melatonin-alone result.
Educational only — not medical advice. Disclaimer.
NIH DSLD market slice
Bulk CSV dump 16 January 2026 · label entries through 2025. Disclosed amounts only — proprietary blends without gram weights excluded.
Trial floors
Primary
Delayed sleep-wake phase disorder, 0.5 mg timed · 0.5 mg over 4 weeks · Benefit shown — 0.5 mg fast-release taken one hour before the desired bedtime, alongside behavioural sleep-wake scheduling in both arms. Sleep onset moved 34 minutes earlier (95% CI −60 to −8) and 52.8% improved on clinician rating vs 24.0% on placebo. The scheduling was part of the treatment — this is not a melatonin-alone result.
Secondary
Circadian phase advance, timing over dose · 0.3–3 mg over 4 weeks · Benefit shown — 0.3 mg and 3.0 mg advanced circadian phase by the same amount. What predicted the size of the shift was when the dose was taken relative to dim-light melatonin onset (r² = 0.94), not how much was taken. Thirteen subjects.
Label reading notes
- This is the one registry entry where the market problem is overshooting, not undershooting — trial doses are 0.3-0.5 mg while retail gummies commonly carry 5-10 mg.
- Melatonin here entrains circadian timing. A 10 mg gummy at bedtime mainly sedates; 0.3–0.5 mg taken hours before dim-light melatonin onset shifts the clock. Timing relative to DLMO predicted the phase shift (r² = 0.94), not milligram count.
- Both trials were in diagnosed delayed sleep-wake phase disorder with measured melatonin onset, not in general insomnia.
