Table S1. Summary of adult PK data for exogenous oral melatonin at 1mg, 3 mg, and 6 mg doses

Subject, sex / Age / Weight, kg / Height, m / Dose, mg / t1/2, h / Tmax, hr / Cmax, pg/mL / AUC0-tlast, pg/mL·h / V/F, mL/kg / Cl/F, mL/hr/kg
1001, F / 28 / 73 / 1.7 / 1 / 0.71 / 0.33 / 2912 / 4153 / 3306 / 3216
3 / 0.56 / 0.17 / 10026 / 9258 / 3558 / 4434
6 / 0.74 / 0.17 / 34305 / 26550 / 3306 / 3102
1002, F / 56 / 79 / 1.7 / 1 / 1.0 / 0.17 / 7949 / 8510 / 2096 / 1399
3 / 0.88 / 0.17 / 25892 / 23893 / 1982 / 1570
6 / 1.5 / 0.50 / 9475 / 30007 / 4903 / 2318
1003, M / 64 / 109 / 1.8 / 1 / 0.73 / 1.0 / 3547 / 7806 / 1205 / 1142
3 / 0.87 / 1.0 / 10827 / 25860 / 1313 / 1051
6 / 1.2 / 2.0 / 13698 / 43641 / 2094 / 1195
1004, M / 36 / 86 / 1.8 / 1 / 0.84 / 0.17 / 5077 / 3744 / 3738 / 3084
3 / 1.3 / 0.17 / 20462 / 12661 / 3701 / 1932
6 / 0.76 / 0.17 / 91922 / 44910 / 1668 / 1524
Mean (SD) / 46 (17) / 87 (16) / 1.8 (0.09) / 1 (n=4) / 0.82 (0.13) / 0.42 (0.40) / 4871 (2244) / 6053 (2453) / 2586 (1154) / 2210 (1092)
3 (n=4) / 0.90 (0.30) / 0.38 (0.42) / 16802 (7695) / 17918 (8194) / 2639 (1178) / 2247 (1502)
6 (n=4) / 1.10 (0.37) / 0.71 (0.87)
) / 37350 (37964) / 36277 (9357) / 2992 (1450) / 2035 (853)

t1/2 = oral half-life; Cmax = maximum concentration of melatonin; Tmax = time to maximum concentration; AUC0-tlast = area under the concentration vs. time curve determined to the last PK sampling time point; V/F = ratio of volume of distribution to bioavailability; Cl/F = ratio of clearance to bioavailability. For oral dosing, WinNonLin does not assume F =100%. The bioavailability of orally dosed melatonin is highly variable between subjects; literature values for F ranging from 0.01 to 0.3 have been reported in adult studies.