Plasma nitrazepam concentrations after an acute intake and their correlation to sedation and serum growth hormone levels.

Concentrations of nitrazepam in plasma were determined by gas chromatography in healthy volunteers after an acute peroral administration of nitrazepam (5 and 10 mg). Placebo tablets were also used, and an assessement of subjective drug effects was made during each medication. In addition serum growth hormone levels were determined. The peak plasma nitrazepam concentration was achieved at 120 minutes (46.9 +/- 3.2 ng/ml, mean +/- S.E.M.) after 5 mg of nitrazepam and at 180 minutes (82.8 +/- 10.5 ng/ml) after the dose of 10 mg. The half-life of nitrazepam in plasma ranged from 16.5 to 48.3 (mean 28.8) hours. A significant positive correlation was seen between the subjective sedative effects and the magnitude of the peak nitrazepam concentrations in plasma. This drug effect was highly significant when the plasma levels of nitrazepam were rising. The subjective sedative effects were more prominent after 10 mg than after 5 mg dose of nitrazepam. The plasma nitrazepam concentration was not significantly correlated with the subjective sedative effect the next morning, 12 hours after the drug intake. Serum growth hormone levels rose significantly during the study both after 5 mg and 10 mg nitrazepam doses (peak levels 16.3 +/- 4.0 and 12.7 +/- 3.1 ng/ml) and were significantly higher than after placebo administration (3.7 +/- 0.7 ng/ml).

RCT Entities:   Population Interventions Outcomes