Document Detail

Soporific effect of the neurosteroid pregnanolone in relation to the substance's plasma level: a pilot study.
MedLine Citation:
PMID:  8904740     Owner:  NLM     Status:  MEDLINE    
The soporific effect of the neuroactive steroid pregnanolone, a metabolite of progesterone, and its relationship with plasma concentrations was assessed in 18 young, healthy, male volunteers for 2 h after administration of a single dose of pregnanolone prepared in two different formulations. Sedation was measured as sleep propensity and power increase in the low frequency delta band of the quantified EEG, based on 5-min polygraphic (EEG, EOG, EMG) recordings under resting conditions, which were performed immediately before, and 30, 60, 90, and 120 min after intake of the study drug. With both formulations, there was a time-dependent increase in plasma concentration of pregnanolone with highest values 1-2 h postdosing. The model of short polygraphic recordings under resting conditions demonstrated soporific effects of pregnanolone. Compared to predosing baseline the number of sleep attempts and the time asleep increased after treatment with a peak 60 min postdosing. Quantitative EEG analysis revealed an increase of absolute amplitude in the delta frequency range with a comparable temporal pattern. Correlations between the soporific effect and plasma concentrations of pregnanolone suggest that the effects were drug-related, although this has to be replicated with placebo control.
H Schulz; M Jobert; K W Gee; D W Ashbrook
Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Neuropsychobiology     Volume:  34     ISSN:  0302-282X     ISO Abbreviation:  Neuropsychobiology     Publication Date:  1996  
Date Detail:
Created Date:  1997-02-12     Completed Date:  1997-02-12     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  7512895     Medline TA:  Neuropsychobiology     Country:  SWITZERLAND    
Other Details:
Languages:  eng     Pagination:  106-12     Citation Subset:  IM    
PAREXEL GmbH, Independent Pharmaceutical Research Organization, Berlin, Germany.
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MeSH Terms
Electroencephalography / drug effects*
Pregnanolone / metabolism*,  pharmacology*
Sleep / drug effects*
Reg. No./Substance:

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