A phase 1 double-blind, placebo-controlled study of zuranolone (SAGE-217) in a phase advance model of insomnia in healthy adults

2022-01-07T20:35:12+00:00January 7th, 2022|

Pharmaceutical companies have used experimental models of transient insomnia to assess the sleep-promoting effects of investigational drugs for over 40 years.  These models have included the “first-night effect” model, a parallel-group design that assessed drug effects when sleep was recorded in normal, healthy subjects who slept in a new or novel environment for the first time, “noise” models, that assessed drug effects when auditory stimuli were presented to the subject during sleep, and “phase advance” models, when normal, healthy subjects were given bedtimes that were 2, 3, 4, 5 or even 12 hours earlier than their habitual bedtimes.  The phase advance model has proven to be one of the most useful models to evaluate hypnotic effects; it is an efficient design that translates to follow-on studies involving patients with insomnia.  The recent article published by Bullock, et. al. 2021 provides yet another example of the utility of the phase advance model to assess sleep effects before studying a hypnotic in patients.  Clinilabs Drug Development Corporation has established this early-phase model as one that provides crucial information to sponsors about the sleep-promoting effects and safety of investigational new drugs.

To read the full publication, visit: https://pubmed.ncbi.nlm.nih.gov/34352138/