Pharmacodynamics of temazepam in primary insomnia: Assessment of the value of quantitative electroencephalography and saccadic eye movements in predicting improvement of sleep

Abstract

In subjects with primary insomnia the administration of 20 mg oral temazepam results in changes in both the pharmacodynamic measures and in quality of sleep. No individual correlations between the pharmacodynamic measures and quality of sleep were observed. We concluded that the investigated pharmacodynamic measures are of value in the first assessment of clinical efficacy and for the selection of the dose(s) to be investigated in subsequent trials that aim at showing clinical efficacy. However, the conclusive quantification of clinical efficacy should be performed only on the basis of the clinical end point itself.

0395 Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline

“…Tuk 116 found no significant reduction in PSG NOA at 20 mg. One study 117 reported data for subjective NOA at 20 mg (−0.2 awakenings compared to placebo).…”

“…The quality of evidence for both was moderate due to imprecision. At 20 mg, Tuk 116 reported a +5.9% PSG SE versus placebo.…”

“…One investigation 116 evaluated PSG WASO at the 20 mg dosage and reported WASO time which was 28.1 min less than placebo. Of note, the subjects in this study were described as exhibiting "sleep onset insomnia."…”

Electroencephalogram effects of armodafinil: Comparison with behavioral alertness

“…The greatest challenge is that the agreement between EEG parameters and drug effect is not yet clear in many situations . It has been claimed that a better understanding of the clinical meaning of EEG parameters would be obtained if an alternative measure of drug effect were performed in combination with EEG recording .…”

“…8,9 The greatest challenge is that the agreement between EEG parameters and drug effect is not yet clear in many situations. 10 It has been claimed that a better understanding of the clinical meaning of EEG parameters would be obtained if an alternative measure of drug effect were performed in combination with EEG recording. 1 Although it has been noticed more than two decades ago, the number of studies investigating correlations between changes in EEG parameters and well-established measures of specific drug effects is still limited.…”