A carefully designed study assessed the short-term (single dose) and long-term (14
days with multiple dosage) effects of a valerian extract on both objective and subjective
sleep parameters. The investigation was performed as a randomised, double-blind, placebo-controlled,
cross-over study. Sixteen patients (4 male, 12 female) with previously established
psychophysiological insomnia (ICSD-code 1.A.1.), and with a median age of 49 (range:
22 to 55), were included in the study. The main inclusion criteria were reported primary
insomnia according to ICSD criteria, which was confirmed by polysomnographic recording,
and the absence of acute diseases. During the study, the patients underwent 8 polysomnographic
recordings: i. e., 2 recordings (baseline and study night) at each time point at which
the short and long-term effects of placebo and valerian were tested. The target variable
of the study was sleep efficiency. Other parameters describing objective sleep structure
were the usual features of sleep-stage analysis, based on the rules of Rechtschaffen and Kales (1968), and the arousal index (scored according to ASDA criteria, 1992) as a sleep
microstructure parameter. Subjective parameters such as sleep quality, morning feeling,
daytime performance, subjectively perceived duration of sleep latency, and sleep period
time were assessed by means of questionnaires. After a single dose of valerian, no
effects on sleep structure and subjective sleep assessment were observed. After multiple-dose
treatment, sleep efficiency showed a significant increase for both the placebo and
the valerian condition in comparison with baseline polysomnography. We confirmed significant
differences between valerian and placebo for parameters describing slow-wave sleep.
In comparison with the placebo, slow-wave sleep latency was reduced after administration
of valerian (21.3 vs. 13.5 min respectively, p < 0.05). The SWS percentage of time
in bed (TIB) was increased after long-term valerian treatment, in comparison to baseline
(9.8 vs. 8.1 % respectively, p < 0.05). At the same time point, a tendency for shorter
subjective sleep latency, as well as a higher correlation coefficient between subjective
and objective sleep latencies, were observed under valerian treatment. Other improvements
in sleep structure - such as an increase in REM percentage and a decrease in NREM1
percentage - took place simultaneously under placebo and valerian treatment. A remarkable
finding of the study was the extremely low number of adverse events during the valerian
treatment periods (3 vs. 18 in the placebo period). In conclusion, treatment with
a herbal extract of radix valerianae demonstrated positive effects on sleep structure
and sleep perception of insomnia patients, and can therefore be recommended for the
treatment of patients with mild psychophysiological insomnia.
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Dr. F. Donath
Institut für Klinische Pharmakologie Universitätsklinikum Charité Humboldt-Universität
zu Berlin
Schumannstraße 20/21
D-10117 Berlin
Germany