The fixed valerian-hops extract combination Ze 91019 is used as a sleep aid. For this
combination pharmacodynamic actions [1, 2] as well as efficacy has been demonstrated
in patients suffering from sleep problems [3]. While the main focus of research has
been on valerian or the extract combination as a single active entity less is known
about the contributions of hops to the sleep inducing effect of the combination. In
this report, sleep onset latency (SL2) of the combination Ze 91019 was tested in comparison
to valerian extract using a mobile device to allow for recording of sleep parameters
at home while participating in the trial. Patients suffering from sleep disorders
(ICD10: F 51.0, F 51.2) were enrolled when SL2 was prolonged at baseline (≥30min,
inclusion criteria). The hypnograms to calculate the objective sleep parameters were
recorded with a mobile device (QUISI) twice before including the patient into the
study. Treatment period lasted for 4 weeks with placebo, valerian extract (500mg)
or the valerian-hops-extract combination (500mg plus 120mg). Both of the extracts
were prepared with 45% methanol m/m with a DER for valerian: 5–8:1 and for hops 7–10:1.
The results of this trial clearly indicate that hops added to the clinical efficacy
as Ze 91019 was superior to placebo in reducing the originally prolonged sleep onset
latency.
References: 1. Vonderheid-Guth, B. et al. (2000), Eur. J. Med. Res. 5: 139–144. 2. Schellenberg, R. et al. (2004), Planta Med. 70: 595–597. 3. Füssel, A. et al. (2000), Eur. J. Med. Res. 5: 385–389.
