- Relaxium®: a novel formulation of various herbs and known sleep inducers has been developed.
- Key ingredients include melatonin, L-tryptophan, gamma-aminobutyric acid (GABA) and several herbal extracts (e.g. Sensoril® ashwagandha, Valerest®, a blend of hops and valerian, Chamomile Passionﬂower).
- Formulation is proprietary
- Sponsor wanted to provide clinical evidence that Relaxium® Sleep is a bonaﬁde sleep aid
- To investigate the effect of Relaxium® Sleep administered prior to bedtime on sleep parameters, compared to placebo, in subjects with insomnia.
- To assess the safety and tolerability of Relaxium®.
- Double-blind, Randomized, Placebo-controlled Parallel Group Design in subjects with insomnia.
- A 1-week lead-in period with placebo capsules was followed by randomization to either placebo or Relaxium® in Week 2.
- All medication was to be taken about 1 hour before bedtime.
- Leeds Sleep Evaluation Questionnaires on the last 3-4 days of each treatment week.