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: ( 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.
Compared to Placebo, Relaxium® was Associated with Statistically
Fall Asleep Faster by 140%
Sleep Longer Without Interruption by 266%
Wake Refreshed and Alert by 69%
Improve Concentration by 80%
No adverse events were reported in the study