Double-blind, randomised controlled study. 350mg Levagen®+ (2 x 175mg PEA) taken orally with water one hour prior to sleep onset sleep quality and quantity as measured by the Pittsburgh Sleep Quality Index (PSQI) and wrist actigraphy. The PSQI completed at baseline, day 5, 2 weeks, 4 weeks, at supplementation completion (8 weeks) and at study completion Week 10.

The dose was 350 mg Levagen+ [Label Claim containing NLT 300 mg Palmitoylethanolamide], one hour prior to sleep onset.

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Results

• Levagen®+ significantly reduced the time taken to sleep at night. The Levagen+ group reduced the time to get to sleep compared to placebo with statistically significant differences (p<0.05) measured from week 2 (10 minutes) continuing to reduce significantly at week 4 and 8 (16 and 19 minutes respectively) Figure 1.

• The amount of time to feel awake in the morning (sleep inertia) was statistically significant between the Levagen+ group and placebo group [ p<0.05], with a decrease in time of approximately 11 minutes. So, the active group on Levagen+ woke up fresh in the morning, feeling fully awake faster.

• The Levagen®+ group had improved cognitive function on waking. This was statistically significant between active and placebo [p<0.05].

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Palmitoylethanolamide for sleep disturbance. A double-blind, randomised, placebo-controlled interventional study. Amanda Rao, Phillippa Ebelt, Alistair Mallard & David Briskey