Palmitoylethanolamide for sleep disturbance. A double-blind, randomised, placebo-controlled interventional study

Amanda Rao; Phillippa Ebelt; Alistair Mallard; David Briskey

doi:10.1186/s41606-021-00065-3

Palmitoylethanolamide for sleep disturbance. A double-blind, randomised, placebo-controlled interventional study

Sleep Sci Pract. 2021;5(1):12. doi: 10.1186/s41606-021-00065-3. Epub 2021 Sep 10.

Authors

Amanda Rao^{1

2}, Phillippa Ebelt¹, Alistair Mallard³, David Briskey^{1

4}

Affiliations

¹ RDC Clinical, Brisbane, 4006 Australia.
² University of Sydney, School of Medicine, Sydney, Australia.
³ Faculty of Medicine, University of Queensland, Brisbane, Australia.
⁴ School of Human Movement and Nutrition Sciences, University of Queensland, Brisbane, Australia.

Abstract

Background: Sleep is essential for wellbeing, yet sleep disturbance is a common problem linked to a wide range of health conditions. Palmitoylethanolamide (PEA) is an endogenous fatty acid amide proposed to promote better sleep via potential interaction with the endocannabinoid system.

Methods: This double-blind, randomised study on 103 adults compared the efficacy and tolerability of 8 weeks of daily supplemented PEA formulation (350 mg Levagen + ®) to a placebo. Sleep quality and quantity were measured using wrist actigraphy, a sleep diary and questionnaires.

Results: At week 8, PEA supplementation reduced sleep onset latency, time to feel completely awake and improved cognition on waking. After 8 weeks, both groups improved their sleep quality and quantity scores similarly. There was no difference between groups at baseline or week 8 for sleep quantity or quality as measured from actigraphy or sleep diaries.

Conclusion: These findings support PEA as a potential sleeping aid capable of reducing sleep onset time and improving cognition on waking.

Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12618001339246. Registered 9^th August 2018.

Keywords: Levagen; Palmitoylethanolamide; Sleep; Sleep onset.