Palmitoylethanolamide for sleep disturbance. A double-blind, randomised, placebo-controlled interventional study
Randomised controlled trialHumans
- Design
- Randomised controlled trial
- Subjects
- 125 adults with sleep disturbance randomised. 103 completed (55 on palmitoylethanolamide, 48 on placebo).
- Dose used in the study
- 350 mg of Levagen+ once a day, one hour before sleep
- Duration
- 8 weeks
- What was measured
- Sleep quality and quantity by wrist actigraphy, a sleep diary and questionnaires including the Pittsburgh Sleep Quality Index; daytime sleepiness and general health
What the authors reported
This randomised, double-blind, placebo-controlled study found:
- No difference emerged between groups in Pittsburgh Sleep Quality Index scores, sleep quantity or sleep quality at week 8; both groups improved by a similar amount.
- In a sub-group who took more than 10 minutes to fall asleep at the start, time to fall asleep was shorter on palmitoylethanolamide at weeks 4 and 8, and scores for time to feel fully awake were better at week 8.
- Two adverse events were reported on palmitoylethanolamide and four on placebo.
Limits of this study
The main sleep quality measures showed no difference from placebo. The sub-group result is exploratory. Participants had self-reported sleep disturbance, not a diagnosed sleep disorder. The authors noted disruption from the COVID-19 pandemic. The funding statement was not visible on the page checked.
Source
doi:10.1186/s41606-021-00065-3
Entry checked against the article page at the publisher (Springer) on 2026-09-21. The dose shown is the dose the researchers used. It is not a recommendation. How to read this page.