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
The authors reported no difference 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, they reported a shorter time to fall asleep on palmitoylethanolamide at weeks 4 and 8. They also reported better scores for time to feel fully awake 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.