PharmExtracta’s lemon balm may reduce insomnia severity

Vitamin-C-may-help-prevent-sleep-disorders.jpg
Pharmextracta’s lemon balm improves sleep © AleksandarNakic / Getty Images (Getty Images)

New research reports that a lemon balm extract formulated for improved bioavailability may improve sleep quality and duration.

Writing in the journal Nutrients, researchers in Italy used the commercial Meloff-branded product by PharmExtracta SpA, formulated with Indena’s branded Relissa (Melissa officinalis Phytosome).

The researchers noted that while Melissa officinalis is known for its potential anti-anxiety and anti-insomnia benefits, effects in humans can vary due to limited bioavailability.

Francesco Di Pierro, who is the scientific director of Pharmextracta, served as lead author on the study. He is also affiliated with the University of Insubria and Velleja Research.

Lemon balm for sleep

Melissa officinalis (MO), commonly called lemon balm, is known for its calming effects. Previous studies have identified that MO contains volatile compounds, triterpenoids, phenolic acids and flavonoids, including hydroxycinnamic acids such as rosmarinic acid.

These compounds interact with acetylcholine-esterase, GABA receptors and MMP2, benefiting conditions like anxiety-related insomnia.

However, rosmarinic acid’s poor bioavailability limits its effectiveness in placebo-controlled human sleep studies.

Sleep is vital for recovery and energy and heavily influences quality of life. Insomnia, often linked to mood and anxiety disorders, correlates with various metabolic disruptions and increased obesity risk.

REM and slow-wave sleep (SWS) phases are key to mental health and cognitive performance. While REM aids mental stability, SWS restores synaptic homeostasis and consolidates learning.

Study details

The prospective, double-blind, placebo-controlled, cross-over study recruited 30 participants (13 males, 17 females) between the ages of 18 and 65 from clinical centers in Italy and provided them all with a Garmin VenuSq device for sleep monitoring.

After receiving two kits identical in appearance—one with active Melissa officinalis Phytosome (MOP) tablets and another with placebo tablets, participants were instructed to take two tablets (MOP or placebo) nightly for two weeks, followed by a seven-day washout before switching treatments for another two weeks.

Di Pierro and colleagues monitored outcomes to assess sleep quality metrics like total sleep duration and REM phase. They also evaluated self-reported insomnia severity (ISI), physical activity (IPAQ) and anxiety (STAI-Y).

Using ISI to evaluate subjective sleep quality, they observed that at baseline, 26.7% of participants reported no insomnia, 60% had subclinical insomnia, and 13.3% experienced moderate insomnia.

After MOP supplementation, ISI scores significantly improved, with participants reporting better sleep quality and duration compared to placebo.

SWS significantly increased, aligning with better daytime functionality, memory consolidation and reduced dementia risk.

The study noted, however, that this increase came at the expense of REM sleep, which the researchers suggested decreased due to the redistribution of sleep phases.

Subjective sleep quality was also assessed using the CGI-I scale. During MOP supplementation, 87% of participants reported improvements, compared to only 30% in the placebo group.

“These findings suggest that MOP may represent a natural and safe alternative to traditional pharmacological treatments for insomnia,” the researchers wrote.

They added that future studies could explore the role of deep sleep in improving cognitive and memory functions while also assessing the long-term effects of Phytosome intake in more diverse populations.

Source: Nutrients
2024, 16(23), 4199; doi: 10.3390/nu16234199
“Effects of Melissa officinalis Phytosome on Sleep Quality: Results of a Prospective, Double-Blind, Placebo-Controlled, and Cross-Over Study”
Authors: Di Pierro, F. et al.