Obstetrics & Gynecology · General Practice · 2 h ago
Supplement improved self-reported sleep in short menopause trial
A three-week randomized, double-blind, placebo-controlled trial enrolled 128 perimenopausal and postmenopausal women with sleep disturbance and minimal vasomotor symptoms. A multi-ingredient supplement improved patient-reported sleep outcomes, but longer-term efficacy and safety remain unestablished.
- Trial randomized 128 women with sleep disturbance and minimal vasomotor symptoms.
- Sleep disturbance responder rates were 90.9% versus 45.2%.
- No between-group differences in adverse events were observed.
- Three-week follow-up and subjective outcomes limit interpretation.
A decentralized trial published in Menopause evaluated a neurotransmitter-modulating supplement in 128 healthy perimenopausal and postmenopausal women with moderate-to-severe sleep disturbance and minimal vasomotor symptoms. Participants received placebo or a formulation containing L-theanine, gamma-aminobutyric acid, magnesium, S-adenosyl methionine, and propyl gallate for three weeks. Primary outcomes were changes in PROMIS sleep disturbance and sleep-related impairment T-scores and responder rates; 127 participants completed the trial.
At week 3, the between-group least-squares mean difference in sleep disturbance T-score favored the supplement by −11.1 points (95% CI, −13.6 to −8.6). Sleep disturbance responder rates were 90.9% versus 45.2%. Sleep-related impairment also improved, with a between-group difference of −4.8 points (95% CI, −7.3 to −2.3) and responder rates of 50.8% versus 32.2%. All primary endpoints reached statistical significance by week 2.
Diary-based total sleep time increased by 40.9 minutes with the supplement versus a 14.9-minute decrease with placebo. Sleep efficiency improved by 7.4% versus 3.4%. No between-group differences in adverse events were observed.
The findings suggest short-term benefit for women whose sleep disturbance occurs despite low vasomotor symptom burden. However, outcomes were patient-reported, follow-up lasted only three weeks, and the selected healthy population limits generalizability. The supplied text does not provide supplement doses, responder definitions, or funding disclosures; longer-term efficacy and safety cannot be inferred.
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Menopause: Nonsedating neurotransmitter-modulating supplement for nonvasomotor sleep disturbance in menopause ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.
