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GABA and sleep latency: grade C

Limited evidence. Direction: No effect.

C LimitedIndustry-fundedShort-term only

Why this grade

Rubric condition met: Small trials, mostly in poor sleepers or adults with insomnia symptoms; mixed against placebo; not B under the rubric (no double-blind RCT of 100 or more, and the second RCT was not significant against placebo)

A 2020 systematic review of 14 placebo-controlled trials found very limited evidence for sleep benefits. Two single-blind crossover studies in 10 and 16 poor sleepers, run by researchers employed by the supplier Pharma Foods International, reported shorter sleep latency with 100 mg; the second abstract gives no comparison with placebo. In a double-blind trial of 40 adults with insomnia symptoms funded by the supplier Natural Way, 300 mg for 4 weeks shortened sleep latency on polysomnography with a significant group-by-time interaction, but the placebo group had only 10 people and baseline sleep differed between groups. A second trial from the same group (54 adults, 75 mg) found the change was not significant relative to placebo. All four trials were industry-run or industry-funded, and those with a stated length lasted 1 to 4 weeks. Only one small single-blind crossover and one imbalanced double-blind trial were positive against placebo, so the proposal is C with direction none (limited, mixed).

How we grade evidence

Studies this grade rests on

EffectMixedNo effectSize shows participants (n)201520202025Meta-analysisRCTCrossover RCTYoon 2022, 2022: RCT, n = 54, result not recordedByun 2018, 2018: RCT, n = 40, result not recordedYamatsu 2015, 2015: crossover RCT, n = 16, result not recordedYamatsu 2016, 2016: crossover RCT, n = 10, result not recordedHepsomali 2020, 2020: meta-analysis, n not recorded, result not recorded
each study this grade rests on, by publication year and design. Solid: effect versus the comparator; half-filled: mixed; hollow: no effect; dashed: result not recorded yet. Larger marks had more participants.
Show the numbers
StudyYearDesignParticipantsResult
Yamatsu 20152015crossover RCT16result not recorded
Yamatsu 20162016crossover RCT10result not recorded
Byun 20182018RCT40result not recorded
Hepsomali 20202020meta-analysisnot recordedresult not recorded
Yoon 20222022RCT54result not recorded

Efficacy and Safety of Low-Dose Gamma-Aminobutyric Acid From Unpolished Rice Germ as a Health Functional Food for Promoting Sleep: A Randomized, Double-Blind, Placebo-Controlled Trial.

Yoon S, Byun JI, Shin WC. Efficacy and Safety of Low-Dose Gamma-Aminobutyric Acid From Unpolished Rice Germ as a Health Functional Food for Promoting Sleep: A Randomized, Double-Blind, Placebo-Controlled Trial J Clin Neurol, 2022. PMID 35796273

Result not recorded
Design
Randomized, double-blind, placebo-controlled trial (letter)
Sample
n = 54
Population
Adults with insomnia (clinical population)
Funding
Natural Way Co., Ltd, which supplied the GABA

Safety and Efficacy of Gamma-Aminobutyric Acid from Fermented Rice Germ in Patients with Insomnia Symptoms: A Randomized, Double-Blind Trial.

Byun JI, Shin YY, Chung SE. Safety and Efficacy of Gamma-Aminobutyric Acid from Fermented Rice Germ in Patients with Insomnia Symptoms: A Randomized, Double-Blind Trial J Clin Neurol, 2018. PMID 29856155

Result not recorded
Design
Randomized, double-blind, placebo-controlled trial (3:1 allocation)
Sample
n = 40
Population
Adults with insomnia symptoms (clinical population)
Funding
Natural Way Co. Ltd, which supplied the GABA

The Improvement of Sleep by Oral Intake of GABA and Apocynum venetum Leaf Extract.

Yamatsu A, Yamashita Y, Maru I. The Improvement of Sleep by Oral Intake of GABA and Apocynum venetum Leaf Extract J Nutr Sci Vitaminol (Tokyo), 2015. PMID 26052150

Result not recorded
Design
Controlled crossover trial (single-blind per S1)
Sample
n = 16
Population
Adult poor sleepers (PSQI above 6)
Funding
not stated in the PubMed or Crossref record; authors affiliated with Pharma Foods International Co., Ltd.

Effect of oral γ-aminobutyric acid (GABA) administration on sleep and its absorption in humans.

Yamatsu A, Yamashita Y, Pandharipande T. Effect of oral γ-aminobutyric acid (GABA) administration on sleep and its absorption in humans Food Sci Biotechnol, 2016. PMID 30263304

Result not recorded
Design
Randomized, single-blind, placebo-controlled crossover trial
Sample
n = 10
Population
Adult poor sleepers (PSQI above 6)
Funding
not stated in the PubMed or Crossref record; authors affiliated with Pharma Foods International Co., Ltd.

Effects of Oral Gamma-Aminobutyric Acid (GABA) Administration on Stress and Sleep in Humans: A Systematic Review.

Hepsomali P, Groeger JA, Nishihira J. Effects of Oral Gamma-Aminobutyric Acid (GABA) Administration on Stress and Sleep in Humans: A Systematic Review Front Neurosci, 2020. PMID 33041752

Result not recorded
Design
Systematic review of 14 placebo-controlled human trials (no meta-analysis)
Population
Healthy adults and poor sleepers in trials of natural or fermentation-produced oral GABA
Funding
Unilever UK Central Resources Limited paid open-access fees; first author employed by Unilever

Search and history

Search (): gaba[ti] AND (sleep[tiab]) AND (randomized controlled trial[pt] OR clinical trial[pt])

  • Graded C (proposed): Proposed in the monograph draft
  • C to C (approved): Editor sign-off November 13, 2026: grade matches the editor-approved final page