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Randomized trial · measured the question itself

4-week trial in 97 adults: melatonin cut early waking, not other sleep measures

Xu and colleagues · Sleep medicine · 2020

Original title: Efficacy of melatonin for sleep disturbance in middle-aged primary insomnia: a double-blind, randomised clinical trial.

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What the study found

Mixed

Melatonin cut early wake time by -30.63min (95% CI, -53.92 to -7.34) but did not change sleep latency, sleep efficiency or PSQI score [1.53(95% CI, -0.55 to 3.61); p = 0.504]. No serious side effects.

The study at a glance

Type of study
Randomized trial
Who or what was studied
97 people · middle-aged adults with long-lasting insomnia
What was tested
Melatonin 3 mg fast-release, 1 hour before bed, vs placebo for 4 weeks
What it measured
The question itself: sleep, and safety with long-term use
Daily amount
3 mg a day
How long
4 weeks
Trial registration
ChiCTR-TRC-13003997
Who has a stake
No disclosure in PubMed
No disclosure in PubMed.
Journal
Sleep medicine, 2020
Source
PubMed record 33157425. This page is based on the abstract only.

How much this study counts

  • ✓Randomized: people were put into groups by chance, so the groups start out alike.
  • ✓Compared with a placebo, a dummy treatment.
  • •Medium size: 97 people.
  • –Short: 4 weeks. Longer-term effects are unknown.
  • ✓Measured the question itself: sleep, and safety with long-term use.
  • •The PubMed record has no conflict-of-interest statement.
  • •Summarized from the PubMed abstract only. The full paper may hold details the abstract leaves out.

✓ Strength– Limit• Note

These points come from fixed rules about the type of study, its size and length, what it measured, and who has a stake. Every study on Digestery gets the same rules.

Where this study sits

Each dot is one on-topic paper on this question. Steps near the top answer the question more directly.

↑ Stronger evidence

  1. Trials in people: sleep onset and sleep quality

    8

    2 benefit, 2 mixed, 4 no difference

    ↑ This study is the ringed dot

  2. Trials in people: other measures

    2

    1 benefit, 1 no difference

  3. Trials in people: lab tests or safety

    0

    None among the papers we read.

  4. Population studies

    0

    None among the papers we read.

  5. Blood levels and genes

    0

    None among the papers we read.

↓ Weaker evidence

  • Points to benefit
  • Mixed
  • No difference
  • No direction
  • Points to harm

How it fits with the other research

The short answer to “Does melatonin help you sleep?”

A small effect, clearer in children.

Confidence: low. Based on 20 on-topic papers.

Read the full answer

Of the other 7 papers on the same step: 2 benefit, 1 mixed, 4 no difference. This one found mixed. It differs from most of them.

Other papers on the same step

See all 20 studies on this question

How this page was made

Label

First read of the abstract
Claude Sonnet
Independent second read
Claude Haiku
Differences settled
The reviewer corrected 1 field after reading the abstract. Claude Opus 5.5.
Headline
Claude Sonnet, from the checked study record. A script checked its numbers and wording.
Numbers
Checked against the abstract by a script
“How much this study counts”
Fixed rules, the same for every study
Source check by a person
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