PEDEvidence

Sleep & insomnia research

Featured compound: Lemborexant (Dayvigo). Compare source-linked research on Dayvigo, melatonin, Ambien and other sleep medicines.

The doses below describe trial methods, not personal dosing instructions. Sleep duration, next-day function and safety are distinct outcomes; improvement in one does not establish improvement in all.

Sleep study summaries

Explore melatonin and prescription sleep medicines. Dayvigo remains the featured compound; this collection is not an effectiveness ranking.

9 source-linked cards · human research · abstracts reviewed

Doses describe study methods, not personal instructions. Different formulations and patient groups cannot be compared as if these were head-to-head trials. Zolpidem and eszopiclone carry FDA warnings about complex sleep behaviors, including rare serious injuries. Read the FDA safety information ↗

Human

Does Dayvigo help people fall asleep and stay asleep?

1,006 adults aged 55–88 with insomnia. Lemborexant 5 or 10 mg, zolpidem extended release 6.25 mg, or placebo at bedtime for one month.

Demonstrated findings

Both lemborexant doses improved the primary sleep-onset measure versus placebo. Secondary overnight wake time improved by 24.0 and 25.4 minutes versus placebo. Second-half-of-night wake time improved by 6.7 and 8.0 minutes versus zolpidem.

Limitations & adverse findings

One-month trial, predominantly women. No treatment-related serious adverse events were reported; most other events were mild or moderate. These results do not establish benefit in people without insomnia.

What might this mean? · interpretation

These findings apply to the population and methods described above.

What might this mean, and what would change the interpretation?

One-month trial, predominantly women. No treatment-related serious adverse events were reported; most other events were mild or moderate. These results do not establish benefit in people without insomnia.

What would clarify this: Independent replication with clinically meaningful outcomes and longer safety follow-up.

Findings reviewed · abstract

Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.

Human

Does Dayvigo’s sleep benefit persist for six months?

SUNRISE 2 analyzed 949 treated adults with insomnia, comparing oral lemborexant 5 or 10 mg with placebo over six months.

Demonstrated findings

Both doses improved self-reported sleep onset, overnight wakefulness, sleep efficiency and sleep quality versus placebo at month six. Most adverse events were mild or moderate; serious events were uncommon and no deaths occurred.

What might this mean? · interpretation

This supports sustained improvement in patient-reported insomnia outcomes during the controlled period.

What might this mean, and what would change the interpretation?

Sleep diaries were used. The following six months had active treatment only, so this is not a 12-month placebo-controlled comparison.

What would clarify this: Longer controlled follow-up and functional outcomes.

Findings reviewed · abstract

Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.

Human

Melatonin: what did the insomnia trial show?

354 adults aged 55–80 with insomnia were randomized to prolonged-release melatonin 2 mg or placebo, one tablet daily two hours before bedtime for three weeks.

Demonstrated findings

Combined improvement in sleep quality and morning alertness occurred in 26% versus 15%. Reported time to fall asleep fell by 24.3 minutes versus 12.9 minutes with placebo.

Limitations & adverse findings

Short trial in older adults using one formulation. Findings do not establish the effects of immediate-release products, higher doses or treatment in younger people. The abstract does not provide detailed adverse-event rates.

What might this mean? · interpretation

These results apply to the studied population, formulation and follow-up.

What might this mean, and what would change the interpretation?

This is a selected trial summary, not a full literature review or formal quality appraisal.

What would clarify this: Further studies of long-term outcomes and different patient groups.

Findings reviewed · abstract

Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.

Human

Zolpidem: what did the insomnia trial show?

1,018 adults aged 18–64 received zolpidem extended-release 12.5 mg (669 participants) or placebo (349), on three to seven nights weekly for 24 weeks in a randomized, double-blind trial.

Demonstrated findings

At week 12, the primary patient-rated sleep-help outcome was favorable in 89.8% versus 51.4%. Sleep onset and maintenance reports also improved. Common adverse events included headache, anxiety and sleepiness.

Limitations & adverse findings

Patient-reported outcomes in adults under 65; these findings are formulation-specific. The historical trial dose is not a current starting-dose recommendation. Separate FDA warnings address serious complex sleep behaviors.

What might this mean? · interpretation

These results apply to the studied population, formulation and follow-up.

What might this mean, and what would change the interpretation?

This is a selected trial summary, not a full literature review or formal quality appraisal.

What would clarify this: Further studies of long-term outcomes and different patient groups.

Findings reviewed · abstract

Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.

Human

Eszopiclone: what did the insomnia trial show?

788 adults aged 21–69 with primary insomnia were randomized to eszopiclone 3 mg (593 participants) or placebo (195) nightly for six months.

Demonstrated findings

Patient reports of sleep onset, overnight wakefulness, sleep duration and quality improved versus placebo throughout follow-up. Daytime function ratings also improved. Unpleasant taste and headache were the most common adverse events.

Limitations & adverse findings

Outcomes were reported through a voice-response system. No tolerance signal in this trial does not establish freedom from dependence or rare harms. Separate FDA warnings address serious complex sleep behaviors.

What might this mean? · interpretation

These results apply to the studied population, formulation and follow-up.

What might this mean, and what would change the interpretation?

This is a selected trial summary, not a full literature review or formal quality appraisal.

What would clarify this: Further studies of long-term outcomes and different patient groups.

Findings reviewed · abstract

Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.

Human

Ramelteon: what did the insomnia trial show?

451 adults with chronic primary insomnia were randomized to ramelteon 8 mg or placebo, 30 minutes before bedtime nightly for six months.

Demonstrated findings

Laboratory-measured sleep onset improved at every reported treatment assessment. Patient-reported sleep onset improved at week 1, month 1 and month 5, but was not statistically significant at months 3 and 6. Most adverse events were mild or moderate.

Limitations & adverse findings

Objective and subjective findings differed. No next-morning residual effects, rebound or withdrawal were detected in this trial; that does not establish their absence in all users.

What might this mean? · interpretation

These results apply to the studied population, formulation and follow-up.

What might this mean, and what would change the interpretation?

This is a selected trial summary, not a full literature review or formal quality appraisal.

What would clarify this: Further studies of long-term outcomes and different patient groups.

Findings reviewed · abstract

Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.

Human

Doxepin: what did the insomnia trial show?

240 older adults with chronic primary insomnia were randomized to doxepin 1 mg (77), 3 mg (82), or placebo (81) nightly for 12 weeks.

Demonstrated findings

The 3 mg dose improved the primary first-night wake-time-after-sleep-onset endpoint; sleep-maintenance benefits remained at night 85. Some outcomes also improved with 1 mg. Safety profiles were comparable, with no significant next-day residual effects detected.

Limitations & adverse findings

Older adults with primary insomnia, followed for 12 weeks. Results do not establish safety of higher doses or exclude uncommon adverse events.

What might this mean? · interpretation

These results apply to the studied population, formulation and follow-up.

What might this mean, and what would change the interpretation?

This is a selected trial summary, not a full literature review or formal quality appraisal.

What would clarify this: Further studies of long-term outcomes and different patient groups.

Findings reviewed · abstract

Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.

Human

Suvorexant: what did the insomnia trial show?

Two trials randomized 1,021 and 1,019 adults. Nightly suvorexant doses were 20 or 40 mg for ages 18–64 and 15 or 30 mg for ages 65 and older, versus placebo for three months.

Demonstrated findings

The 20/15 mg groups improved reported total sleep time and laboratory overnight wakefulness at all assessed time points. Sleep-onset measures improved at most, but not all, time points. Fewer than 5% discontinued because of adverse events.

Limitations & adverse findings

The trials primarily focused on the higher 40/30 mg groups, with fewer participants assigned to 20/15 mg. These historical study doses are not a prescribing recommendation or a direct comparison with Dayvigo.

What might this mean? · interpretation

These results apply to the studied population, formulation and follow-up.

What might this mean, and what would change the interpretation?

This is a selected trial summary, not a full literature review or formal quality appraisal.

What would clarify this: Further studies of long-term outcomes and different patient groups.

Findings reviewed · abstract

Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.

Human

Daridorexant: what did the insomnia trial show?

Two randomized trials enrolled 930 and 924 adults. Daridorexant 50/25 mg or 25/10 mg, respectively, was compared with placebo each evening for three months.

Demonstrated findings

In trial 1, 50 mg reduced overnight wakefulness by 18.3 minutes and time to persistent sleep by 11.7 minutes versus placebo at month three. Daytime sleepiness, a secondary outcome, also improved. The 10 mg group did not meet the reported efficacy tests; 25 mg did not significantly improve daytime sleepiness.

Limitations & adverse findings

Adverse-event rates were broadly similar; headache and nasopharyngitis were common. One death was judged unrelated to treatment. Three-month, sponsor-funded trials do not establish comparative superiority over other sleep medicines.

What might this mean? · interpretation

These results apply to the studied population, formulation and follow-up.

What might this mean, and what would change the interpretation?

This is a selected trial summary, not a full literature review or formal quality appraisal.

What would clarify this: Further studies of long-term outcomes and different patient groups.

Findings reviewed · abstract

Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.