Lemborexant (Dayvigo)
Human insomnia trials studying sleep onset and overnight wakefulness.
Open compound profile →Featured compound: Lemborexant (Dayvigo). Compare source-linked research on Dayvigo, melatonin, Ambien and other sleep medicines.
Human insomnia trials studying sleep onset and overnight wakefulness.
Open compound profile →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.
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 ↗
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.
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.
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.
These findings apply to the population and methods described above.
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.
Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.
SUNRISE 2 analyzed 949 treated adults with insomnia, comparing oral lemborexant 5 or 10 mg with placebo over six months.
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.
This supports sustained improvement in patient-reported insomnia outcomes during the controlled period.
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.
Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.
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.
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.
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.
These results apply to the studied population, formulation and follow-up.
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.
Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.
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.
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.
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.
These results apply to the studied population, formulation and follow-up.
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.
Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.
788 adults aged 21–69 with primary insomnia were randomized to eszopiclone 3 mg (593 participants) or placebo (195) nightly for six months.
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.
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.
These results apply to the studied population, formulation and follow-up.
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.
Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.
451 adults with chronic primary insomnia were randomized to ramelteon 8 mg or placebo, 30 minutes before bedtime nightly for six months.
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.
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.
These results apply to the studied population, formulation and follow-up.
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.
Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.
240 older adults with chronic primary insomnia were randomized to doxepin 1 mg (77), 3 mg (82), or placebo (81) nightly for 12 weeks.
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.
Older adults with primary insomnia, followed for 12 weeks. Results do not establish safety of higher doses or exclude uncommon adverse events.
These results apply to the studied population, formulation and follow-up.
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.
Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.
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.
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.
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.
These results apply to the studied population, formulation and follow-up.
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.
Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.
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.
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.
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.
These results apply to the studied population, formulation and follow-up.
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.
Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.