Trial reportSleep2020
Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from the phase 3 randomized clinical trial SUNRISE 2.
Trial report in Sleep, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 94 papers, 11 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Long-Term Multicenter, Randomized, Double-Blind, Controlled, Parallel Group Study of the Safety and Efficacy of Lemborexant in Subjects With Insomnia Disorder (SUNRISE 2)
Safety and Efficacy of Lemborexant for Patients With Cirrhosis and Sleep Problems: a Randomized Clinical Trial
Who cites it
94 citing papers in PubMed, 11 syntheses or guidelines pooled it, 158 citations in OpenAlex.
- Vornorexant versus lemborexant for insomnia disorder: a systematic review and network meta-analysis.The international journal of neuropsychopharmacology · 2026Pooled it
- Long-term use of dual orexin receptor antagonists for the treatment of insomnia: a systematic review and meta-analysis.Arquivos de neuro-psiquiatria · 2026Pooled it
- Efficacy and safety of lemborexant vs placebo in treating adults with insomnia disorder: a systematic review and meta-analysis of 1976 patients.Naunyn-Schmiedeberg's archives of pharmacology · 2025Pooled it
- Comparison of efficacy and safety of dual orexin receptor antagonists lemborexant and daridorexant for the treatment of insomnia: a systematic review and meta-analysis.Psychopharmacology · 2025Pooled it
- Comparative efficacy and safety of daridorexant, lemborexant, and suvorexant for insomnia: a systematic review and network meta-analysis.Translational psychiatry · 2025Pooled it
- Adverse events of pharmacological interventions for insomnia disorder in adults: a systematic review and network meta-analysis.Frontiers in psychiatry · 2025Pooled it
- Orexin receptor antagonists in the treatment of insomnia associated with psychiatric disorders: a systematic review.Translational psychiatry · 2024Pooled it
- Pooled it
- Dual orexin receptor antagonists for the treatment of insomnia: systematic review and network meta-analysis.Arquivos de neuro-psiquiatria · 2023Pooled it
- Dual orexin receptor antagonists for treatment of insomnia: A systematic review and meta-analysis on randomized, double-blind, placebo-controlled trials of suvorexant and lemborexant.Frontiers in psychiatry · 2022Pooled it
- Comparative efficacy of lemborexant and other insomnia treatments: a network meta-analysis.Journal of managed care & specialty pharmacy · 2021Pooled it
- Clinical Trial: Lemborexant Efficacy and Safety in Liver Cirrhosis-Randomized, Double-Blind, Crossover Clinical Trial.Alimentary pharmacology & therapeutics · 2026Trial
- Respiratory safety of lemborexant in adult and elderly subjects with moderate-to-severe chronic obstructive pulmonary disease.Journal of sleep research · 2025Trial
- Efficacy and safety of lemborexant in subjects with insomnia disorder receiving medications for depression or anxiety symptoms.Neuropsychopharmacology reports · 2025Trial
- The effect of nightly use of 150 mg cannabidiol on daytime neurocognitive performance in primary insomnia: a randomized controlled pilot trial.Psychopharmacology · 2025Trial
- Efficacy and safety of insomnia treatment with lemborexant in older adults: analyses from three clinical trials.Drugs & aging · 2024Trial
- Re-examining the factor structure of the Insomnia Severity Index (ISI) and defining the meaningful within-individual change (MWIC) for subjects with insomnia disorder in two phase III clinical trials of the efficacy of lemborexant.Journal of patient-reported outcomes · 2024Trial
- Efficacy and Safety of Transitioning to Lemborexant from Z-drug, Suvorexant, and Ramelteon in Japanese Insomnia Patients: An Open-label, Multicenter Study.Advances in therapy · 2024Trial
- Assessing the Real-World, Long-Term Impact of Lemborexant on Sleep Quality in a Home-Based Clinical Study.Nature and science of sleep · 2024Trial
- Efficacy and safety of lemborexant in midlife women with insomnia disorder.Menopause (New York, N.Y.) · 2023Trial
34 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 6 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
objectivesTo assess long-term efficacy and safety of lemborexant (LEM), a novel dual orexin receptor antagonist, versus placebo in adults with insomnia disorder.
methodsThis was a 12-month, global, multicenter, randomized, double-blind, parallel-group phase 3 study comprising a 6-month placebo-controlled period (reported here) followed by a 6-month active-treatment-only period (reported separately). A total of 949 participants with insomnia (age ≥18 years) were randomized, received treatment with an oral dose of placebo or LEM (5 mg [LEM5] or 10 mg [LEM10]) and were analyzed. Sleep onset and sleep maintenance endpoints were analyzed from daily electronic sleep diary data. Treatment-emergent adverse events (TEAEs) were monitored throughout the study.
resultsDecreases from baseline in patient-reported (subjective) sleep onset latency and subjective wake after sleep onset, and increases from baseline in subjective sleep efficiency, were significantly greater with LEM5 and LEM10 versus placebo. Significant benefits over placebo were observed at the end of month 6, and at most time points assessed over the 6-month period, indicating long-term sustained efficacy of LEM. A significantly greater percentage of sleep onset responders and sleep maintenance responders were observed with LEM treatment versus placebo. Participants treated with LEM reported a significant improvement in quality of sleep after 6 months versus placebo. The majority of TEAEs were mild or moderate. There was a low rate of serious TEAEs and no deaths.
conclusionsLEM5 and LEM10 provided significant benefit on sleep onset and sleep maintenance in individuals with insomnia disorder versus placebo, and was well tolerated. CLINICAL
trial registrationClinicalTrials.gov, NCT02952820; ClinicalTrialsRegister.eu, EudraCT Number 2015-001463-39.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.