Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2016
Suvorexant in Patients with Insomnia: Pooled Analyses of Three-Month Data from Phase-3 Randomized Controlled Clinical Trials.
Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2016. 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 37 papers, 2 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 Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of MK-4305 in Patients With Primary Insomnia - Study A
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of MK-4305 in Patients With Primary Insomnia - Study B
Who cites it
37 citing papers in PubMed, 2 syntheses or guidelines pooled it, 80 citations in OpenAlex.
- Different doses of dual orexin receptor antagonists in primary insomnia: a Bayesian network analysis.Frontiers in pharmacology · 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
- Trial
- Lack of Efficacy of Suvorexant in People with Insomnia and Poorly Controlled Type 2 Diabetes.Nature and science of sleep · 2023Trial
- Trial
- Sleep and pain in humans with fibromyalgia and comorbid insomnia: double-blind, crossover study of suvorexant 20 mg versus placebo.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2020Trial
- Polysomnographic assessment of suvorexant in patients with probable Alzheimer's disease dementia and insomnia: a randomized trial.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2020Trial
- Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase 3 Randomized Clinical Trial.JAMA network open · 2019Trial
- Safety, Tolerability, and Pharmacokinetics of Suvorexant: A Randomized Rising-Dose Trial in Healthy Men.Clinical drug investigation · 2018Trial
- Effects of lemborexant on sleep quality and its association with morning alertness: Post hoc analysis of two phase 3 trials.Sleep medicine: X · 2026Article
- Sleep Disorders in Neurodegenerative Diseases: Pathological Correlations and Underlying Mechanisms.Neuroscience bulletin · 2026Review
- Full-Dose Distribution and Age-Dose Concordance of Suvorexant: A Retrospective Drug Utilization Study at a Japanese University Hospital.Pharmacy (Basel, Switzerland) · 2026Article
- Context-Dependent Temporal Changes in Hypnotics Involved in Suicide Attempts.Neuropsychopharmacology reports · 2026Article
- Insomnia and women: exploring vulnerability, impact, and intervention.Sleep & breathing = Schlaf & Atmung · 2026Review
- Article
- Beyond traditional sleeping pills: safety, efficacy and multidisease potential of three approved orexin receptor antagonists.Frontiers in psychiatry · 2026Review
- Pharmacological modulation of hyperarousal in insomnia associated with major depressive disorder: a narrative review of sedating antidepressants and orexin receptor antagonists.Frontiers in psychiatry · 2026Review
- Orexin receptor antagonists attenuate acute stress-induced disruptions in sleep states.Frontiers in neuroscience · 2026Article
- The effect and safety of sleep interventions on suicidal thoughts and behavior - A systematic review and meta-analyses.Sleep medicine: X · 2025Review
- Top Ten Tips Palliative Care Clinicians Should Know About the Psychiatric Manifestations of Nonpsychiatric Serious Illness and Treatments.Journal of palliative medicine · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
objectivesSuvorexant is an orexin receptor antagonist approved for treating insomnia at a maximum dose of 20 mg. Phase-3 trials evaluated two age-adjusted (non-elderly/elderly) dose-regimes of 40/30 mg and 20/15 mg with the primary focus on 40/30 mg. We report here results from pooled analyses of the 20/15 mg dose-regime, which was evaluated as a secondary objective in the trials.
methodsPrespecified analysis of pooled data from two identical randomized, double-blind, placebo-controlled, parallel-group, 3-month trials in non-elderly (18-64 years) and elderly (≥ 65 years) patients with insomnia. Patients were randomized to suvorexant 20/15 mg (non-elderly/elderly), suvorexant 40/30 mg (non-elderly/elderly), or placebo; by design, fewer patients were randomized to 20/15 mg. Efficacy was assessed by self-reported and polysomnography (PSG; subset of patients) sleep maintenance and onset endpoints.
resultsSuvorexant 20/15 mg (N = 493 treated) was effective compared to placebo (N = 767 treated) on patient-reported and PSG sleep maintenance and onset endpoints at Night-1 (PSG endpoints) / Week-1 (subjective endpoints), Month-1 and Month-3, except for effects on PSG sleep onset at Month-3. Suvorexant 20/15 mg was generally well tolerated, with 3% of patients discontinuing due to adverse events over 3 months vs. 5.2% on placebo. Somnolence was the most common adverse event (6.7% vs. 3.3% for placebo). There was no systematic evidence of rebound or withdrawal signs or symptoms when suvorexant was discontinued after 3 months of nightly use.
conclusionsSuvorexant 20/15 mg improved sleep onset and maintenance over 3 months of nightly treatment and was generally safe and well tolerated. CLINICAL
trial registrationClinicalTrials.gov trial registration numbers: NCT01097616, NCT01097629.
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.