Evidence map›Paper›PMID 26979830›Full record

Trial reportThe international journal of neuropsychopharmacology2016

A Phase II Dose-Ranging Study Evaluating the Efficacy and Safety of the Orexin Receptor Antagonist Filorexant (MK-6096) in Patients with Primary Insomnia.

Kathryn M Connor, Erin Mahoney, Saheeda Jackson, Jill Hutzelmann, Xin Zhao, Nan Jia, Ellen Snyder, Duane Snavely, David Michelson, Thomas Roth and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The international journal of neuropsychopharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01021852 (A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Period Adaptive Crossover Polysomnography Study to Evaluate the Safety and Efficacy of MK-6096 in Patients With Primary Insomnia), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT01021852 phase2completednot on this map

A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Period Adaptive Crossover Polysomnography Study to Evaluate the Safety and Efficacy of MK-6096 in Patients With Primary Insomnia

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2009 to 2011Enrolled326ConditionsPrimary InsomniaArmsMK-6096, Dose-matched Placebo to MK-6096
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Hypocretin/Orexin Receptor Pharmacology and Sleep Phases.Frontiers of neurology and neuroscience · 2021
    Review
  12. Review
  13. Review
  14. Article
  15. Review
  16. An Update on Dual Orexin Receptor Antagonists and Their Potential Role in Insomnia Therapeutics.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2018
    Review
  17. Orexins, Sleep, and Blood Pressure.Current hypertension reports · 2018
    Review
  18. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Kathryn M ConnorMerck & Co., Inc., Kenilworth, NJ (Dr Connor, Ms Mahoney, Ms Jackson, Ms Hutzelmann, Dr Zhao, Dr Jia, Dr Snyder, Mr Snavely, Dr Michelson, and Dr Herring); Henry Ford Hospital, Detroit, MI (Dr Roth).Current affiliations: Biogen, Cambridge, MA (E.M.). Janssen Pharmaceutical Research and Development, Raritan, NJ (X.Z.). Eli Lilly and Company, Indianapolis, IN (N.J.) kathryn.connor@merck.com.
Erin MahoneyMerck & Co., Inc., Kenilworth, NJ (Dr Connor, Ms Mahoney, Ms Jackson, Ms Hutzelmann, Dr Zhao, Dr Jia, Dr Snyder, Mr Snavely, Dr Michelson, and Dr Herring); Henry Ford Hospital, Detroit, MI (Dr Roth).Current affiliations: Biogen, Cambridge, MA (E.M.). Janssen Pharmaceutical Research and Development, Raritan, NJ (X.Z.). Eli Lilly and Company, Indianapolis, IN (N.J.).
Saheeda JacksonMerck & Co., Inc., Kenilworth, NJ (Dr Connor, Ms Mahoney, Ms Jackson, Ms Hutzelmann, Dr Zhao, Dr Jia, Dr Snyder, Mr Snavely, Dr Michelson, and Dr Herring); Henry Ford Hospital, Detroit, MI (Dr Roth).Current affiliations: Biogen, Cambridge, MA (E.M.). Janssen Pharmaceutical Research and Development, Raritan, NJ (X.Z.). Eli Lilly and Company, Indianapolis, IN (N.J.).
Jill HutzelmannMerck & Co., Inc., Kenilworth, NJ (Dr Connor, Ms Mahoney, Ms Jackson, Ms Hutzelmann, Dr Zhao, Dr Jia, Dr Snyder, Mr Snavely, Dr Michelson, and Dr Herring); Henry Ford Hospital, Detroit, MI (Dr Roth).Current affiliations: Biogen, Cambridge, MA (E.M.). Janssen Pharmaceutical Research and Development, Raritan, NJ (X.Z.). Eli Lilly and Company, Indianapolis, IN (N.J.).
Xin ZhaoMerck & Co., Inc., Kenilworth, NJ (Dr Connor, Ms Mahoney, Ms Jackson, Ms Hutzelmann, Dr Zhao, Dr Jia, Dr Snyder, Mr Snavely, Dr Michelson, and Dr Herring); Henry Ford Hospital, Detroit, MI (Dr Roth).Current affiliations: Biogen, Cambridge, MA (E.M.). Janssen Pharmaceutical Research and Development, Raritan, NJ (X.Z.). Eli Lilly and Company, Indianapolis, IN (N.J.).
Nan JiaMerck & Co., Inc., Kenilworth, NJ (Dr Connor, Ms Mahoney, Ms Jackson, Ms Hutzelmann, Dr Zhao, Dr Jia, Dr Snyder, Mr Snavely, Dr Michelson, and Dr Herring); Henry Ford Hospital, Detroit, MI (Dr Roth).Current affiliations: Biogen, Cambridge, MA (E.M.). Janssen Pharmaceutical Research and Development, Raritan, NJ (X.Z.). Eli Lilly and Company, Indianapolis, IN (N.J.).
Ellen SnyderMerck & Co., Inc., Kenilworth, NJ (Dr Connor, Ms Mahoney, Ms Jackson, Ms Hutzelmann, Dr Zhao, Dr Jia, Dr Snyder, Mr Snavely, Dr Michelson, and Dr Herring); Henry Ford Hospital, Detroit, MI (Dr Roth).Current affiliations: Biogen, Cambridge, MA (E.M.). Janssen Pharmaceutical Research and Development, Raritan, NJ (X.Z.). Eli Lilly and Company, Indianapolis, IN (N.J.).
Duane SnavelyMerck & Co., Inc., Kenilworth, NJ (Dr Connor, Ms Mahoney, Ms Jackson, Ms Hutzelmann, Dr Zhao, Dr Jia, Dr Snyder, Mr Snavely, Dr Michelson, and Dr Herring); Henry Ford Hospital, Detroit, MI (Dr Roth).Current affiliations: Biogen, Cambridge, MA (E.M.). Janssen Pharmaceutical Research and Development, Raritan, NJ (X.Z.). Eli Lilly and Company, Indianapolis, IN (N.J.).
David MichelsonMerck & Co., Inc., Kenilworth, NJ (Dr Connor, Ms Mahoney, Ms Jackson, Ms Hutzelmann, Dr Zhao, Dr Jia, Dr Snyder, Mr Snavely, Dr Michelson, and Dr Herring); Henry Ford Hospital, Detroit, MI (Dr Roth).Current affiliations: Biogen, Cambridge, MA (E.M.). Janssen Pharmaceutical Research and Development, Raritan, NJ (X.Z.). Eli Lilly and Company, Indianapolis, IN (N.J.).
Thomas RothMerck & Co., Inc., Kenilworth, NJ (Dr Connor, Ms Mahoney, Ms Jackson, Ms Hutzelmann, Dr Zhao, Dr Jia, Dr Snyder, Mr Snavely, Dr Michelson, and Dr Herring); Henry Ford Hospital, Detroit, MI (Dr Roth).Current affiliations: Biogen, Cambridge, MA (E.M.). Janssen Pharmaceutical Research and Development, Raritan, NJ (X.Z.). Eli Lilly and Company, Indianapolis, IN (N.J.).
W Joseph HerringMerck & Co., Inc., Kenilworth, NJ (Dr Connor, Ms Mahoney, Ms Jackson, Ms Hutzelmann, Dr Zhao, Dr Jia, Dr Snyder, Mr Snavely, Dr Michelson, and Dr Herring); Henry Ford Hospital, Detroit, MI (Dr Roth).Current affiliations: Biogen, Cambridge, MA (E.M.). Janssen Pharmaceutical Research and Development, Raritan, NJ (X.Z.). Eli Lilly and Company, Indianapolis, IN (N.J.).

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFilorexant (MK-6096) is an orexin receptor antagonist; here, we evaluate the efficacy of filorexant in the treatment of insomnia in adults.

methodsA double-blind, placebo-controlled, randomized, two 4-week-period, adaptive crossover polysomnography study was conducted at 51 sites worldwide. Patients (18 to <65 years) with insomnia received 1 of 4 doses of oral filorexant (2.5, 5, 10, 20mg) once daily at bedtime during one period and matching placebo in the other period in 1 of 8 possible treatment sequences. Polysomnography was performed on night 1 and end of week 4 of each period. The primary endpoint was sleep efficiency at night 1 and end of week 4. Secondary endpoints included wakefulness after persistent sleep onset and latency to onset of persistent sleep.

resultsA total of 324 patients received study treatment, 315 received ≥1 dose of placebo, and 318 ≥1 dose of filorexant (2.5mg, n=79; 5mg, n=78; 10mg, n=80; 20mg, n=81). All filorexant doses (2.5/5/10/20mg) were significantly superior to placebo in improving sleep among patients with insomnia as measured by sleep efficiency and wakefulness after persistent sleep onset on night 1 and end of week 4. The 2 higher filorexant doses (10/20mg) were also significantly more effective than placebo in improving sleep onset as measured by latency to onset of persistent sleep at night 1 and end of week 4. Filorexant was generally well tolerated.

conclusionsOrexin receptor antagonism by filorexant significantly improved sleep efficiency in nonelderly patients with insomnia. Dose-related improvements in sleep onset and maintenance outcomes were also observed with filorexant.

Indexed as

AdolescentAdultCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMaleMiddle AgedOrexin Receptor AntagonistsPiperidinesPolysomnographyPyrimidinesSleep Initiation and Maintenance DisordersTreatment OutcomeYoung AdultMK-6096Orexin Receptor AntagonistsPiperidinesPyrimidinesdose-ranging studyfilorexantinsomniaorexin receptor antagonistsleep efficiency

Identifiers

PMID26979830
PMCPMC5006195

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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.