Evidence map›Paper›PMID 35749758›Full record

Trial reportJournal of clinical psychopharmacology

Abuse Potential of Lemborexant, a Dual Orexin Receptor Antagonist, Compared With Zolpidem and Suvorexant in Recreational Sedative Users.

Ishani Landry, Nancy Hall, Jagadeesh Aluri, Gleb Filippov, Larisa Reyderman, Beatrice Setnik, Jack Henningfield, Margaret Moline

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical psychopharmacology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.5field-weighted citation impact, top 11% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 26 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Emerging and upcoming therapies in insomnia.Translational and clinical pharmacology · 2024
    Article
  11. Article
  12. Review
  13. Article
  14. Comparative efficacy and safety of suvorexant and lemborexant for insomnia treatment.PCN reports : psychiatry and clinical neurosciences · 2023
    Article
  15. Article
  16. Review
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

8 authors at 2 institutions in 2 countries.

Ishani LandryFrom the Formerly Eisai Inc, Nutley, NJ.
Nancy HallEisai Inc, Nutley, NJ.
Jagadeesh AluriEisai Inc, Nutley, NJ.
Gleb FilippovFrom the Formerly Eisai Inc, Nutley, NJ.
Larisa ReydermanEisai Inc, Nutley, NJ.
Beatrice SetnikAltasciences, Laval, Quebec, Canada, and the Department of Pharmacology and Toxicology, University of Toronto, Toronto, Ontario, Canada.
Jack HenningfieldPinney Associates, Bethesda, MD, and The Johns Hopkins University School of Medicine, Baltimore, MD.
Margaret MolineEisai Inc, Nutley, NJ.
Eisai (United States) · USAltasciences (Canada) · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLemborexant (LEM) is a dual orexin receptor antagonist approved for the treatment of insomnia in adults in multiple countries including the the United States, Japan, Canada, Australia and several Asian countries. PROCEDURES: This was a randomized, single-dose, single-center, double-blind, active-control, 6-way crossover study to evaluate LEM abuse potential. The study assessed oral doses of LEM 10 mg (LEM10), 20 mg (LEM20), and 30 mg (LEM30) compared with placebo (PBO), zolpidem (ZOL) immediate release 30 mg, and suvorexant (SUV) 40 mg. Subjects were healthy, nondependent, recreational sedative users able to discriminate/like the effects of both SUV and ZOL from PBO during a qualification phase.

resultsAbuse potential endpoints were analyzed in qualified subjects who received and completed all treatments (n = 32). On the "at this moment" drug-liking visual analog scale (VAS), mean maximum (peak) effect (primary endpoint) values were 78.4, 80.5, and 83.6 for LEM10, LEM20, and LEM30, respectively, which were all significantly greater than PBO (57.8; all P > 0.05) but not different from SUV (76.1) or ZOL (78.3). Similarly, for secondary endpoints overall drug-liking VAS and take-drug-again VAS, mean maximum (peak) effect values for all LEM doses were significantly greater than PBO ( P > 0.05) but not different compared with ZOL or SUV.

conclusionsFor all doses, LEM demonstrated abuse potential versus PBO and appeared to have a similar abuse potential profile to ZOL and SUV in this study population. Lemborexant was well tolerated. Lemborexant has been placed in Schedule IV, the same drug schedule as ZOL and SUV.

Indexed as

Hypnotics and SedativesOrexin Receptor AntagonistsAdultAzepinesCross-Over StudiesDouble-Blind MethodHumansPyridinesPyrimidinesTriazolesZolpidemAzepinesHypnotics and SedativeslemborexantOrexin Receptor AntagonistsPyridinesPyrimidinessuvorexantTriazolesZolpidem

Identifiers

PMID35749758
PMCPMC9257054
OpenAlexW4283459556

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.