Evidence map›Paper›PMID 25317090›Full record

Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2014

A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance.

Russell P Rosenberg, Steven G Hull, D Alan Lankford, David W Mayleben, David J Seiden, Sandy A Furey, Shyamalie Jayawardena, Thomas Roth

2 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2014. 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 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 20% 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.

NCT04818450 nacompletednot on this mapstarted 2021, after this paper: background citation

Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient.

TypeinterventionalSponsorMahidol UniversityRan2021 to 2022Enrolled60ConditionsSleep Deprivation, Critically IllArmsGabapentin
NCT06800378 phase4completednot on this mapstarted 2024, after this paper: background citation

The Impact of the Sedative-Hypnotic Medication Zolpidem on Performance in Road Cycling

TypeinterventionalSponsorNational Taiwan Normal UniversityRan2024 to 2024Enrolled15ConditionsHealthyArmsZolpidem 10 mg, Placebo
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Effects of the selective orexin-2 receptor antagonist JNJ-48816274 on sleep initiated in the circadian wake maintenance zone: a randomised trial.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2022
    Trial
  3. Trial
  4. Trial
  5. A randomized, double-blind, placebo-controlled, multicenter, 28-day, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2014
    Trial
  6. Review
  7. Rest the brain to learn new gait patterns after stroke.Journal of neuroengineering and rehabilitation · 2024
    Article
  8. Rest the Brain to Learn New Gait Patterns after Stroke.medRxiv : the preprint server for health sciences · 2024
    Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Review
  14. The assessment and management of insomnia: an update.World psychiatry : official journal of the World Psychiatric Association (WPA) · 2019
    Article
  15. Gabapentin for the treatment of alcohol use disorder.Expert opinion on investigational drugs · 2018
    Review
  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 5 institutions in 1 country.

Russell P RosenbergNeurotrials Research Inc., Atlanta, GA.
Steven G HullVince and Associates Clinical Research, Overland Park, KS.
D Alan LankfordSleep Disorders Center of Georgia, Atlanta, GA.
David W MaylebenCommunity Research, Cincinnati, OH.
David J SeidenMiami Research Associates, Miami, FL.
Sandy A FureyPfizer Consumer Healthcare, Pfizer Inc, Madison, NJ.
Shyamalie JayawardenaPfizer Consumer Healthcare, Pfizer Inc, Madison, NJ.
Thomas RothSleep Disorders and Research Center, Henry Ford Health System, Detroit, MI.
Pfizer (United States) · USAltasciences Clinical Research Vince & Associates · USCalifornia Center for Sleep Disorders · USHenry Ford Health System · USNeuroTrials Research (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesTo evaluate the effects of single doses of gabapentin 250 and 500 mg on polysomnographic (PSG) and participant-reported sleep measures in a 5-h phase advance insomnia model.

methodsAdults reporting occasional disturbed sleep received gabapentin 500 mg (n = 125), 250 mg (n = 125), or placebo (n = 127) 30 min prior to bedtime and were in bed from 17:00 to 01:00, ∼5 h before their habitual bedtime. Sleep was assessed by PSG, post-sleep questionnaire, and the Karolinska Sleep Diary (KSD). Next-day residual effects (Digit Symbol Substitution Test [DSST] and Stanford Sleepiness Scale [SSS]) and tolerability were assessed.

resultsDemographics were comparable among groups. Among PSG endpoints, wake after sleep onset (primary endpoint) (135.7 [placebo], 100.7 [250 mg], and 73.2 [500 mg] min) was significantly lower and total sleep time (TST) (311.4, 356.5, and 378.7 min) significantly greater in both gabapentin groups versus placebo. Latency to persistent sleep was not significantly different among groups. Percent slow wave sleep (12.6%, 15.4%, and 17.0%, respectively) was significantly greater and percent stage 1 (15.1%, 11.8%, and 10.8%, respectively) significantly lower relative to placebo. Gabapentin was associated with significantly higher values of KSD Sleep Quality Index and reported TST versus placebo; no other reported outcomes were significant. Neither gabapentin dose produced evidence of next-day residual effects as measured by DSST and SSS. Adverse events were infrequent (< 5%).

conclusionParticipants with occasional disturbed sleep treated with gabapentin showed significantly longer sleep duration and greater depth (versus placebo) in response to a phase advance manipulation known to disrupt sleep maintenance.

Indexed as

AdolescentAdultAgedAged, 80 and overAminesCalcium Channel BlockersCyclohexanecarboxylic AcidsDouble-Blind MethodFemaleGabapentingamma-Aminobutyric AcidHumansMaleMiddle AgedPolysomnographySleep Initiation and Maintenance DisordersAminesCalcium Channel BlockersCyclohexanecarboxylic AcidsGabapentingamma-Aminobutyric AcidGabapentininsomniapolysomnographysleep phase advancetreatment

Identifiers

PMID25317090
PMCPMC4173087
OpenAlexW1996211108

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.