Evidence map›Paper›PMID 25317091›Full record

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

A randomized, double-blind, placebo-controlled, multicenter, 28-day, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance.

Sandy A Furey, Steven G Hull, Mark T Leibowitz, Shyamalie Jayawardena, Thomas Roth

Open 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. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
2.6field-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

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. A randomized, double-blind, single-dose, placebo-controlled, multicenter, 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. Article
  7. Review
  8. Article
  9. Review
  10. Review
  11. The assessment and management of insomnia: an update.World psychiatry : official journal of the World Psychiatric Association (WPA) · 2019
    Article
  12. Article
  13. Gabapentin for the treatment of alcohol use disorder.Expert opinion on investigational drugs · 2018
    Review
  14. 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

5 authors at 4 institutions in 1 country.

Sandy A FureyPfizer Consumer Healthcare, Pfizer Inc, Madison, NJ.
Steven G HullVince and Associates Clinical Research, Overland Park, KS.
Mark T LeibowitzCalifornia Clinical Trials, Glendale, CA.
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 · USHenry Ford Health System · USLos Angeles Clinical Trials · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectiveTo evaluate multiple doses of gabapentin 250 mg on polysomnography (PSG) and participant-reported sleep assessments in a 5-h phase advance insomnia model.

methodsAdults reporting occasional disturbed sleep received gabapentin 250 mg (n = 128) or placebo (n = 128). On Days 1 and 28, participants received medication 30 min before bedtime and were in bed from 17:00 to 01:00, ∼5 h before their habitual bedtime. Sleep was assessed by PSG, a post sleep questionnaire, and the Karolinska Sleep Diary. Next-day residual effects and tolerability were evaluated. On Days 2-27, participants took medication at home 30 min before their habitual bedtime.

resultsTreatment-group demographics were comparable. Gabapentin resulted in significantly less PSG wake after sleep onset (WASO) compared with placebo on Day 1 (primary endpoint, mean: 107.0 versus 149.1 min, p ≤ 0.001) and Day 28 (113.6 versus 152.3 min, p = 0.002), and significantly greater total sleep time (TST; Day 1: 347.6 versus 283.9 min; Day 28: 335.3 versus 289.1 min) (p ≤ 0.001). Participant-reported WASO and TST also showed significant treatment effects on both days. Gabapentin was associated with less %stage1 on Day 1, and greater %REM on Day 28, versus placebo. During home use, gabapentin resulted in significantly less participant-reported WASO and higher ratings of sleep quality. Gabapentin was well tolerated (most common adverse events: headache, somnolence) with no evidence of next-day impairment.

conclusionGabapentin 250 mg resulted in greater PSG and participant-reported sleep duration following a 5-h phase advance on Day 1 and Day 28 of use without evidence of next-day impairment, and greater sleep duration during at-home use.

Indexed as

AdolescentAdultAgedAged, 80 and overAminesCalcium Channel BlockersCyclohexanecarboxylic AcidsDose-Response Relationship, DrugDouble-Blind MethodFemaleGabapentingamma-Aminobutyric AcidHumansMaleMiddle AgedPolysomnographyAminesCalcium Channel BlockersCyclohexanecarboxylic AcidsGabapentingamma-Aminobutyric AcidGabapentininsomniapolysomnographysleep phase advancetransient

Identifiers

PMID25317091
PMCPMC4173088
OpenAlexW2320151955

What OpenQuestion holds

Textmetadata
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.