Evidence map›Paper›PMID 19317379›Full record

Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2009

Effect of ramelteon on middle-of-the-night balance in older adults with chronic insomnia.

Gary Zammit, Sherry Wang-Weigand, Murray Rosenthal, Xuejun Peng

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00568789 (A Study of the Safety of Ramelteon in Elderly Subjects), which is not on this map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
–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.

NCT00568789 phase4completednot on this map

A Study of the Safety of Ramelteon in Elderly Subjects

TypeinterventionalSponsorTakedaRan2006 to 2006Enrolled33ConditionsInsomniaArmsRamelteon, zolpidem and placebo
3 · Its place in the literature

Who cites it

23 citing papers in PubMed.

  1. Trial
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  7. Ramelteon prior to a short evening nap impairs neurobehavioral performance for up to 12 hours after awakening.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2010
    Trial
  8. Article
  9. Review
  10. Article
  11. Review
  12. Article
  13. Article
  14. Review
  15. Insomnia in the Elderly: A Review.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2018
    Review
  16. Review
  17. Middle-of-the-night hypnotic use in a large national health plan.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2013
    Article
  18. Article
  19. Article
  20. 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

4 authors.

Gary ZammitCliniLabs, Inc., 423 West 55th Street, 4th Floor, New York, NY 10019, USA. gzammit@clinilabs.com
Sherry Wang-Weigand
Murray Rosenthal
Xuejun Peng

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesTo evaluate the effect of ramelteon on middle-of-the-night balance, mobility, and memory in older insomniacs.

methodsThirty-three older adults (age > or = 65 years) with insomnia were enrolled in a single-dose, 3-way crossover study of balance after bedtime administration of ramelteon, 8 mg; zolpidem, 10 mg (positive control); or placebo. Subjects were administered study medication 30 minutes before bedtime and were awakened 2 hours after dosing to evaluate balance (Sensory Organization Test), turning speed and stability, memory (immediate and delayed word recall), and adverse events. There was a 4- to 10-day washout between treatments.

resultsRamelteon or zolpidem (positive control) was compared with placebo. There were no differences between placebo and ramelteon on the Sensory Organization Test (p = 0.837), turn time (p = 0.776), or turn sway (p = 0.982). The positive control (zolpidem) did reveal significant impairments on the Sensory Organization Test, turn time, and turn sway (p < 0.001, all). Immediate and delayed memory recall were not significantly different with ramelteon (p = 0.683 and p = 0.650, respectively). Immediate recall declined significantly with zolpidem (p = 0.002). Adverse events were infrequent (ramelteon, n = 7; placebo, n = 7; zolpidem, n = 13); none were serious.

conclusionIn older adults, ramelteon did not impair middle-of-the night balance, mobility, or memory relative to placebo.

Indexed as

AgedCross-Over StudiesDouble-Blind MethodFemaleHumansHypnotics and SedativesIndenesMaleMemory, Short-TermMental RecallMotor ActivityOrientationPostural BalancePyridinesReaction TimeSleep Initiation and Maintenance DisordersHypnotics and SedativesIndenesPyridinesramelteonZolpidem

Identifiers

PMID19317379
PMCPMC2637164

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.