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Effect of ramelteon on middle-of-the-night balance in older adults with chronic insomnia.
- Source :
-
Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine [J Clin Sleep Med] 2009 Feb 15; Vol. 5 (1), pp. 34-40. - Publication Year :
- 2009
-
Abstract
- Study Objectives: To evaluate the effect of ramelteon on middle-of-the-night balance, mobility, and memory in older insomniacs.<br />Methods: Thirty-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.<br />Results: Ramelteon 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.<br />Conclusion: In older adults, ramelteon did not impair middle-of-the night balance, mobility, or memory relative to placebo.
- Subjects :
- Aged
Cross-Over Studies
Double-Blind Method
Female
Humans
Hypnotics and Sedatives administration & dosage
Indenes administration & dosage
Male
Memory, Short-Term drug effects
Mental Recall drug effects
Motor Activity drug effects
Orientation drug effects
Pyridines administration & dosage
Reaction Time drug effects
Sleep Initiation and Maintenance Disorders psychology
Wakefulness drug effects
Zolpidem
Hypnotics and Sedatives adverse effects
Indenes adverse effects
Postural Balance drug effects
Pyridines adverse effects
Sleep Initiation and Maintenance Disorders drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1550-9389
- Volume :
- 5
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine
- Publication Type :
- Academic Journal
- Accession number :
- 19317379