TY - JOUR
T1 - Effects of prolonged-release melatonin and zolpidem on postural stability in older adults
AU - Otmani, Sarah
AU - Metzger, Deborah
AU - Guichard, Nathalie
AU - Danjou, Philippe
AU - Nir, Tali
AU - Zisapel, Nava
AU - Katz, Amnon
PY - 2012/5
Y1 - 2012/5
N2 - Objectives A prolonged-release formulation of melatonin (PR-M) is indicated for insomnia in patients aged 55years and older. Because hypnotics result in impairments of body sway, it was important to evaluate the effect of 2mg PR-M on postural stability in older adults at night. Methods Twenty-four healthy volunteers (12 women, 12 men, aged 55-64years) completed a randomized, double-blind, single-dose, three-way crossover study of postural stability of PR-M 2mg, zolpidem 10mg (active control) or placebo. Subjects were tested for body sway 30min before, 1.5 and 4h after dosing. Parameters tested were the area of the 95% confidence ellipse enclosing the center of pressure (COP; [A95]) and COP path length. Results Zolpidem significantly increased the A95 (both eyes conditions at all time points) and path length of COP. PR-M had no effect on A95 (both "eyes closed" and "eyes open" conditions at all time points) compared with placebo and increased COP path length by 10% at 4h post-dose in open but not closed eyes condition. No serious adverse events were observed. Conclusions In older adults, evening PR-M intake did not impair postural stability during the night. The postural instability with zolpidem demonstrated assay sensitivity and validated the outcome.
AB - Objectives A prolonged-release formulation of melatonin (PR-M) is indicated for insomnia in patients aged 55years and older. Because hypnotics result in impairments of body sway, it was important to evaluate the effect of 2mg PR-M on postural stability in older adults at night. Methods Twenty-four healthy volunteers (12 women, 12 men, aged 55-64years) completed a randomized, double-blind, single-dose, three-way crossover study of postural stability of PR-M 2mg, zolpidem 10mg (active control) or placebo. Subjects were tested for body sway 30min before, 1.5 and 4h after dosing. Parameters tested were the area of the 95% confidence ellipse enclosing the center of pressure (COP; [A95]) and COP path length. Results Zolpidem significantly increased the A95 (both eyes conditions at all time points) and path length of COP. PR-M had no effect on A95 (both "eyes closed" and "eyes open" conditions at all time points) compared with placebo and increased COP path length by 10% at 4h post-dose in open but not closed eyes condition. No serious adverse events were observed. Conclusions In older adults, evening PR-M intake did not impair postural stability during the night. The postural instability with zolpidem demonstrated assay sensitivity and validated the outcome.
KW - body sway
KW - nighttime awakenings
KW - older adults
KW - prolonged-release melatonin
KW - zolpidem
UR - http://www.scopus.com/inward/record.url?scp=84861187830&partnerID=8YFLogxK
U2 - 10.1002/hup.2219
DO - 10.1002/hup.2219
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AN - SCOPUS:84861187830
SN - 0885-6222
VL - 27
SP - 270
EP - 276
JO - Human Psychopharmacology
JF - Human Psychopharmacology
IS - 3
ER -