OBJECTIVES: A prolonged-release formulation of melatonin (PR-M) is indicated for insomnia in patients aged 55 years and older. Because hypnotics result in impairments of body sway, it was important to evaluate the effect of 2 mg PR-M on postural stability in older adults at night. METHODS:Twenty-four healthy volunteers (12 women, 12 men, aged 55-64 years) completed a randomized, double-blind, single-dose, three-way crossover study of postural stability of PR-M 2 mg, zolpidem 10 mg (active control) or placebo. Subjects were tested for body sway 30 min before, 1.5 and 4 h 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 4 h 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.
RCT Entities:
OBJECTIVES: A prolonged-release formulation of melatonin (PR-M) is indicated for insomnia in patients aged 55 years and older. Because hypnotics result in impairments of body sway, it was important to evaluate the effect of 2 mg PR-M on postural stability in older adults at night. METHODS: Twenty-four healthy volunteers (12 women, 12 men, aged 55-64 years) completed a randomized, double-blind, single-dose, three-way crossover study of postural stability of PR-M 2 mg, zolpidem 10 mg (active control) or placebo. Subjects were tested for body sway 30 min before, 1.5 and 4 h 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 4 h 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.
Authors: Annemiek Vermeeren; Hong Sun; Eric F P M Vuurman; Stefan Jongen; Cees J Van Leeuwen; Anita C M Van Oers; John Palcza; Xiadong Li; Tine Laethem; Ingeborg Heirman; An Bautmans; Matthew D Troyer; Rebecca Wrishko; Jacqueline McCrea Journal: Sleep Date: 2015-11-01 Impact factor: 5.849
Authors: Janne Nurminen; Juha Puustinen; Ritva Lähteenmäki; Tero Vahlberg; Alan Lyles; Markku Partinen; Ismo Räihä; Pertti J Neuvonen; Sirkka-Liisa Kivelä Journal: BMC Geriatr Date: 2014-11-21 Impact factor: 3.921
Authors: Laura Palagini; Raffaele Manni; Eugenio Aguglia; Mario Amore; Roberto Brugnoli; Stéphanie Bioulac; Patrice Bourgin; Jean-Arthur Micoulaud Franchi; Paolo Girardi; Luigi Grassi; Régis Lopez; Claudio Mencacci; Giuseppe Plazzi; Julia Maruani; Antonino Minervino; Pierre Philip; Sylvie Royant Parola; Isabelle Poirot; Lino Nobili; Giovanni Biggio; Carmen M Schroder; Pierre A Geoffroy Journal: Front Psychiatry Date: 2021-06-10 Impact factor: 4.157
Authors: Annemiek Vermeeren; Eva Vets; Eric F P M Vuurman; Anita C M Van Oers; Stefan Jongen; Tine Laethem; Ingeborg Heirman; An Bautmans; John Palcza; Xiadong Li; Matthew D Troyer; Rebecca Wrishko; Jacqueline McCrea; Hong Sun Journal: Psychopharmacology (Berl) Date: 2016-07-16 Impact factor: 4.530