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

Author(s): Zammit G, Wang-Weigand S, Rosenthal M, Peng X

Affiliation(s): CliniLabs, Inc., 423 West 55th Street, 4th Floor, New York, NY 10019, USA. gzammit@clinilabs.com

Publication date & source: 2009-02-15, J Clin Sleep Med., 5(1):34-40.

Publication type: Comparative Study; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

STUDY OBJECTIVES: To evaluate the effect of ramelteon on middle-of-the-night balance, mobility, and memory in older insomniacs. 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. 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. CONCLUSION: In older adults, ramelteon did not impair middle-of-the night balance, mobility, or memory relative to placebo.