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Ramelteon not associated with impairments in middle-of-the-night balance, mobility, memory performance among older adults with primary insomnia, data find

Wednesday, December 12 2007 | Comments
Evidence Grade 0 What's This?
Among older adults with primary insomnia, ramelteon may not be associated with impaired balance, mobility, or memory performance during middle-of-the-night awakenings, whereas zolpidem appears to significantly influence all 3 of these measures, new data suggest.

The double-blind, 3-way crossover study included 33 adults aged >=65 years with primary insomnia. Individuals received (in a randomized order) a single night of treatment with ramelteon 8 mg, zolpidem 10 mg, and placebo with a 4- to 10-day washout period between treatments. The study drug was administered approximately 30 min before bedtime.

Researchers woke participants approximately 2 hrs postdose to assess standing balance (NeuroCom EquiTest Sensory Organization Test [SOT]), turning speed and stability (NeuroCom EquiTest Step Quick Turn Test [SQTT]), memory (immediate and delayed word recall tests), and adverse events.

Although the decrease from baseline in SOT composite score at 2 hrs postdose was significantly greater with zolpidem than with placebo (P<.001), differences between ramelteon and placebo were not significant (P=.837; the primary endpoint). Similar results were observed when the ES5 and ES6 conditions of the SOT series were evaluated separately (ramelteon vs placebo, P=.650 and P=.670, respectively; zolpidem vs placebo, P<.001 for both).

In addition, significant increases from baseline in SQTT turn time and turn sway were observed with zolpidem relative to placebo (P<.001 for both), but differences between ramelteon and placebo were not significant (P=.776 and P=.982, respectively).

Immediate memory recall scores also decreased significantly more with zolpidem than with placebo (P=.002); the corresponding difference between ramelteon and placebo was not significant (P=.683). Neither active treatment significantly affected delayed recall scores.

Adverse events were reported by 21.2% of participants after treatment with ramelteon and placebo and by 39.4% of participants after treatment with zolpidem. The most common adverse events included dizziness, headache, nausea, and somnolence.

"These results may be particularly important for older adults who may have to ambulate during the sleep period to use the restroom, to care for a family member, or who walk about in unfamiliar environments (eg, a hospital or nursing home)," the authors concluded. (Wang-Weigand S, et al. Poster NR604.)

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