PARIS – Pooled data from two clinical trials of eszopiclone suggest that elderly insomniacs have more difficulty staying asleep than falling asleep, Judy Caron, Ph.D., reported at the annual congress of the European College of Neuropsychopharmacology.
Before treatment, time to sleep onset was similar across patients aged 18–85, according to Dr. Caron, vice president of product development at Sepracor Inc. in Marlborough, Mass. People 60 years of age and older were awake roughly a third more of the time, however, compared with younger patients. Dr. Caron documented this difference using data on wake time after sleep onset.
In both age groups, measures of sleep onset and sleep maintenance improved significantly with eszopiclone (Lunesta), a sedative hypnotic approved by the U.S. Food and Drug Administration in April 2005 for long-term treatment of insomnia.
“Sleep maintenance really is the major sleep disruption that occurs in the elderly,” Dr. Caron said.
Her presentation drew upon a database of 1,616 insomniacs who participated in two 6-month-long, placebo-controlled trials of eszopiclone. The trials enrolled 1,441 patients aged 18–59 and 175 older patients. Most in both age groups were on the active drug.
Pooled analyses of these studies found daytime alertness, ability to function, and sense of physical well-being to be comparable in both age groups, with similar improvements when treated with eszopiclone. She did not present the data, but Dr. Caron said elderly patients were found to nap less when their insomnia was treated.
She reported adverse events were slightly higher in the elderly on eszopiclone, however, occurring in 90% of older patients vs. 77% of those under the age of 60. Dr. Caron attributed the higher adverse event rate in the elderly primarily to central nervous system events. These occurred in 37% of older patients, compared with 27% of those under the age of 60.
“What is remarkable is there is no difference in terms of accidental injury in the older age group,” she added. About 7% of the elderly and 6% of the younger patients had accidental injuries during the trials.
Insomnia increases with age, Dr. Caron said. The prevalence of insomnia rises from 10% of young adults to 20%–30% in middle age to 33%–55% in those above the age of 65. It is comorbid in 85%–90% of cases, she said.
Worldwide, she estimated that 40% of people suffer from insomnia. Yet, she said, only one in eight patients seek treatment, and physicians rarely ask whether patients are getting enough sleep.
Older patients, who have a significant problem in terms of sleep, especially are undertreated, Dr. Caron said.
Worldwide, 40% of people suffer from insomnia, but only one in eight patients seek treatment. DR. CARON