Gabapentin, a drug initially used to treat seizures, improves sleep quality in menopausal women with hot flashes, University of Rochester Medical Center researchers report online and in the September issue of the Journal of Women's Health.
Approximately 40 percent of menopausal women experience sleep disruption, often in the form of difficulty with sleep initiation and frequent nighttime awakenings. The study is the first to show sustained benefits in sleep quality from gabapentin, which Rochester researchers already have demonstrated alleviates hot flashes.
"Gabapentin improves sleep quality but does not have the potential dependency problems of some other sleep medications and does not involve the use of hormone replacement therapy," said Michael E. Yurcheshen, M.D., assistant professor of Neurology and the lead author of the article.
"It has minimal side effects and it is a generic drug," said Yurcheshen, who is based at the Strong Sleep Disorders Center. "That makes it a very attractive treatment for these problems in this patient population."
For the current study, researchers used data from a previously published randomized, double-blind, placebo-controlled trial of gabapentin in 59 postmenopausal women who experienced seven to 20 hot flashes daily. The subjects took either 300 milligrams of gabapentin three times a day or a placebo.
The research used a factor analysis of the Pittsburgh Sleep Quality Index, a well-known and validated questionnaire, to evaluate sleep. The results showed overall improvement in the sleep quality score, even after 12 weeks of treatment.
Gabapentin's impact on the sleep quality factor in menopausal women may reflect improvement in hot flashes, stabilization of sleep architecture, or a decrease in the amount of time to transition from wakefulness to sleep, the researchers wrote. It is also possible that gabapentin improved sleep quality by addressing underlying sleep pathology, such as restless legs syndrome.
"We really are not sure which mechanism is responsible, but this study suggests that it does work to improve sleep quality," Yurcheshen said.
The gabapentin research reported in the Journal of Women's Health is the most recent in a series of Rochester studies into relief of hot flashes. In 2000, a Medical Center neurologist treating a menopausal woman for migraines first observed that the seizure medication seemed to cure her hot flashes. Since then, a clinical trial confirmed those results in women suffering from hot flashes due to menopause. Another Rochester study showed that gabapentin provides control of hot flashes in women with breast cancer who suffer hot flashes as a result of their cancer treatment. A third study found that gabapentin is as effective in reducing the number of hot flashes as the hormone estrogen, which used to be the gold standard treatment for menopause symptoms.
A co-author on the paper, Thomas Guttuso Jr., M.D., is listed as the inventor on a patent owned by the University of Rochester for the use of gabapentin in the treatment of hot flashes. The patent has been licensed to three companies. Guttuso is a former Medical Center neurologist who is now on the faculty at the State University of New York at Buffalo.
In addition to Yurcheshen and Guttuso, the authors of the article include Michael P. McDermott, Ph.D., associate professor of Biostatistics at the Medical Center, Robert G. Holloway, M.D., M.P.H., professor of Neurology at the Medical Center, and Michael Perlis, Ph.D., associate professor of Psychology at the University of Pennsylvania.