June 19, 2007

June 18, 2007 (Minneapolis) — For the many women in their menopausal years who struggle for good sleep amid the onslaught of hot flashes, a drug indicated for seizure control and commonly used for pain may provide needed relief.

In a preliminary study presented here at SLEEP 2007: the 21st Annual Meeting of the Associated Professional Sleep Societies, Michael Yurcheshen, MD, assistant professor of neurology at the University of Rochester Medical Center and Strong Sleep Disorders Center, in New York, reported that women treated with gabapentin (Neurontin, Pfizer) had a significant improvement in the quality of their sleep compared with a placebo group.

He opened his talk saying that he could "see the eyes rolling already." In a follow-up interview with Medscape, he explained that gabapentin was approved for seizure control but has been used 90% of the time off label for other indications. "So when you present yet another off-label use, people often say, oh, here is yet another indication for which it wasn't approved."

But despite the frequent off-label use of this drug and the skepticism that may accompany that, the study presented here indicated that for the 44% to 61% of postmenopausal women who complain of insomnia, gabapentin might be effective with few adverse effects.

For this report, Yurcheshen and his colleagues reevaluated data from a parent study that included 59 postmenopausal women who were randomized to receive gabapentin (300 mg three times daily, titrated upward) or placebo for 12 weeks for the treatment of hot flashes. The current study used a scoring method that was validated in 2006 by Cole and colleagues (Cole JC et al. Sleep. 2006; 29:112-116) and uses 3 factors to assess sleep quality. Called the Pittsburgh Sleep Quality Index (PSQI), it relies on a composite score of sleep quality, sleep efficiency, and daily disturbance. Using the PSQI, researchers assessed sleep at 4 and 12 weeks.

Based on the new scoring method, they found that patients randomized to gabapentin had a significant improvement in sleep quality compared with placebo (35% vs 4%, P = 0.05). There were no differences between the 2 groups in sleep efficiency or in daily disturbance.

According to Dr. Yurcheshen, reasons why gabapentin was responsible for a significant increase in sleep quality could include a reduction in hot flashes, an increase in slow-wave sleep, or a hypnotic effect.

"The most common side effect is probably drowsiness," he said, "which in this population is probably quite useful." All other adverse effects, he said, were nonspecific and self-limited. Another thing that makes gabapentin attractive, he said, is that drug interactions with this treatment are minimal.

All of these factors may be of interest to women who are looking for ways to improve sleep and reduce hot flashes without taking on additional risks, such as those associated with hormone-replacement therapy or the use of benzodiazepines, he added.

However, Dr. Yurcheshen pointed out that to provide an evidence-based approach to using gabapentin in this setting, several questions remain to be answered in future studies, such as whether the effect of gabapentin is limited to improving sleep quality, if sleep-quality effects are related to the potential for augmenting slow-wave sleep, and the degree to which the sleep effects relate to decreased nightly hot flashes.

Daniel Buysse, MD, from the University of Pittsburgh School of Medicine, in Pennsylvania, who chaired the session, emphasized the preliminary nature of the study. "I think it is far too early to place [gabapentin] in a context of how useful it is relative to other agents," he told Medscape. "It is a preliminary look, it is interesting, and it deserves a more thorough look.

"I think the main thing is that we need to understand better what the clinical significance of the observed changes were," he added. "It is true that there was a significant effect; how that translates into a clinically meaningful change is the real question."

SLEEP 2007: 21st Annual Meeting of the Associated Professional Sleep Societies: Abstract 0685. June 9-14, 2007.

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