Zolpidem extended-release 12.5 mg, taken three to seven nights per week for up to six months, provided sustained and significant improvements in sleep onset and maintenance, and also improved next-day concentration and morning sleepiness in people with insomnia.
The study is published in the January 1 issue of the journal SLEEP.
The study focused on 1,018 patients between 18 and 64 years of age with chronic primary insomnia, who had difficulty initiating or maintaining sleep or experiencing non-restorative sleep for three months or greater. The subjects took either a single dose of zolpidem extended-release or a placebo from three to seven nights per week.
According to the results, there was a statistically significantly greater benefit in the zolpidem group than in the placebo group on patient global ratings of improvement, with no reduction in clinical efficacy over the course of the study and no evidence of rebound insomnia upon drug discontinuation. At the 12-week end point, 89.7 percent of zolpidem extended-release patients reported that the medication helped them sleep, compared with 51.4 percent of placebo patients.
“Approximately 10 percent of the population suffers from chronic insomnia. These individuals are most commonly treated with medications in clinical practice, though for many years we lacked data on the long-term medication management of insomnia,” said Andrew D. Krystal, MD, of Duke University, lead author of the study.
“However, recent studies document the efficacy and safety of nightly treatment with some insomnia agents for periods of up to one year. As the duration of treatment increases, the costs and risks of adverse effects associated with taking a medication nightly become increasingly important considerations. For the chronic insomnia patients who have waxing and waning symptom severity, it may be possible to decrease the costs and risks by employing non-nightly medication dosing. Consistent with this model, nearly half of insomnia patients take their medications on an ?as needed’ basis. Existing studies document the risk-benefit profile of this practice with the insomnia medication zolpidem 10 mg for periods up to three months.”
SLEEP is the official journal of the Associated Professional Sleep Societies, LLC, a joint venture of the AASM and the Sleep Research Society.
Source: American Academy of Sleep Medicine, USA