for eMaxHealthChronic Insomnia, Generalized Anxiety Disorder
Sanofi-aventis announced results from a new study that showed Ambien CR (zolpidem tartrate extended-release) tablets CIV provided improvement in sleep onset, sleep maintenance and total sleep time for patients with co-morbid chronic insomnia and generalized anxiety disorder (GAD) compared to placebo. Ambien CR also improved sleep-related next-day functioning measures.
About the Study
This study was a multi-center, double-blind, parallel-group, randomized, placebo-controlled trial in 381 adults ages 21 to 64 with co-morbid chronic insomnia and GAD. The study evaluated the overall improvement of insomnia, as measured by total sleep time in patients treated with Ambien CR and the antidepressant escitalopram (Lexapro(R)) compared to treatment with placebo and escitalopram. Patients received Ambien CR 12.5 mg (n=191) or placebo (n=190) each night followed by 10 mg of escitalopram each day during the 8-week study, followed by a one-week period of escitalopram only. Treatment was well tolerated during the study and adverse events were similar between treatment groups.
"The anxiety experienced by patients with GAD can often lead to sleep problems such as difficulty falling asleep or staying asleep," says Thomas Roth, PhD, director of the Sleep Disorders and Research Center at Henry Ford Hospital. "Data from this study show that Ambien CR can be considered a treatment option for the insomnia in GAD to help them get the full night's sleep they need to maintain their next-day functioning."
Researchers assessed treatment efficacy during clinic visits at Weeks 1, 2, 4, 6 and 8 and through daily patient-reported Morning Sleep Questionnaires (MSQ). The MSQ measured the primary efficacy outcome of total sleep time in addition to measurements of sleep onset latency, wake time after sleep onset, number of awakenings, quality of sleep and sleep-related next-day functioning.
Ambien CR Improved Sleep Quality and Sleep Impact on Daily Activities in GAD Patients
Total sleep time was increased in the Ambien CR group throughout the study. At Week 8, patients reporting sleeping an average of 106 minutes more than baseline compared to placebo-treated patients who reported sleeping an average 68 minutes more (P<0.0001). On average, Ambien CR-treated patients reported falling asleep sooner and exhibited improved sleep maintenance based upon fewer nighttime awakenings and decreased wake time after sleep onset compared to placebo-treated patients (P<0.0001). At Week 8, the number of nighttime awakenings decreased in the Ambien CR/escitalopram group (-1.33 + or - 1.26) compared to the placebo/escitalopram group (-0.76 + or - 1.02), and time to sleep onset was reduced 55.1 (+ or - 67.3) minutes with Ambien CR compared to a reduction of 26.8 (+ or - 58.7) minutes with placebo (P<0.0001). In addition, patients reported improvements in secondary measures relating to daytime functioning, including morning energy, morning concentration and sleep impact on daily activities.
Adverse events occurred in 76% of patients treated with Ambien CR/escitalopram and 71% of the patients treated with placebo/escitalopram. The most frequent adverse events experienced by both treatment groups were nausea, dizziness and fatigue. These adverse events have been reported in previous studies of both Ambien CR and escitalopram and are known to be part of the safety profile of both treatments. One patient in each treatment group experienced different serious adverse events.
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