Table 8

Placebo-controlled trials of zolpidem extended-release

Author,
year
(Quality)
PopulationDose, durationMain efficacy results
Roth 2006;107 FDA Study EFC4529 (FAIR)Adults N=21212.5 mg 3 weeksPrimary outcome: Polysomnography-recorded WASO during first 8 hours of the night, mean difference from placebo (95% CI):
Nights 1 and 2: −25 minutes (−34 to −16); P<0.0001
Nights 15 and 16: −7 minutes (−18 to −3); P=0.1913
Secondary outcomes: Polysomnography-recorded sleep latency (mean change from baseline, zolpidem-XR compared with placebo):
Nights 1 and 2: −23 compared with −13 minutes; P<0.0001
Nights 15 and 16: −21 compared with −13 minutes; P=0.0338
Polysomnography-recorded number of awakenings:
Nights 1 and 2: −2.7 compared with −0.8; P<0.0001
Nights 15 and 16: −3.0 compared with −0.9; P<0.0001
Walsh 2008121 (FDA Study 4530) (FAIR)Elderly
N=205
6.25 mg
3 weeks
Primary outcome: Polysomnography-recorded WASO during first 6 hours of the night, adjusted mean difference from placebo (95% CI):
Nights 1 and 2: −25 minutes (−32 to −19); P<0.0001
Nights 15 and 16: −11 minutes (−19 to −3); P=0.0042
Krystal 200889 (FAIR)Adults N=101812.5 mg, as needed, 3 to 7 nights per week 6 monthsPrimary outcome: Patient’s Global Impression at week 12: 89.8% zolpidem-XR compared with 51.4% placebo group said treatment helped them sleep (P<0.0001).
Secondary outcomes: Improvements in patient- reported sleep duration, WASO, sleep latency, quality of sleep, and number of awakenings in treatment group (data reported graphically)

From: Results

Cover of Drug Class Review: Newer Drugs for Insomnia
Drug Class Review: Newer Drugs for Insomnia: Final Report Update 2 [Internet].
Carson S, McDonagh MS, Thakurta S, et al.
Portland (OR): Oregon Health & Science University; 2008 Oct.
Copyright © 2008, Oregon Health & Science University, Portland, Oregon.

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