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Sublingual transmucosal zolpidem effective, well-tolerated among individuals with MOTN insomnia, findings show

Wednesday, December 12 2007 | Comments
Evidence Grade 0 What's This?
A low-dose buffered formulation of sublingual transmucosal (ST) zolpidem appears to improve sleep onset and duration among patients with insomnia characterized by middle-of-the-night (MOTN) awakenings, new findings indicate.

The double-blind, 3-way crossover study included 83 adults with primary insomnia and a history of MOTN awakenings.

Participants were randomized to receive placebo, ST zolpidem 1.75 mg, or ST zolpidem 3.5 mg each for 2 nights with a 5- to 12-day washout period between treatments. During each treatment night, the study drug or placebo was administered after a planned awakening 4 hrs after lights out. After dosing, participants were kept awake for 30 min and then allowed to return to bed for an additional 4 hrs.

According to polysomnography data, mean latency to persistent sleep after the planned awakening was 16.9 min with ST zolpidem 1.75 mg and 9.7 min with ST zolpidem 3.5 mg compared with 28.1 min with placebo (P<.001 for both vs placebo). Mean total sleep time (TST) values were 197.8 min, 208.99 min, and 183.12 min, respectively (P<.001 for both vs placebo). Both doses were also associated with significant improvements in sleep efficiency as compared with placebo (P<.001 for both).

In subjective next-day reports, as compared with placebo, both doses were associated with a shorter mean sleep-onset latency (P<.001 for both) and a longer mean TST (P=.011 for ST zolpidem 1.75 mg; P<.001 for ST zolpidem 3.5 mg). The 3.5 mg dose was also associated with a significantly better mean rating of sleep quality relative to placebo (P<.001).

The authors of the study also noted that participants with severe MOTN insomnia (MOTN awake time >=60 min) demonstrated proportionally greater improvements in sleep onset and duration relative to improvements seen in the study population as a whole.

Neither dose of ST zolpidem was associated with residual sedation or impairments in next-day alertness, as assessed with the Digit Symbol Substitution Test and a visual analog scale of sedation.

Adverse events were reported by 8.6% of participants after treatment with placebo, 3.7% of participants after treatment with ST zolpidem 1.75 mg, and 5.0% of participants after treatment with ST zolpidem 3.5 mg. (Hull S, et al. Poster #0707.)

This information concerns a use that has not been approved by the Food and Drug Administration.

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