Sublingual zolpidem in early onset of sleep compared to oral zolpidem:
polysomnographic study in patients with primary insomnia.
Author(s): Staner C, Joly F, Jacquot N, Vlasova ID, Nehlin M, Lundqvist T, Edenius C, Staner
L.
Affiliation(s): Forenap Pharma, Rouffach, France.
Publication date & source: 2010, Curr Med Res Opin. , 26(6):1423-31
OBJECTIVE: To compare the hypnotic effects of a single dose of a sublingual
formulation of zolpidem (Edluar*) 10 mg vs oral formulation (Ambien dagger ) 10
mg by polysomnography (PSG) in DSM-IV primary insomnia patients. Primary
objective was to compare the two formulations on sleep induction, measured by
latency to persistent sleep (LPS), sleep onset latency (SOL) and latency to stage
1 (ST1L). RESEARCH AND METHODS: This was a randomized, double-blind, two-period,
cross-over multi-centre study in which each period comprised two successive PSG
recording nights. Treatment was administered when PSG recordings started.
Subjective sleep and residual effects were assessed the next morning.
RESULTS: Seventy female and male patients aged 19-64 were analysed. Sublingual
zolpidem significantly shortened LPS by 34% or 10.3 minutes as compared to oral
zolpidem (95% CI: -4.3 min to -16.2 min, p = 0.001). SOL and ST1L were also
significantly shortened (p < 0.01). Furthermore the two formulations were
comparable in terms of sleep maintenance properties based on total sleep time
(TST). The improvement in subjective sleep and next-day residual effects did not
differ between the two treatments. Both routes of administration were well
tolerated.
CONCLUSIONS: The results demonstrate that sublingual zolpidem is superior to an
equivalent dose of oral zolpidem in terms of sleep inducing properties in a
carefully selected sample of primary insomnia patients.
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