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Edluar vs ambien: Edluar Reviews & Ratings – Drugs.com

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Sublingual zolpidem in early onset of sleep compared to oral zolpidem: polysomnographic study in patients with primary insomnia

Randomized Controlled Trial

. 2010 Jun;26(6):1423-31.

doi: 10.1185/03007991003788225.

Corinne Staner 
1
, Frédéric Joly, Nathalie Jacquot, Irina D Vlasova, Maria Nehlin, Thomas Lundqvist, Charlotte Edenius, Luc Staner

Affiliations

Affiliation

  • 1 Forenap Pharma, Rouffach, France.

  • PMID:

    20397964

  • DOI:

    10.1185/03007991003788225

Randomized Controlled Trial

Corinne Staner et al.

Curr Med Res Opin.

2010 Jun.

. 2010 Jun;26(6):1423-31.

doi: 10.1185/03007991003788225.

Authors

Corinne Staner 
1
, Frédéric Joly, Nathalie Jacquot, Irina D Vlasova, Maria Nehlin, Thomas Lundqvist, Charlotte Edenius, Luc Staner

Affiliation

  • 1 Forenap Pharma, Rouffach, France.

  • PMID:

    20397964

  • DOI:

    10.1185/03007991003788225

Abstract


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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Publication types

MeSH terms

Substances

Sublingual zolpidem (Edluar™; Sublinox™) – PubMed

Review

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1
, Emma D Deeks

Affiliation

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    23034583

  • DOI:

    10. 1007/s40263-012-0009-y

Abstract

Zolpidem is a non-benzodiazepine hypnotic used in the short-term treatment of insomnia. A sublingual orally disintegrating tablet formulation of zolpidem (Edluar™; Sublinox™) has been developed to provide a more rapid onset of action than oral immediate-release zolpidem. Sublingual zolpidem has demonstrated bioequivalence to oral zolpidem. In a randomized, double-blind, double-dummy, crossover, multi-centre study in adult patients with primary insomnia (n = 70), a single 10-mg dose of sublingual zolpidem significantly reduced latency to persistent sleep (primary endpoint) compared with a single 10-mg dose of oral immediate-release zolpidem. Sleep-onset latency and latency to stage 1 sleep were also significantly shorter with sublingual zolpidem than with oral zolpidem. Moreover, compared with the oral formulation, sublingual zolpidem was noninferior in terms of total sleep time and did not significantly differ in terms of duration of wake after sleep onset. Sublingual zolpidem was generally well tolerated in this trial, with most adverse events being of mild or moderate severity. The overall tolerability profile of sublingual zolpidem was similar to that of oral zolpidem.

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