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

Abstract

Objective:

To compare the hypnotic effects of a single dose of a sublingual formulation of zolpidem (Edluar) 10 mg vs oral formulation (Ambien) 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.

Key words::

• Polysomnography
• Primary insomnia
• Sleep initiation
• Sublingual
• Zolpidem

Transparency

Declaration of funding

This study was sponsored by Orexo AB. Preparation and publication of this article was supported by Orexo AB.

Declaration of financial/other relationships

M.N., C.E. and T.L. have disclosed that they were, at time of the study, employees of Orexo AB. C.S., N.J., L.S. and F.J. have disclosed that they were, at time of the study, employees of Forenap Pharma, a contract research organization that received funding from Orexo AB to perform the study. I.D.V. has disclosed receiving financial support from Orexo and Forenap.

Acknowledgement

The authors thank the investigators who played an active role in the achievement of the present study: E. Alekseeva (Russia), O. Chizhova (Russia), I. De Volder (Belgium), J. Haba-Rubio (France), A. Kirpishov (Russia), V. Kulyutkin (Russia), E. Sagutdinova (Russia), M. Smirnov (Russia).

An abstract containing data from this paper was presented at the New Research Approaches for Mental Health Interventions meeting, Phoenix, AZ, USA, 27–30 May 2008.

Notes

*Edluar is a registered trade name of Meda, Solna, Sweden.

†Ambien is a registered trade name of Sanofi-Aventis, Paris, France.