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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

Zolpidem (Ambien®, Ambien CR®, Edluar®, Intermezzo®, Zolpimist®): Basic Information

Zolpidem (Ambien® and generic, Ambien CR® and generic, Edluar®, Intermezzo® and generic, and Zolpimist) is a gamma-aminobutyric acid (GABA) A agonist that is used as a hypnotic. Here is basic information about this medication.

FDA-approved indications

A. Short-term treatment of insomnia characterized by difficulty in sleep initiation

Oral tablet (Ambien® and generic), sublingual tablet (Edluar®), or oral spray (Zolpimist®) may be indicated

B. Treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep

Low-dose zolpidem sublingual tablet (Intermezzo® and generic) may be indicated

C. Treatment of insomnia characterized by difficulties with sleep initiation and/or sleep maintenance

Extended-release oral tablet (Ambien CR® and generic) may be indicated

Dosage

1. Short-term treatment of insomnia characterized by difficulty in sleep initiation

a. Oral tablet (Ambien®) or sublingual tablet (Edluar®)

Initial: 5 mg (women), 5 or 10 mg (men) once daily at bed time
Maximum: 10 mg once daily at bed time

b. Oral Spray (Zolpimist®)

Initial: 10 mg (2 sprays) once daily at bedtime
Maximum: 10 mg once daily at bedtime

2. Treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep

Low-dose sublingual tablet (Intermezzo®): 1.75 mg (women), 3.5 mg (men)

Note: Indicated only if more than four hours remain before the planned time of waking

3. Treatment of insomnia characterized by difficulties with sleep maintenance and/or sleep initiation

Extended-release tablet (Ambien CR®)

Initial: 6.25 mg (women), 6.25 mg or 12.5 mg (men) once daily at bed time
Maximum: 12.5 mg once daily at bedtime

Special Considerations: In elderly, debilitated, and patients with hepatic impairment start with the lowest dose (refer to prescribing information for details)

Dosage forms and strengths

Oral tablet (Ambien®): 5 mg, 10 mg

Sublingual tablet (Edluar®): 5 mg, 10 mg

Extended-release tablet (Ambien CR®): 6.25 mg, 12.5 mg

Oral Spray (Zolpimist®): Each spray (metered actuation) delivers 5 mg zolpidem in 0. 1 mL

Low-dose sublingual tablet (Intermezzo®): 1.75 mg and 3.5 mg

Please refer to Prescribing Information (see link below) for complete discussion of dosage, administration, warnings and precautions, contraindications, etc.

Related Pages
Practical tips on using hypnotics: the Z drugs
Practical tips on using hypnotics: benzodiazepines
Three important pieces of information about benzodiazepines
Relaxation Practice: A Simple and Powerful Tool for Anxiety, Tension, and Insomnia
Sleep Hygiene worksheets-Part 1 and Part 2
Sleep log: Ten important questions about the person’s sleep
References
Zolpidem oral tablet prescribing information
Zolpidem sublingual tablet prescribing information
Zolpidem extended-release oral tablet prescribing information
Zolpidem oral spray prescribing information
Zolpidem low-dose sublingual tablet prescribing information

Copyright 2016, Rajnish Mago, MD.