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


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.
Staner
Corinne
C
Forenap Pharma, Rouffach, France.
Joly
Frédéric
F
Jacquot
Nathalie
N
Vlasova
Irina D
ID
Nehlin
Maria
M
Lundqvist
Thomas
T
Edenius
Charlotte
C
Staner
Luc
L
D000284:Administration, Oral; D000286:Administration, Sublingual; D000328:Adult; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage* / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D017286:Polysomnography; D011725:Pyridines / Q000008:administration & dosage* / Q000494:pharmacology; D012890:Sleep / Q000187:drug effects*; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult; D000077334:Zolpidem
D006993:Hypnotics and Sedatives; D011725:Pyridines; D000077334:Zolpidem