PMID- 17653697
OWN - NLM
STAT- MEDLINE
DCOM- 20080317
LR  - 20181201
IS  - 0033-3158 (Print)
IS  - 0033-3158 (Linking)
VI  - 195
IP  - 1
DP  - 2007 Nov
TI  - Short-term treatment with gaboxadol improves sleep maintenance and enhances slow 
      wave sleep in adult patients with primary insomnia.
PG  - 139-46
AB  - RATIONALE: Gaboxadol is a selective extrasynaptic GABA(A) agonist, previously in 
      development for the treatment of insomniac patients. OBJECTIVE: To evaluate the 
      acute efficacy and safety of gaboxadol in primary insomnia (PI). METHODS: This 
      was a randomised, double-blind, four-way crossover, polysomnograph study 
      comparing gaboxadol 10 and 20 mg (GBX20) to placebo in 40 adults with the 
      Diagnostic and Statistical Manual of Mental Disorders, 4th edition, criteria for 
      PI. Zolpidem 10 mg was used as an active reference. Treatment was administered on 
      two consecutive nights in each treatment session. Next-day residual effects were 
      evaluated 2 and 9 h after lights on. RESULTS: Efficacy analysis included the 
      per-protocol population (n = 38) from night 2. GBX20 reduced wake after sleep 
      onset (p < 0.01). Both doses of gaboxadol, but not zolpidem, reduced the number 
      of night awakenings (p < 0.001). GBX20 and zolpidem increased total sleep time (p 
      < 0.05). Neither dose of gaboxadol nor zolpidem significantly reduced sleep onset 
      latency, although a trend was seen for zolpidem. Gaboxadol enhanced slow wave 
      sleep (SWS) dose-dependently (gaboxadol 10 mg: p < 0.01, GBX20: p < 0.001). 
      Patients reported improved sleep quality following GBX20 (p < 0.05). Both doses 
      of gaboxadol were generally well tolerated with almost exclusively mild to 
      moderately severe adverse events (AEs). More frequent and severe AEs followed 
      GBX20. No serious AEs were reported. No drug treatment was associated with 
      next-day residual effects. CONCLUSION: Acute administration of gaboxadol improves 
      sleep maintenance and enhances SWS in a dose-dependent manner in adult patients 
      with PI. Gaboxadol was not associated with next-day residual effects. Gaboxadol 
      was generally well tolerated, although gaboxadol showed a dose-dependent increase 
      in incidence and severity of AEs.
FAU - Lundahl, J
AU  - Lundahl J
AD  - Department of Neurology, H Lundbeck A/S, International Clinical Research, 
      Ottiliavej 7-9, 2500, Valby, Denmark. jol@lundbeck.com
FAU - Staner, L
AU  - Staner L
FAU - Staner, C
AU  - Staner C
FAU - Loft, H
AU  - Loft H
FAU - Deacon, S
AU  - Deacon S
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20070727
PL  - Germany
TA  - Psychopharmacology (Berl)
JT  - Psychopharmacology
JID - 7608025
RN  - 0 (GABA Agonists)
RN  - 0 (Isoxazoles)
RN  - 0 (Pyridines)
RN  - 7K383OQI23 (Zolpidem)
RN  - K1M5RVL18S (gaboxadol)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Cross-Over Studies
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Electroencephalography/methods
MH  - GABA Agonists/adverse effects/therapeutic use
MH  - Headache/chemically induced
MH  - Humans
MH  - Isoxazoles/adverse effects/*therapeutic use
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - Polysomnography/methods
MH  - Pyridines/adverse effects/therapeutic use
MH  - Sex Factors
MH  - Sleep Initiation and Maintenance Disorders/*drug therapy/physiopathology
MH  - Sleep Stages/*drug effects/physiology
MH  - Tachycardia/chemically induced
MH  - Time Factors
MH  - Treatment Outcome
MH  - Zolpidem
EDAT- 2007/07/27 09:00
MHDA- 2008/03/18 09:00
CRDT- 2007/07/27 09:00
PHST- 2007/04/17 00:00 [received]
PHST- 2007/06/19 00:00 [accepted]
PHST- 2007/07/27 09:00 [pubmed]
PHST- 2008/03/18 09:00 [medline]
PHST- 2007/07/27 09:00 [entrez]
AID - 10.1007/s00213-007-0866-0 [doi]
PST - ppublish
SO  - Psychopharmacology (Berl). 2007 Nov;195(1):139-46. doi: 
      10.1007/s00213-007-0866-0. Epub 2007 Jul 27.