SLEEP 2011 Abstract Supplement

B. Clinical Sleep Science III. Sleep Disorders – Insomnia
based CBT-I could greatly expand access to non-pharmacological treatment
for chronic insomnia.
Support (If Any): This researsh is supported by the MICHR/CTSA Pilot
Grant Program (NIH UL1RR 024986)
0531
IMPROVEMENT IN SLEEP MAINTENANCE AND EARLY
MORNING AWAKENINGS IN ADULT AND ELDERLY
PATIENTS WITH INSOMNIA TREATED WITH DOXEPIN 3
AND 6 MG
Krystal AD 1 , Lankford A 2 , Dorsey B 3 , Rogowski R 3 , Ludington E 3 ,
Durrence H 3 , Roth T 4
1
Psychiatry and Behavioral Sciences, Duke University Medical Center,
Durham, NC, USA, 2 Sleep Disorders Center of Georgia, Atlanta, GA,
USA, 3 Somaxon Pharmaceuticals, Inc., San Diego, CA, USA, 4 Henry
Ford Sleep Disorders Center, Detroit, MI, USA
Introduction: This report reviews the effects of doxepin (DXP) 3 and
6mg on sleep maintenance (SM) and early morning awakenings (EMA).
Methods: SM and EMA endpoints from four double-blind placebocontrolled
trials are reported. Study A was a 12-week trial of elderly
insomnia patients [N=240; DXP 3mg]. Study B was a 5-week trial of
adult insomnia patients (N=221; DXP 3mg and 6mg). Study C was a
4-week trial of elderly insomnia patients (n=255; DXP 6mg). Study D
was a transient insomnia trial (N=565; DXP 6mg). The primary method
of evaluating efficacy was polysomnography (PSG) in Studies A, B,
and D, and patient-reports in Study C. SM endpoints included polysomnographic
wake after sleep onset (WASO) and subjective WASO
(sWASO). EMA was assessed with PSG Sleep Efficiency% in the last
quarter-of-the-night (SE-LQ). Data from the first and final assessment
point [Study A=Night (N) 85; Study B=N29; Study C=WK4] of the
study are reported.
Results: DXP 3 and 6mg significantly improved WASO on N1 in all
PSG trials (p