Sleep Medicine
Volume 13, Issue 2 , Pages 133-138, February 2012

Efficacy and safety of doxepin 6mg in a four-week outpatient trial of elderly adults with chronic primary insomnia

  • Alan Lankford

      Affiliations

    • Sleep Disorders Center of Georgia, 5505 Peachtree Dunwoody Road, Suite 380, Atlanta, GA 30342, USA
    • Corresponding Author InformationCorresponding author. Tel.: +1 404 257 0080; fax: +1 404 257 0592.
    • ,
  • Roberta Rogowski

      Affiliations

    • Somaxon Pharmaceuticals, 6138 Tamilynn Street, San Diego, CA 92122, USA
    • ,
  • Beal Essink

      Affiliations

    • Oregon Center Clinical Investigation, 702 Church Street Northeast, Salem, OR 97301-2404, USA
    • ,
  • Elizabeth Ludington

      Affiliations

    • Somaxon Pharmaceuticals, 6138 Tamilynn Street, San Diego, CA 92122, USA
    • ,
  • H. Heith Durrence

      Affiliations

    • Somaxon Pharmaceuticals, 6138 Tamilynn Street, San Diego, CA 92122, USA
    • ,
  • Thomas Roth

      Affiliations

    • Henry Ford Sleep Disorders Center, 2799 West Grand Boulevard CFP-3, Detroit, MI 48202, USA

Received 7 April 2011; received in revised form 28 September 2011; accepted 29 September 2011.

Abstract 

Introduction

The efficacy and safety of doxepin (DXP), a histamine H1 receptor antagonist, was evaluated in elderly adults with sleep maintenance insomnia.

Methods

This was a randomized, double-blind, placebo-controlled outpatient trial. Elderly adults meeting DSM-IV-TR criteria for primary insomnia were randomized to four weeks of nightly treatment with either DXP 6mg (N=130) or placebo (PBO; N=124). Efficacy was assessed using patient self-report instruments and clinician ratings. Patient-reported endpoints included subjective total sleep time (sTST), subjective wake after sleep onset (sWASO), latency to sleep onset (LSO), sleep quality, and a Patient Global Impression scale (PGI). The primary endpoint was sTST at week 1.

Results

DXP 6mg produced significantly more sTST and less sWASO at week 1 (both p-values <0.0001) than PBO. These significant improvements versus placebo were maintained at weeks 2–4 (all p-values <0.05). There were no significant differences in LSO for DXP 6mg versus PBO. DXP 6mg significantly improved sleep quality (weeks 1, 3, and 4, p<0.05) and several outcome-related parameters, including several items on the PGI, the severity and improvement items of the Clinician Global Impression scale (CGI; weeks 1 and 2) and the Insomnia Severity Index (ISI; weeks 1–4), all versus PBO. There were no reports of anticholinergic effects (e.g., dry mouth) or memory impairment. The safety profile of DXP 6mg was comparable to that of PBO.

Conclusions

In elderly adults with insomnia, DXP 6mg produced significant improvements in sleep maintenance, sleep duration, and sleep quality endpoints that were sustained throughout the trial. These data suggest that DXP 6mg is effective for treating sleep maintenance insomnia and is well-tolerated in elderly adults with chronic primary insomnia.

Keywords: Chronic insomnia, Elderly adults, Sleep maintenance insomnia, Wake time after sleep onset, Low-dose doxepin, Histamine H1 receptor antagonist

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PII: S1389-9457(11)00341-8

doi:10.1016/j.sleep.2011.09.006

Sleep Medicine
Volume 13, Issue 2 , Pages 133-138, February 2012

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