Novel therapeutic usage of low-dose doxepin hydrochloride

Abstract

Low-dose doxepin hydrochloride (1, 3 and 6 mg) is a tricyclic antidepressant currently being investigated for the treatment of primary insomnia in adult and geriatric patients. Although it has been used at much higher doses to treat depression effectively for a number of decades, it offers a unique potency and selectivity for antagonizing the H1 (histamine) receptor at low doses. This mechanism of action may prove to be advantageous compared with other medications currently approved for the treatment of insomnia. This article reviews previous clinical studies using doxepin for insomnia and the recent clinical trial data, and briefly discusses other potential roles of this compound in clinical practice.

Keywords::

• doxepin
• elderly
• geriatric
• histamine antagonist
• primary insomnia
• tricyclic antidepressant

Disclosure

PM Becker has received research grants from sanofi-aventis, GlaxoSmithKline, Sepracor and Takeda. PM Becker is on the Advisory Panel for GlaxoSmithKline and BoehringerIngelheim, and on the Speaker's Bureau for GlaxoSmithKline, sanofi-aventis, Takeda, Sepracor and Boehringer-Ingelheim.

Acknowledgements

HH Durrence (Somaxon Pharmaceuticals, Inc.) provided Phase I summary data and Phase II trials data/manuscripts.

Notes