Doxepin Evaluated for Sleep Disturbances in Patients with Chronic Pain
|The following article features coverage from PAINWeek 2017 in Las Vegas, Nevada. Click here to read more of MPR's conference coverage.|
Doxepin, a histamine H1 receptor antagonist, was not only found to be effective at improving sleep outcomes, but also generally well tolerated in patients with diverse demographic and baseline characteristics, according to results of a meta-analysis presented at PAINWeek 2017.
The analysis included data from 6 previously published, double-blinded, randomized, placebo-controlled studies assessing the safety and efficacy of doxepin in adult and elderly patients with primary sleep maintenance insomnia or transient insomnia. The analysis assessed various efficacy and safety outcomes and compared 4 treatment groups: 3mg doxepin, 6mg doxepin, combined active treatment group (3mg+6mg doxepin), and placebo. Efficacy outcomes were evaluated using both polysomnography (PSG) as well as subjective assessments.
The meta-analysis included a total of 1641 patients. The average age of subjects included in the study was between 49 and 58 years old and the majority of patients were female (62.2%) and white (62.9%).
The study authors reported, “Compared with placebo, data for the 3mg, 6mg, and combined active doxepin treatment groups significantly improved all PSG and subjective evaluated sleep outcomes for all days and nights up to Night 30.” Additionally, both the number of events as well as the type of treatment emergent adverse events did not differ between the treatment groups and placebo.
The study authors added, “Safety outcomes such as drowsiness during the day, ability to function during the day, total nap time, digit symbol substitution test and symbol coping test did not significantly differ between placebo and doxepin treatment groups on the day following nighttime treatment.”
Results of the study also found that safety and efficacy outcomes observed in all doxepin treatment groups were not significantly influenced by age, gender, race, past medical history, number of prior medications, or concomitant medication use.
According to this meta-analysis, doxepin is safe and produces improvements in sleep outcomes, regardless of baseline patient characteristics. “These results support that the doxepin treatment effect is robust and generalizable across patient subpopulations,” the study authors conclude.
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1. Taylor R, Pergolizzi J, Raffa R, Wang D, Gould E. Efficacy and Safety of Doxepin in Patients with Sleep Disturbances: A Post-hoc Analysis. NEMA Research, FL. Pernix Therapeutics, NJ.