MINNEAPOLIS — A single 6-mg dose of doxepin significantly cut the time needed for adults with transient insomnia to fall soundly asleep, based on data presented at the annual meeting of the Associated Professional Sleep Societies.
The single dose of doxepin also significantly improved the overall duration and quality of the participants' sleep. “These data suggest that doxepin 6 mg may improve all aspects of sleep impairment in adults with transient insomnia,” reported Dr. Howard Schwartz medical director of Miami Research Associates, a research facility and sleep lab.
The 283 subjects who received one 6-mg dose of doxepin reached persistent sleep an average of 13 minutes earlier than the 282 subjects who received a placebo. The reduced time to sleep was the primary end point of the study, which was sponsored by Somaxon Pharmaceuticals, a manufacturer of doxepin.
The 565 participants were otherwise healthy adults who underwent a prestudy phase advance (a technique conducted in a sleep lab to induce transient insomnia). The subjects then received either the drug or a placebo, and their sleep was evaluated using single-night polysomnography data and a patient questionnaire that they completed the next morning.
The polysomnography data also showed that, compared with the placebo group, the doxepin group had a significantly longer total sleep time (51 minutes), woke up significantly later (39 minutes), and reported significantly improved sleep efficiency, compared with the placebo group. In addition, sleep efficiency improved by an average of 10% in the doxepin group, compared with the placebo group, during each of 8 hours and during each third of the night's measurements.