Efficacy and safety of doxepin 6 mg in a model of transient insomnia

Therapeutic rationale for low dose doxepin in insomnia patients

“…In elderly patients, the 4-week study of 6 mg doxepin significantly improved total sleep time and sleep quality versus placebo and these improvements were sustained throughout the trial [25] . Clinical trial in transient insomnia patients (n=565) also demonstrated the effectiveness of doxepin 6 mg in sleep onset, sleep maintenance, sleep duration and sleep quality [28] . Thus doxepin is useful for both sleep maintenance and sleep onset or difficulty in falling sleep.…”

“…Doxepin should be avoided in patients who take anti-depresants, alcohol and sedating antihistaminic. Doxepin is metabolized by CYP isoenzymes, co-administration of cimetidine and sertraline like CYP inhibitors may increase the plasma concentration of doxepin [19,[25][26][27][28][29][30] .…”

“…Third, there is no report of weight gaining or appetite increasing. The most common adverse reactions reported were sedation, somnolence, nausea and upper respiratory tract infection [19,[25][26][27][28][29][30] . During the clinical trial, there is no report for rebound insomnia/withdrawal syndrome after doxepin discontinuation.…”

“…During the clinical trial, there is no report for rebound insomnia/withdrawal syndrome after doxepin discontinuation. Thus doxepin does not produce physical dependence [19,[25][26][27][28][29][30] . Cardiac safety study showed no prolongation of QT interval with 50 mg dose of doxepin [31] .…”

“…Use of low dose doxepin is not associated with tolerance, and anti-cholinergic side effect. Further, it is not associated with weight gain and cardiac re-polarization [19,[25][26][27][28][29][30] .…”