SEATTLE, WA—Milnacipran does not directly improve sleep continuity and architecture but its impact on sleep improvement can be attributed to its effectiveness in reducing pain, according to data presented by Rozina Aamir, MS, MBA, of the Cleveland Sleep Research Center in Middleburg Heights, OH at SLEEP 2015.
Milnacipran is a selective serotonin reuptake inhibitor (SSRI) commonly used to address fibromyalgia symptoms, which include widespread focal pain, fatigue, and non-restorative sleep. Reduced or fragmented sleep and pain severity are closely related, so Aamir and colleagues were interested in evaluating the impact of milnacipran on fibromyalgia subject experiencing disturbed sleep.
The randomized, double-blind, placebo-controlled, two-way crossover trial focused on 19 subjects (two males, 17 females), age 28–72 years, with a diagnosis of fibromyalgia and sleep difficulty (based on subjective history and daily diaries). Subjects were randomized to either a milnacipran-placebo, or a placebo-milnacipran sequence. Subjective assessments, including the Brief Pain Inventory (BPI) and overnight polysomnography, were measured at baseline and at the end of each five-week treatment period. Participants recorded their subjective sleep quality in a daily diary using a numerical rating scale from 0 (very poor) to 10 (excellent). A responder analysis was utilized for subjects with a BPI 25% reduction in pain interference with daily activities, compared to baseline.
Overall, subjects did not show improvement in objective sleep parameters, based on polysomnography. However, 10 subjects showed significant reduction in pain on milnacipran, compared to placebo (paired difference 95% CI: -1.44 [-2.83, -0.05]; t(P): -2.350 [0.043]). The reduction in pain parameter was accompanied by a significant improvement in subjective sleep quality (paired difference 95% CI: 0.64 [0.04, 1.24]; t(P): 2.396 [0.040]).
The researchers concluded that their study confirms the effectiveness of milnacipran in reducing pain and thereby exerting effectiveness in improving sleep.