Nabiximols improves sleep architecture in multiple sclerosis: A prospective polysomnographic study

We aim to evaluate sleep disruption in people with multiple sclerosis (MS) compared to an age- and gender-matched control cohort using patient-reported outcome measures and formal polysomnography (PSG) scoring, and testing the effect of Nabiximols on these measures in people with MS. We enrolled adult individuals with MS who were eligible to receive nabiximols. Clinical variables and self-reported items like Pittsburgh Sleep Quality Index (PSQI) score were collected. Individuals underwent two full-night PSG recordings: baseline and after a 6-week nabiximols trial. Additionally, 24 healthy individuals (18 females; mean age:55.7 ± 9.5 years) were recruited as control cohort. Linear mixed-effects models (LMMs) using clinical and PSG parameters were used. Our cohort of 19 people with MS (16 females; mean age of 50.8 ± 10.2 years) with elevated PSQI (11.7 ± 2.8) exhibited: reduced sleep efficiency (SE)[P < 0.001,q-value = 0.003], reduced total sleep time (TST)[P = 0.0021,q-value = 0.005], higher number of awakenings [P < 0.001,q-value = 0.003], increased arousal-index (AI) [P < 0.001,q-value = 0.003], a greater periodic limb movement index (PLMI) [P < 0.001,q-value = 0.003] and a reduced proportion of REM [P < 0.001,q-value = 0.003] compared with the controls. The 6-weeks nabiximols trial resulted in a significant improvement in the PSQI [β 95%CI = -1.28 (-1.67, -0.88)] and in the following PSG measures: SE [β 95%CI = 1.57 (1.18, 1.95)], TST [β 95%CI = 0.93 (0.46, 1.40)], AI [β 95%CI = -1.41 (-1.79, -1.30)], PLMI [β 95%CI = -1.73 (-2.03, -1.43)] and REM sleep [β 95%CI = 1.44 (1.00, 1.87)]. Our prospective study reported a significant sleep disruption in MS and a great improvement in sleep parameters following a 6-week trial of Nabiximols, as indicated by LMMs using PSQI score and PSG measures. We suggest broadening the therapeutic indications of nabiximols to also include individuals with MS who experience significant sleep disruption.