Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause

•This study analysed effect of fezolinetant on sleep disruption in individuals with vasomotor symptoms.•Fezolinetant had a beneficial effect on four measures of sleep disruption.•Favourable results were obtained by week 4 and maintained through 12 weeks.•Sleep disturbance improved with fezolinetant (in doses of 30 mg or 45 mg) according to the scores on the PROMIS SD SF 8b instrument.•The study demonstrates the utility of fezolinetant as an effective nonhormonal treatment for vasomotor symptoms. To analyse the effect of fezolinetant on patient-reported sleep disturbance and impairment in individuals with vasomotor symptoms (VMS) using pooled data from the SKYLIGHT 1 and 2 studies. The SKYLIGHT studies were phase-3, double-blind investigations. Individuals (≥40–≤65 years) who were assigned female at birth and seeking treatment of/relief from moderate-to-severe VMS were enrolled. Participants were randomised to receive placebo, fezolinetant 30 mg, or fezolinetant 45 mg during a 12-week treatment period. Sleep assessments: Patient-Reported Outcomes Measurement Information System Sleep Disturbance – Short Form 8b (PROMIS SD SF 8b), PROMIS Sleep-Related Impairment – Short Form 8a (PROMIS SRI SF 8a), and Patient Global Impression of Change/Severity in SD (PGI-C SD and PGI-S SD). Assessments were completed at baseline (except PGI-C SD), weeks 4 and 12. Overall, 1022 individuals were randomised and took ≥1 dose of study drug. PROMIS SD SF 8b results showed that improvements in sleep disturbance were observed for fezolinetant 30 and 45 mg versus placebo (week 12, least squares [LS] mean differences: −0.6 [95 % confidence interval [CI]: −1.7, 0.4] for 30 mg and –1.5 [−2.5, −0.5] for 45 mg). Similar improvements in sleep impairment were reported using the PROMIS SRI SF 8a (week 12, LS mean differences: –1.1 [95 % CI: −2.1, −0.1] for 30 mg and −1.3 [−2.3, −0.3] for 45 mg). For PGI-C SD at week 12, 33.6 % (98/292 participants) of the placebo group felt much/moderately better versus 40.1 % (110/274) and 51.0 % (154/302) of the fezolinetant 30 mg and 45 mg groups, respectively. For PGI-S SD at week 12, 44.0 % (129/293) of the placebo group had severe/moderate problems versus 41.1 % (113/275) and 36.6 % (111/303) of the fezolinetant 30 mg and 45 mg groups, respectively. The 12-week timeframe for this analysis was limited by the length of the placebo-controlled period. Fezolinetant had a beneficial effect on four measures of sleep disturbance and impairment following treat