Daridorexant benefits women with insomnia during menopausal transition

Treatment with daridorexant improved sleep outcomes and daytime functioning in women with insomnia disorder during the menopausal transition, according to a study presented at EAN 2025.

“During the menopausal transition, sleep disturbance is one of the most common and burdensome manifestations experienced by women, with more than one-quarter suffering from insomnia disorder,” said the researchers. Despite this, it remains under-researched.

A subgroup of 117 women aged 47–55 years, an age group representative of the menopausal transition, with insomnia disorder were randomly assigned to receive oral daridorexant 25 mg (n=43) or 50 mg (n=35) or placebo (n=39) for 3 months.

Efficacy endpoints

Compared with placebo, women treated with either dose of daridorexant had a greater decrease in WASO* as early as 1 month, which was maintained through 3 months (least squares mean [LSM] change from baseline, -35.7 [25 mg] and -42.9 [50 mg] vs -29.1 min).

The latency to persistent sleep was also reduced by 31 min in the 25-mg daridorexant group and 34.2 min in the 50-mg daridorexant group compared with 19.5 min in the placebo group.

Notably, the 50-mg daridorexant group showed the greatest increase in self-reported total sleep time compared with both the 25-mg daridorexant and placebo groups at 3 months (LSM change from baseline, 75.3 vs 50.9 and 53.5 min, respectively).

Improved IDSIQ** total score was also observed with daridorexant 50 mg compared with placebo (LSM change from baseline, -21.9 vs -17.8). However, this effect was minimal with daridorexant 25-mg dosing (LSM change from baseline, -14.4).

Taken together, “the data suggest that daridorexant 50 mg may provide a [greater] benefit in improving sleep onset and maintenance and daytime functioning in this subgroup of women,” said the researchers.

Safety endpoints

The proportion of patients with treatment-emergent adverse events (AEs) was similar between the daridorexant (n=15 [25 mg] and n=16 [50 mg]) and placebo (n=15) groups. Nasopharyngitis, headache, and somnolence were the most common AEs observed in both groups.

The morning sleepiness VAS*** scores were improved and comparable across all treatment groups from baseline to month 3 (14.8 [25 mg] and 14.1 [50 mg] in the daridorexant group vs 15.7 in the placebo group).

“Daridorexant was well tolerated, with no increased risk of next-morning sleepiness or daytime somnolence,” said the researchers.

“This subgroup post hoc analysis is the first evaluation of the efficacy and safety of daridorexant in women with insomnia disorder during the menopausal transition age,” they noted.