番茄社区

NEW ORLEANS -- Abnormal dreams and nightmares were not common for insomnia patients treated with lemborexant (Dayvigo), according to two phase III clinical trials.

Overall, few participants in the SUNRISE-1 (1.2%) and SUNRISE-2 (3%) studies reported nightmares or abnormal dreams, reported Margaret Moline, PhD, of Eisai in White Plains, New York, during a poster presentation at Psych Congress.

Across both studies, the overall incidence of nightmares or abnormal dreams was highest with lemborexant 10 mg.

In the SUNRISE-1 study, 1.9% of participants on the 10-mg dose reported abnormal dreams or nightmares compared with 1.1% of those taking zolpidem tartrate extended release, 0.8% of those taking lemborexant 5 mg, and 1% of those in the placebo group.

In the SUNRISE-2 study, both doses of lemborexant led to higher incidence of abnormal dreams or nightmares versus placebo: 3.5% for 10 mg and 3.2% for 5 mg versus 2.2% for placebo.

The majority of patients (80%) reporting nightmares or abnormal dreams were women, which was consistent with the large proportion of women included in the studies, but overall proportions of incidences were similar between women (2.1%) and men (1.8%).

These results suggest that lemborexant is not significantly increasing these adverse events, Moline said.

"What it suggests is that even though REM [rapid eye movement] sleep is increasing with treatment, that it's not associated with a marked increase in the nightmares or dreams," Moline told 番茄社区.

Patients with untreated insomnia have reported abnormal dreams and nightmares, as have those treated with insomnia medications, the study authors said. Lemborexant is a dual orexin receptor antagonist, which increases REM sleep, during which recall of dream content is more likely.

In a study presented last year at the Psych Congress, Moline said that lemborexant helped patients fall asleep faster and increased total sleep time, even in those with a history of depression.

SUNRISE-1 was a 1-month, randomized, double-blind study that used both a placebo control and an active control phase against 5-mg and 10-mg lemborexant. It included 1,006 participants, most of whom were white women with a mean age of 64. SUNRISE-2 was a year-long, randomized, double-blind, placebo-controlled study that included 947 participants, again mostly white women, with a mean age of 54-55.

Moline noted that the majority of study participants being women is consistent with clinical data that show women are more likely to have diagnoses of insomnia that merit treatment.

Participants with comorbid sleep disorders were excluded from both studies, but Moline pointed out that participants with medical or psychiatric conditions were included as long as their condition was stable and would not interfere with the individual's health or the study analysis.

Across both studies, 11 of 28 patients treated with lemborexant who reported nightmares or abnormal dreams said they started within 3 days of treatment initiation.

In SUNRISE-1, treatment-related adverse events occurred in more patients taking lemborexant (11.3% for 5 mg and 14.6% for 10 mg) compared with placebo (7.7%), but fewer than those taking zolpidem tartrate (15.6%). In SUNRISE-2, treatment-related adverse events occurred in more patients overall -- 29% of those taking lemborexant 10 mg, 24.8% of those taking lemborexant 5 mg, and 13.8% of those in the placebo group.

Comment