No strange dreams for insomnia patients taking Lemborexant

New Orleans — Abnormal dreams and nightmares were not uncommon in insomnia patients treated with limburxant (Dayvigo), according to a phase III clinical trial.

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

In both studies, the incidence of nightmares or abnormal dreams was higher with lemborexant 10 mg.

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

In the SUNRISE-2 study, both doses of lemborexant caused 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%) who reported abnormal nightmares or dreams were women, which is consistent with the large proportion of women included in the studies, but the overall incidence rates were similar for women (2.1%) and men (1.8%).

These results indicate that lemborexant does not significantly increase these adverse events, Mullen said.

“What it suggests is that despite REM [rapid eye movement] “Sleep increases with treatment, and is not associated with a significant increase in nightmares or dreams,” Mullen said. MedPage today.

The study authors said that patients with untreated insomnia reported abnormal dreams and nightmares, as did those treated with insomnia medications. Lemborexant is a dual orexin receptor antagonist, which increases REM sleep, during which the content of dreams is more likely to be remembered.

in a study Made last year At the psychiatric conference, Mullen said lemborexant helped patients fall asleep faster and increased total sleep time, even in those with a history of depression.

SUNRISE-1 was a one-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, mostly white women with an average age of 64. SUNRISE-2 was a one-year, randomized, double-blind study involving 947 participants, also mostly white women, with an average age of 54-55.

Mullen noted that the majority of the study participants were women, consistent with clinical data showing that women are more likely to be diagnosed with insomnia that merits treatment.

Participants with comorbid sleep disorders were excluded from both studies, but Mullen noted that participants with medical or psychiatric conditions were included as long as their condition was stable and would not interfere with an individual’s health or study analysis.

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

In SUNRISE-1, treatment-related adverse events occurred in more patients who took lemborexant (11.3% for 5 mg and 14.6% for 10 mg) compared with placebo (7.7%), but less than in those who took zolpidem tartrate (15.6%). ). In SUNRISE-2, treatment-related adverse events occurred in a larger number of 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.

  • Michael Deboe Wilson MedPage Today reporter and investigative team. It covers psychiatry, virology, and infectious diseases, among other relevant US clinical news. Follow

Disclosures

This study was supported by Eisai.

Mullen and other co-authors are employees of Eisai.

One co-author reported counseling for Eisai, Idorsia, Jazz Pharmaceuticals, Merck, Orexo, SEQ, and Takeda.