Insomnia

Regulatory review documents in this library for insomnia include DAYVIGO, Quviviq, and Slenyto. DAYVIGO is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults. For DAYVIGO, the LSGM ratio of sSOL (Month 6 / Baseline) for lemborexant 10 mg vs placebo was 0.70 (Eisai Co., Ltd. — Dayvigo FDA Review, p.149). Quviviq is indicated for the treatment of adult patients with insomnia characterized by symptoms present for at least 3 months and considerable impact on daytime functioning. For Quviviq, the WASO change from baseline (LS mean difference vs placebo) was -22.78 (Idorsia Ltd — Quviviq FDA Review, p.62).

Slenyto is indicated for the treatment of insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and/or Smith-Magenis syndrome where sleep hygiene measures have been insufficient, and for insomnia in children and adolescents aged 6-17 with Attention-Deficit Hyperactivity Disorder (ADHD). For Slenyto, the average sleep onset latency reduction in the Slenyto-treated group was 39.6 (RAD Neurim Pharmaceuticals — Slenyto EMA EPAR variation asse, p.32). It is important to note that different drugs were studied in different trials, and therefore, the reported figures are not directly comparable in a head-to-head manner.