Authors
Luis Miguel Moraes Araujo, Arthur Duarte de Sousa, Camila de Carvalho Vieira, João Pedro Pimentel Abreu, Cristiane Fiquene Conti, Melaine Mont'Alverne Lawall Silva, Marcio Moyses de Oliveira
Published in
Arquivos de neuro-psiquiatria. Volume 84. Issue 7. Pages 1-10. Epub Aug 13, 2026.
Abstract
Insomnia is a prevalent disorder associated with impaired daytime functioning and reduced quality of life. Dual orexin receptor antagonists (DORAs) have shown favorable short-term efficacy and safety profiles. However, evidence regarding their long-term (≥ 6 months) effects remains limited.
To synthesize the available evidence on prolonged DORA use in adults with chronic insomnia.
We conducted a systematic review and meta-analysis of randomized controlled trial. Adults with primary insomnia treated with DORAs (suvorexant, lemborexant, or daridorexant) approved by the United States Food and Drug Administration (FDA) for ≥ 6 months were included. The outcomes included patient-reported sleep parameters, adverse events, and treatment discontinuation.
We included 6 randomized controlled trials comprising 3,546 participants. After 6 and 12 months, DORAs improved subjective sleep parameters of efficacy. Overall, DORAs showed adverse events similar to those of placebo at 6 months, but higher rates at 12 months. The overall rate of discontinuation due to adverse events did not differ significantly, although higher doses of certain DORAs increased the discontinuation rate at 6 months.
In chronic insomnia, DORAs provide sustained improvements in key subjective sleep outcomes, with overall acceptable safety and tolerability profiles. Higher doses may be less well tolerated. Additional long-term randomized trials are needed to better define the efficacy and safety of DORAs in clinical practice.
PMID:
42595319
Bibliographic data and abstract were imported from PubMed on 14 Aug 2026.
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