PMID- 37950346
OWN - NLM
STAT- MEDLINE
DCOM- 20240209
LR  - 20240209
IS  - 1550-9109 (Electronic)
IS  - 0161-8105 (Linking)
VI  - 47
IP  - 2
DP  - 2024 Feb 8
TI  - Clinical safety and narcolepsy-like symptoms of dual orexin receptor antagonists 
      in patients with insomnia: a systematic review and meta-analysis.
LID - zsad293 [pii]
LID - 10.1093/sleep/zsad293 [doi]
AB  - STUDY OBJECTIVES: Dual orexin receptor antagonists (DORAs) are emerging 
      treatments for insomnia. This meta-analysis study aimed to assess the safety of 
      FDA-approved DORAs (suvorexant, lemborexant, and daridorexant), focusing on 
      narcolepsy-like symptoms associated with these drugs. METHODS: Five prominent 
      databases were searched to identify randomized controlled trials (RCTs) on this 
      topic. Primary safety outcomes included treatment-emergent adverse events 
      (TEAEs), treatment-related TEAEs, TEAEs leading to discontinuation, and serious 
      TEAEs. Excessive daytime sleepiness (EDS), sleep paralysis, and hallucinations 
      were categorized as adverse events (AEs)-related narcolepsy-like symptoms. 
      RESULTS: Eleven RCTs with 7703 patients were included. DORAs were associated with 
      a higher risk of TEAEs (risk ratio [RR], 1.09; 95% confidence interval [CI], 1.03 
      to 1.15) and treatment-related TEAEs (RR, 1.69; 95% CI: 1.49 to 1.92) when 
      compared to placebo. The DORA group exhibited a significantly higher risk of EDS 
      (RR, 2.15; 95% CI: 1.02 to 4.52) and sleep paralysis (RR, 3.40; 95% CI: 1.18 to 
      9.80) compared to the placebo group. CONCLUSION: This meta-analysis achieved a 
      comparative evaluation of the clinical safety and tolerability of FDA-approved 
      DORAs for primary insomnia, specifically focusing on AEs-related narcolepsy-like 
      symptoms. This study contributes to understanding the safety profile of 
      FDA-approved DORAs for treating insomnia.
CI  - (c) The Author(s) 2023. Published by Oxford University Press on behalf of Sleep 
      Research Society. All rights reserved. For permissions, please e-mail: 
      journals.permissions@oup.com.
FAU - Na, Hyun-Jin
AU  - Na HJ
AD  - College of Pharmacy, Kyungsung University, Busan, Republic of Korea.
FAU - Jeon, Nakyung
AU  - Jeon N
AUID- ORCID: 0000-0001-5500-8841
AD  - College of Pharmacy and Research Institute for Drug Development, Pusan National 
      University, Busan, Republic of Korea.
FAU - Staatz, Christine E
AU  - Staatz CE
AUID- ORCID: 0000-0002-4595-9376
AD  - School of Pharmacy, University of Queensland, Pharmacy Australia Centre of 
      Excellence, Brisbane, QLD, Australia.
FAU - Han, Nayoung
AU  - Han N
AUID- ORCID: 0000-0003-4796-8564
AD  - College of Pharmacy, Jeju National University, Jeju, Republic of Korea.
FAU - Baek, In-Hwan
AU  - Baek IH
AUID- ORCID: 0000-0002-9538-0565
AD  - College of Pharmacy, Kyungsung University, Busan, Republic of Korea.
AD  - School of Pharmacy, University of Queensland, Pharmacy Australia Centre of 
      Excellence, Brisbane, QLD, Australia.
AD  - Functional Food and Drug Convergence Research Center, Industry-Academic 
      Cooperation Foundation, Kyungsung University, Busan, Republic of Korea.
LA  - eng
GR  - National Research Foundation of Korea/
GR  - 2022R1F1A1063144/Korea Government/
PT  - Journal Article
PT  - Meta-Analysis
PT  - Systematic Review
PL  - United States
TA  - Sleep
JT  - Sleep
JID - 7809084
RN  - 0 (Orexin Receptor Antagonists)
SB  - IM
MH  - Humans
MH  - *Sleep Initiation and Maintenance Disorders/drug therapy
MH  - Orexin Receptor Antagonists/adverse effects
MH  - *Sleep Paralysis
MH  - *Narcolepsy/drug therapy
OTO - NOTNLM
OT  - daridorexant
OT  - dual orexin receptor antagonists
OT  - insomnia
OT  - lemborexant
OT  - meta-analysis
OT  - safety
OT  - suvorexant
EDAT- 2023/11/11 11:47
MHDA- 2024/02/09 06:42
CRDT- 2023/11/11 00:10
PHST- 2023/08/17 00:00 [received]
PHST- 2023/11/02 00:00 [revised]
PHST- 2024/02/09 06:42 [medline]
PHST- 2023/11/11 11:47 [pubmed]
PHST- 2023/11/11 00:10 [entrez]
AID - 7394901 [pii]
AID - 10.1093/sleep/zsad293 [doi]
PST - ppublish
SO  - Sleep. 2024 Feb 8;47(2):zsad293. doi: 10.1093/sleep/zsad293.