PMID- 37796657
OWN - NLM
STAT- MEDLINE
DCOM- 20231010
LR  - 20231018
IS  - 1555-2101 (Electronic)
IS  - 0160-6689 (Linking)
VI  - 84
IP  - 6
DP  - 2023 Oct 2
TI  - Lemborexant and Daridorexant for the Treatment of Insomnia: An Indirect 
      Comparison Using Number Needed to Treat, Number Needed to Harm, and Likelihood to 
      Be Helped or Harmed.
LID - 23m14851 [pii]
LID - 10.4088/JCP.23m14851 [doi]
AB  - Objective: To determine if there are differences in the number needed to treat 
      (NNT), number needed to harm (NNH), and likelihood to be helped or harmed (LHH) 
      between lemborexant and daridorexant and to compare lemborexant with daridorexant 
      indirectly. Methods: Dichotomous efficacy and tolerability outcomes reported for 
      Phase 3 daridorexant trials (conducted May 29, 2018-May 14, 2020) for months 1 
      and 3 were identified from published literature and regulatory documents. 
      Analogous data were extracted for lemborexant from Phase 3 studies (conducted May 
      31, 2016-January 8, 2019). NNT, NNH, and LHH were then calculated. Results: 
      Lemborexant 5 mg and 10 mg had clinically relevant therapeutic effect sizes, 
      evidenced by most NNT values versus placebo < 10 for Insomnia Severity Index 
      [ISI], subjective total sleep time [sTST], and polysomnography outcomes. NNH 
      values for adverse events (AEs) were > 10, suggesting relative tolerability. 
      Somnolence was the most common AE. Discontinuation rates of lemborexant because 
      of an AE were low, including for somnolence. Efficacy outcomes for daridorexant 
      25-mg and 50-mg doses pooled resulted in most NNT values versus placebo >/= 10, 
      with more robust NNT estimates for the 50-mg dose than for the 25-mg dose. 
      Discontinuation rate because of an AE at month 3 was higher for placebo than for 
      daridorexant, rendering favorable LHH calculations. Daridorexant evidenced low 
      rates of somnolence or fatigue. Conclusions: In Phase 3 trials, the benefit-risk 
      ratios for both lemborexant and daridorexant were favorable as measured by NNT, 
      NNH, and LHH. Indirect comparisons of lemborexant with daridorexant suggest an 
      efficacy advantage for lemborexant and a tolerability advantage for daridorexant. 
      Clinical Trials Registration: NCT02783729, NCT02952820, NCT03545191, NCT03575104.
CI  - (c) Copyright 2023 Physicians Postgraduate Press, Inc.
FAU - Citrome, Leslie
AU  - Citrome L
AD  - Department of Psychiatry and Behavioral Sciences, New York Medical College, 
      Valhalla, New York.
AD  - Corresponding Author: Leslie Citrome, MD, MPH, 11 Medical Park Drive, Suite 102, 
      Pomona, NY 10970 (nntman@gmail.com).
FAU - Juday, Timothy R
AU  - Juday TR
AD  - Eisai Inc., Nutley, New Jersey.
FAU - Lundwall, Christie
AU  - Lundwall C
AD  - Eisai Inc., Nutley, New Jersey.
LA  - eng
SI  - ClinicalTrials.gov/NCT02952820
SI  - ClinicalTrials.gov/NCT03575104
SI  - ClinicalTrials.gov/NCT02783729
SI  - ClinicalTrials.gov/NCT03545191
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20231002
PL  - United States
TA  - J Clin Psychiatry
JT  - The Journal of clinical psychiatry
JID - 7801243
RN  - 0 (daridorexant)
RN  - 0K5743G68X (lemborexant)
SB  - IM
MH  - Humans
MH  - *Sleep Initiation and Maintenance Disorders/drug therapy
MH  - Sleepiness
MH  - Treatment Outcome
MH  - Clinical Trials, Phase III as Topic
EDAT- 2023/10/05 18:42
MHDA- 2023/10/09 06:42
CRDT- 2023/10/05 12:33
PHST- 2023/10/09 06:42 [medline]
PHST- 2023/10/05 18:42 [pubmed]
PHST- 2023/10/05 12:33 [entrez]
AID - 23m14851 [pii]
AID - 10.4088/JCP.23m14851 [doi]
PST - epublish
SO  - J Clin Psychiatry. 2023 Oct 2;84(6):23m14851. doi: 10.4088/JCP.23m14851.