Long-term effectiveness and safety of lemborexant in adults with insomnia disorder: results from a phase 3 randomized clinical trial

Yardley, Jane; Kärppä, Mikko; Inoue, Yuichi; Pinner, Kate; Perdomo, Carlos; Ishikawa, Kouhei; Filippov, Gleb; Naoki, Katsuhiko; Moline, Margaret

doi:10.1016/j.sleep.2021.01.048

Cited by 49 publications

(69 citation statements)

References 29 publications

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“…There were no reports of rebound insomnia or withdrawal following treatment discontinuation after 12 months. 3 There were no statistically significant differences in adverse events across the placebo and lemborexant groups in the six-month analysis. 2 Adverse events caused discontinuation in 3.8% of the placebo group, 4.1% of the lemborexant 5 mg group, and 8.3% of the lemborexant 10 mg group.…”

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confidence: 84%

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New drug: Lemborexant for insomnia

2021

Aust Prescr

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confidence: 84%

“…There were no reports of rebound insomnia or withdrawal following treatment discontinuation after 12 months. 3 …”

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confidence: 99%

New drug: Lemborexant for insomnia

2021

Aust Prescr

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“…The objective of the second phase 3 trial evaluating lemborexant was to examine the long-term efficacy and safety of lemborexant compared with placebo in adults with insomnia over the course of 6 months (period 1) and 12 months (period 2). 35,38 This was a multicenter, parallel-group, placebo-controlled, randomized controlled trial with 119 sites in North America, Europe, Asia, and Oceania. In contrast to SUNRISE 1, which was limited to older adults, the study population of SUNRISE 2 included adults of all ages (≥18 years).…”

Section: Clinical Trialsmentioning

confidence: 99%

Review of the Efficacy and Safety of Lemborexant, a Dual Receptor Orexin Antagonist (DORA), in the Treatment of Adults With Insomnia Disorder

Waters

2021

Ann Pharmacother

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Objective To provide an overview of the efficacy and safety of lemborexant in the treatment of insomnia disorder by assessing the currently available literature. Data Sources A literature search of PubMed was performed (2010 to March 2021) using the following search terms: lemborexant, sleep, orexin Study Selection and Data Extraction All relevant English-language studies were reviewed and considered, with a focus on phase 3 trials. Data Synthesis The efficacy and safety of lemborexant in the treatment of insomnia disorder in adults was demonstrated in 2 phase 3 trials. Lemborexant significantly reduced latency to persistent sleep compared with placebo. The first study also demonstrated a significant reduction compared with the active control zolpidem ER. Somnolence and headache were relatively common, but the marked adverse effects associated with other medications commonly used to treat insomnia, such as cognitive and psychomotor impairment and complex sleep-related behaviors, were not observed. Relevance to Patient Care and Clinical Practice Although nonpharmacological therapy is considered first-line treatment for insomnia disorder, pharmacological treatment is most commonly utilized. Lemborexant is a viable pharmacological treatment option for patients who are unable to tolerate the adverse effects associated with the most commonly prescribed medications for insomnia, such as benzodiazepines and sedative-hypnotics (Z drugs). This is especially true for geriatric patients, who may be more sensitive to these adverse effects. Conclusion Lemborexant can be recommended to treat insomnia disorder when pharmacological treatment is warranted. It has demonstrated efficacy in clinical trials and is likely better tolerated than most currently available treatment options.

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“…In Study E2006-G000-303 (Study 303; SUNRISE 2; NCT02952820), which enrolled adults with insomnia disorder, LEM treatment was associated with significantly greater benefits on subjective parameters of sleep onset and sleep maintenance compared with PBO early in the study (first 7 nights) and through the end of the PBO-controlled treatment period (month 6) [ 13 ]. Improvements in subjective sleep onset latency (sSOL), subjective sleep efficiency (sSE), subjective wake after sleep onset (sWASO), and subjective total sleep time (sTST) were maintained through 12 months [ 15 ]. In addition, LEM was generally well tolerated across 12 months of treatment [ 15 ].…”

Section: Introductionmentioning

confidence: 99%

“…Improvements in subjective sleep onset latency (sSOL), subjective sleep efficiency (sSE), subjective wake after sleep onset (sWASO), and subjective total sleep time (sTST) were maintained through 12 months [ 15 ]. In addition, LEM was generally well tolerated across 12 months of treatment [ 15 ]. Most treatment-emergent adverse events (TEAEs) were rated as mild or moderate in severity; the most common TEAEs included somnolence, nasopharyngitis, and headache [ 13 , 15 ].…”

Section: Introductionmentioning

confidence: 99%