Lemborexant for the Treatment of Insomnia
| Autor: | Feride Frech, Timothy Juday, Norman Atkins, Leslie Citrome |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Pyridines Ramelteon Benzodiazepines Young Adult Zaleplon Sleep Initiation and Maintenance Disorders Internal medicine Acetamides medicine Humans Hypnotics and Sedatives Eszopiclone business.industry Suvorexant Azepines Number needed to harm Middle Aged Triazoles Discontinuation Zolpidem Psychiatry and Mental health Pyrimidines Treatment Outcome Tolerability Number needed to treat Female Orexin Receptor Antagonists Sleep business medicine.drug |
| Zdroj: | The Journal of Clinical Psychiatry. 82 |
| ISSN: | 1555-2101 |
| DOI: | 10.4088/jcp.20m13795 |
| Popis: | Objective: To describe lemborexant for the treatment of insomnia (DSM-5) in adults using number needed to treat (NNT), number needed to harm (NNH), and likelihood to be helped or harmed (LHH). Methods: Lemborexant data were obtained from two Phase 3 trials conducted 2016-2018. Efficacy was assessed using different categorical definitions for response, and tolerability was assessed by evaluating rates of adverse events (AEs). Direct comparisons were made with zolpidem extended release (ER), and indirect comparisons were made with other hypnotic agents, including suvorexant, doxepin, ramelteon, zolpidem immediate release, eszopiclone, zaleplon, and selected benzodiazepines, using data from published reports and regulatory documents. Results: Lemborexant had a clinically relevant magnitude of therapeutic effect, as evidenced by NNT values versus placebo as robust as 3 (95% CI, 2-3). In general, NNH values for lemborexant versus placebo were ≥ 10, suggesting that lemborexant is relatively tolerable. Somnolence was the most common AE, with NNH estimates of 28 (95% CI, 18-61) and 15 (95% CI, 11-22) for lemborexant 5 mg and 10 mg, respectively. Rates of discontinuation of lemborexant because of an AE were low, and for lemborexant 5 mg the rate was lower than that for placebo. LHH contrasting the statistically significant endpoint efficacy measures versus discontinuation because of an AE ranged from 13 to 54. NNT values for lemborexant were generally more robust than for zolpidem ER for the polysomnography and sleep diary outcomes. In indirect comparisons, NNT data for the other hypnotics demonstrated effect sizes that were generally similar to those for lemborexant. Conclusions: In Phase 3 trials, the benefit-risk ratio for lemborexant is favorable as measured by NNT, NNH, and LHH. Trial Registration: ClinicalTrials.gov identifiers: NCT02783729, NCT02952820. |
| Databáze: | OpenAIRE |
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