Evaluating lemborexant for the treatment of insomnia

ABSTRACT

Introduction

Insomnia is a complex sleep disorder that compromises quality of life and affects approximately 10% of the general population. Insomnia, defined as trouble initiating or maintaining sleep associated with impaired daytime function or distress, is treated using a comprehensive approach comprised of cognitive behavioral therapy and pharmacotherapy. Lemborexant, a dual orexin receptor antagonist, is a new pharmacotherapeutic option recently approved for the treatment of insomnia.

Areas covered

Here, the authors describe lemborexant, assess its efficacy and safety profile in clinical trials, and evaluate its role in the current insomnia treatment landscape.

Expert opinion

Lemborexant may offer an improved treatment option compared with other pharmacotherapies for insomnia because it is effective both over the long term and over a wide range of outcome measures. Importantly, lemborexant improves latency to sleep onset and sleep maintenance and is able to help people who experience early morning awakenings. Safety data reveal that lemborexant has minimal residual effects on morning alertness or next day function, and that patients are able to respond to an external auditory stimulus in the middle of the night. In conclusion, lemborexant represents a new, effective, and well-tolerated medication for patients with insomnia.

KEYWORDS:

• Dual orexin receptor antagonist
• insomnia
• lemborexant
• sleep-onset latency
• wakefulness

Article Highlights

• Insomnia is a complex sleep disorder that requires a comprehensive approach to ongoing treatment and management.

• Lemborexant is a new dual orexin receptor antagonist recently approved for treatment of insomnia.

• Lemborexant improves both latency to sleep onset and sleep maintenance, and is effective over the long-term.

• We believe lemborexant will eventually be among the standard care prescriptions written for insomnia.

Acknowledgments

Medical writing assistance was provided by Maureen Wallace, PhD and Janelle Keys, PhD, CMPP of ProScribe – Envision Pharma Group, and was funded by Eisai Inc. ProScribe’s services complied with international guidelines for Good Publication Practice (GPP3). Eisai Inc. was not involved in any aspects of manuscript preparation.

Declaration of interest

G Zammit is an employee and shareholder of Clinilabs Drug Development Corporation. He has an ownership interest in the Sleep Disorders Institute and Home Sleep and Respiratory Care. He has also served as a consultant for Eisai Inc., Janssen Pharmaceuticals, Purdue, and Takeda; and has served on the speaker’s bureau for Merck & Co. Meanwhile, A Krystal has research grants from Axsome Therapeutics, Janssen Pharmaceuticals, Reveal Biosensors, the National Institutes of Health, and the Ray and Dagmar Dolby Family Fund; he has served as a consultant for Adare, Axsome Therapeutics, Big Data, Eisai, Evexia, Ferring Pharmaceuticals, Galderma, Harmony Biosciences, Idorsia, Janssen Pharmaceuticals, Jazz Pharmaceuticals, Merck, Millennium Pharmaceuticals, Neurocrine Biosciences, Otsuka Pharmaceuticals, Pernix, Sage, and Takeda. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

One reviewer is a consultant for Eisai. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Box 1. Drug summary

Additional information

Funding

The authors are supported by Eisai, Inc. who provided funding for the medical writing.