FDA Approves Lemborexant For Treatment of Insomnia in Adults

  • Insomnia
  • Lemborexant

The Food and Drug Administration (FDA) approved lemborexant (Dayvigo, Eisai, Woodcliff Lake, NJ) for the treatment of adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. In clinical trials, participants age 18 years or more with insomnia treated with lemborexant (5 mg or 10 mg) vs placebo had statistically significant improvements in sleep onset latency (sSOL), sleep efficiency (sEF), and wake after sleep onset (sWASO) subjective measures. In a 1-month study using polysomnographic (PSG) monitoring to objectively measure sleep changes, participants treated with lemborexant vs placebo had statistically significant improvements in latency to persistent sleep (LPS) from baseline to end of treatment. Those treated with lemborexant vs placebo also had more improvement in sleep efficiency (SEF) and wake after sleep onset (WASO), as measured by PSG.

“Insomnia disorder is a chronic condition that has a variety of potential negative impacts and long-term consequences for health and well-being,” said Russell Rosenberg, PhD, DABSM, a principal investigator in the lemborexant clinical studies and former chairman of the Board of the National Sleep Foundation. “The clinical trials provide evidence that Dayvigo may improve patients’ ability to fall asleep and stay asleep.”

The most common adverse reaction (reported in 5% or more of participants treated with lemborexant and at least twice the rate of placebo) was somnolence (lemborexant 10 mg, 10%; lemborexant 5 mg, 7%; placebo, 1.0%). The most common adverse reactions leading to discontinuation of lemborexant were somnolence (lemborexant 10 mg, 1.0%; lemborexant 5 mg, 0.7%; placebo, 0.4%) and nightmares (lemborexant 10 mg, 0.3%; lemborexant 5 mg, 0.3%; and placebo, 0%).

In addition to these pivotal trials, a number of studies were conducted to further evaluate the safety of lemborexant, including effects on driving, postural stability, and memory performance. There were no meaningful differences between lemborexant (5 mg or 10 mg) and placebo on ability to awaken to sound. Nighttime dosing of lemborexant 5 mg and 10 mg resulted in balance impairment measured by body sway area at 4 hours compared with placebo. Lemborexant was associated with dose-dependent worsening on measures of attention and memory as compared with placebo. Participants should be cautioned about the potential for middle-of-the-night postural instability and possible effects on attention and memory impairment.

Although lemborexant at doses of 5 mg and 10 mg did not cause statistically significant impairment in next-morning driving performance in adult or elderly subjects (compared with placebo), driving ability was impaired in some who took 10 mg of lemborexant. People using the 10-mg dose should be cautioned about the potential for next-morning driving impairment because there is individual variation in sensitivity to lemborexant.

In 12-month and 1-month controlled safety and efficacy trials, lemborexant was not associated with rebound insomnia following treatment discontinuation. Withdrawal effects were also assessed by the Tyrer Benzodiazepine Withdrawal Symptom Questionnaire following discontinuation from study drug in participants who received lemborexant 5 mg or 10 mg. There was no evidence of withdrawal effects following lemborexant discontinuation at either dose.

The FDA has recommended to the Drug Enforcement Administration (DEA) that lemborexant be classified as a controlled substance. 

“We believe the approval of Dayvigo is particularly exciting because it is the first FDA-approved medication to report safety data over a 12 month period along with sleep onset and sleep maintenance efficacy data over a 6 month period in a pivotal clinical study,” said Lynn Kramer, MD, chief clinical officer, Neurology Business Group, Eisai. “We look forward to making this new therapeutic option available to the millions of patients who suffer with insomnia.”

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Chen Zhao, MD; Claire Flaherty, PhD; Paul J. Eslinger, PhD; and Krishnankutty Sathian, MBBS, PhD