STEPS

New Drug Reviews

Lemborexant (Dayvigo) for the Treatment of Insomnia

 

Am Fam Physician. 2021 Feb 15;103(4):241-242.

Lemborexant (Dayvigo) is labeled for the treatment of insomnia to improve sleep onset and maintenance in adults. It is the second dual orexin receptor antagonist and blocks wake-promotion by blocking the binding of neuropeptides, orexin A, and orexin B. Lemborexant is a Schedule IV controlled substance.1

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DrugDosageDosage formCost*

Lemborexant (Dayvigo)

5 mg daily immediately before bed; titrated to 10 mg if needed

5-mg or 10-mg tablets

$290


*—Estimated lowest GoodRx price for one month of treatment based on information obtained at https://www.goodrx.com (accessed December 17, 2020; zip code: 66211).

DrugDosageDosage formCost*

Lemborexant (Dayvigo)

5 mg daily immediately before bed; titrated to 10 mg if needed

5-mg or 10-mg tablets

$290


*—Estimated lowest GoodRx price for one month of treatment based on information obtained at https://www.goodrx.com (accessed December 17, 2020; zip code: 66211).

Safety

Lemborexant has the potential for abuse, although the risk is similar to that of other insomnia medications such as zolpidem (Ambien) and suvorexant (Belsomra). It is a central nervous system depressant, and next-day impairment is possible at therapeutic doses. Rare but serious adverse effects include sleep paralysis, hallucinations, cataplexy-like symptoms, and complex sleep behaviors (e.g., walking, driving, or cooking while not fully awake). Lemborexant should be avoided in patients with sleep apnea, chronic obstructive pulmonary disease, or depression. It should not be used in patients taking other central nervous system depressants, cytochrome P450 3A4 (CYP3A4) enzyme inducers (e.g., antiepileptics, St. John's wort, barbiturates), or CYP3A4 enzyme inhibitors (e.g., antiarrhythmics, azole antifungals, macrolides, protease inhibitors). Lemborexant is contraindicated in patients with narcolepsy. It has not been studied in pregnant or breastfeeding patients, although no adverse effects were seen in animal studies.1

Tolerability

Lemborexant is generally well-tolerated, with discontinuation rates of less than 1% with short-term use (two weeks) and less than 10% with long-term use (12 months).2,3 The most common adverse effects include day time somnolence (10%), headache (6%), and abnormal dreams (2%). In clinical trials of patients without anxiety, depression, or a history of substance overuse, lemborexant did not affect next-day functioning or memory, except when taken with alcohol. Driving ability may be impaired in

Address correspondence to Morgan Adams Rhodes, PharmD, BCACP, at morgan.rhodes@uscmed.sc.edu. Reprints are not available from the author.

Author disclosure: No relevant financial affiliations.

References

show all references

1. DailyMed. Drug label information. Dayvigo–lemborexant tablet, film coated. Accessed June 28, 2020. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd...

2. Yardley J, Kärppä M, Inoue Y, et al. Long-term effectiveness and safety of lemborexant in adults with insomnia disorder: 12-month results from SUNRISE-2. Sleep Med. 2019;64(1):S263–S264.

3. Murphy P, Moline M, Mayleben D, et al. Lemborexant, a dual orexin receptor antagonist (DORA) for the treatment of insomnia disorder: results from a Bayesian, adaptive, randomized, double-blind, placebo-controlled study. J Clin Sleep Med. 2017;13(11):1289–1299.

4. Rosenberg R, Murphy P, Zammit G, et al. Comparison of lemborexant with placebo and zolpidem tartrate extended release for the treatment of older adults with insomnia disorder: a phase 3 randomized clinical trial [published correction appears in JAMA Netw Open. 2020;3(4):e206497]. JAMA Netw Open. 2019;2(12):e1918254.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

The series coordinator for AFP is Allen F. Shaughnessy, PharmD, Tufts University Family Medicine Residency Program at Cambridge Health Alliance, Malden, Mass.

A collection of STEPS published in AFP is available at http://www.aafp.org/afp/steps.

 

 

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