`
`Important Safety Information
`Full Prescribing Information
`
`About DAYVIGO (Lemborexant) CIV & Insomnia | HCP
`
`This site is intended for US Healthcare Professionals
`
`REQUEST A REP
`
`How DAYVIGO Is Thought to Work
`DAYVIGO targets the pathway that is thought to regulate wakefulness in the
`brain.1,2
`
`DAYVIGO is:
`A dual orexin receptor antagonist that is thought to treat insomnia by blocking
`orexin signals in the brain that are believed to play a role in wakefulness
`1
`
`Believed to help patients fall asleep and stay asleep during the night by blocking the
`orexin pathway—which is thought to suppress the wake drive
`1,2
`
`DAYVIGO did not interact in vitro* with most targets considered to be involved in
`sleep/wake regulation, including :
`3
`
`Binding sites for GABA and benzodiazepines on the GABAα receptor
`Serotonin
`Noradrenaline
`Histamine
`Acetylcholine
`Dopamine
`
`GABA=gamma aminobutyric acid.
`*Defined as <50% inhibition.
`
`DAYVIGO Blocks the Orexin Pathway
`
`https://www.dayvigohcp.com/about-dayvigo
`
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`EISAI EXHIBIT 1028
`
`
`
`2/1/2021
`
`____ >
`Important Safety Information
`____ >
`Full Prescribing Information
`
`About DAYVIGO (Lemborexant) CIV & Insomnia | HCP
`
`This site is intended for US Healthcare Professionals
`
`REQUEST A REP
`
`J
`
`• ~ 0 •
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`} •
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`https://www.dayvigohcp.com/about-dayvigo
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`Important Safety Information
`Full Prescribing Information
`
`About DAYVIGO (Lemborexant) CIV & Insomnia | HCP
`
`This site is intended for US Healthcare Professionals
`
`REQUEST A REP
`
`Orexin-producing neurons
`
`Orexin neuron projections
`through the brain
`
`Major wake-controlling neurons
`expressing orexin receptors
`
`Orexin
`
`DAYVIGO
`
`OX1R
`
`OX2R
`
`OX1R=orexin 1 receptor; OX2R=orexin 2 receptor.
`
`References:
`
` DAYVIGO (lemborexant) [Prescribing Information]. Woodcliff Lake, NJ: Eisai Inc.
` 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.
`JAMA Netw Open. 2019;2(12):e1918254. doi:10.1001/jamanetworkopen.2019.18254.
` Beuckmann CT, Suzuki M, Ueno T, Nagaoka K, Arai T, Higashiyama H. In vitro and in silico characterization of
`lemborexant (E2006), a novel dual orexin receptor antagonist. J Pharmacol Exp Ther. 2017;362(2):287-295.
`
`INDICATION
`DAYVIGO (lemborexant) is an orexin receptor antagonist indicated for the treatment of adult
`patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
`
`IMPORTANT SAFETY INFORMATION
`CONTRAINDICATIONS
`DAYVIGO is contraindicated in patients with narcolepsy.
`
`WARNINGS AND PRECAUTIONS
`Central Nervous System (CNS) Depressant Effects and Daytime Impairment:
`DAYVIGO can impair daytime wakefulness. CNS depressant effects may persist in some
`patients up to several days after discontinuing DAYVIGO. Prescribers should advise patients
`about the potential for next-day somnolence.
`
`https://www.dayvigohcp.com/about-dayvigo
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`Important Safety Information
`Full Prescribing Information
`
`About DAYVIGO (Lemborexant) CIV & Insomnia | HCP
`Driving ability was impaired in some subjects taking DAYVIGO 10 mg. Risk of daytime
`This site is intended for US Healthcare Professionals
`impairment is increased if DAYVIGO is taken with less than a full night of sleep remaining or
`at a higher than recommended dose. If taken in these circumstances, patients should not
`drive or engage in activities requiring mental alertness.
`Use with other classes of CNS depressants (e.g., benzodiazepines, opioids, tricyclic
`
`REQUEST A REP
`
`https://www.dayvigohcp.com/about
`
`4/5
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`
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`2/1/2021
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`Important Safety Information
`Full Prescribing Information
`
`About DAYVIGO (Lemborexant) CIV & Insomnia | HCP
`DAYVIGO is a Schedule IV controlled substance.
`This site is intended for US Healthcare Professionals
`Because individuals with a history of abuse or addiction to alcohol or other drugs may be at
`increased risk for abuse and addiction to DAYVIGO, follow such patients carefully.
`
`REQUEST A REP
`
`For more information about DAYVIGO, see full Prescribing Information.
`
`https://www.dayvigohcp.com/about-dayvigo
`
`5/5
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