Lemborexant

What is Lemborexant?

• Lemborexant (DAYVIGO) is an orexin receptor antagonist used for the treatment of adult patients with insomnia.

What are the uses of this medicine?

• This medicine is used for adults who have trouble falling or staying asleep (insomnia).

How does this medicine work?

• The mechanism of action of lemborexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors.
• The orexin neuropeptide signaling system plays a role in wakefulness.
• Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• narcolepsy

What drug interactions can this medicine cause?

• Avoid concomitant use of DAYVIGO with Strong CYP3A inhibitors(eg: itraconazole, clarithromycin) moderate CYP3A inhibitors (eg: fluconazole, verapamil) .The maximum recommended dose of DAYVIGO with weak CYP3A inhibitors is 5 mg.
• Avoid concomitant use of DAYVIGO with Strong CYP3A inducers(eg: rifampin, carbamazepine, St. John’s wort) or moderate CYP3A inducers (eg: bosentan, efavirenz, etravirine, modafinil)
• Avoid alcohol consumption with DAYVIGO.
• Patients receiving DAYVIGO and CYP2B6 substrates(eg: Bupropion, methadone) concurrently should be monitored for adequate clinical response.

Is this medicine FDA approved?

• It was approved for use in the United States in 2019.

How should this medicine be used?

Recommended Dosage

• The recommended dosage of DAYVIGO is 5 mg taken no more than once per night, immediately before going to bed, with at least 7 hours remaining before the planned time of awakening.
• The dose may be increased to the maximum recommended dose of 10 mg based on clinical response and tolerability.

Dosage Recommendations for Patients with Hepatic Impairment

• The maximum recommended dose of DAYVIGO is 5 mg no more than once per night in patients with moderate hepatic impairment.
• DAYVIGO is not recommended in patients with severe hepatic impairment.

Administration

• Take DAYVIGO exactly as your healthcare provider tells you to take it.
• Only take DAYVIGO one time each night, right before going to bed.
• Only take DAYVIGO when you can stay in bed for a full night (at least 7 hours).
• DAYVIGO may take longer to work if you take it with or soon after a meal.
• Do not increase your dose of DAYVIGO without talking to your healthcare provider first. Call your healthcare provider if your insomnia (sleep problem) worsens or is not improved within 7 to 10 days. This may mean that there is another condition causing your sleep problem.
• If you take too much DAYVIGO, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 5 mg, 10 mg

This medicine is available in fallowing brand namesː

• DAYVIGO

What side effects can this medication cause?

The most common side effects of this medicine include:

• somnolence

DAYVIGO may cause serious side effects, including:

• temporary inability to move or talk (sleep paralysis) for up to several minutes while you are going to sleep or waking up.
• temporary weakness in your legs that can happen during the day or at night.
• complex sleep behaviors
• worsening depression and suicidal thoughts have happened during treatment with DAYVIGO.

What special precautions should I follow?

• Do not drink alcohol while taking DAYVIGO. It can increase your chances of getting serious side effects.
• Do not drive, operate heavy machinery, do anything dangerous, or do other activities that require clear thinking if you take DAYVIGO and have had less than a full night of sleep (at least 7 hours) or if you have taken more DAYVIGO than prescribed by your healthcare provider.
• You may still feel drowsy the next day after taking DAYVIGO. Do not drive or do other dangerous activities until you feel fully awake.
• Sleep paralysis, an inability to move or speak for up to several minutes during sleep-wake transitions, and hypnagogic/hypnopompic hallucinations, including vivid and disturbing perceptions, can occur with the use of DAYVIGO.
• Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake (e.g., preparing and eating food, making phone calls, having sex), have been reported to occur with the use of hypnotics such as DAYVIGO. Discontinue immediately if a complex sleep behavior occurs.
• The effect of DAYVIGO on respiratory function should be considered if prescribed to patients with compromised respiratory function.
• Worsening of depression or suicidal thinking may occur. Prescribe the lowest number of tablets feasible to avoid intentional overdosage.

What to do in case of emergency/overdose?

• DAYVIGO showed dose-dependent increases in the frequency of somnolence.

Management for overdosage:

• There is no available specific antidote to an overdose of DAYVIGO.
• In the event of overdose, standard medical practice for the management of any overdose should be used.
• In managing overdose, provide supportive care, including close medical supervision and monitoring and consider the possibility of multiple drug involvement. Consult a Certified Poison Control Center for the most up to date information on the management of overdosage (1-800-222-1222 or www.poison.org).
• The value of dialysis in the treatment of overdosage has not been determined with lemborexant.

Can this medicine be used in pregnancy?

• There are no available data on DAYVIGO use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to DAYVIGO during pregnancy. Healthcare providers are encouraged to register patients in the DAYVIGO pregnancy registry by calling 1-888-274-2378.

Can this medicine be used in children?

• The safety and effectiveness of DAYVIGO have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: lemborexant
• Inactive ingredients: hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, and magnesium stearate. The tablet film coating contains: hypromellose 2910, polyethylene glycol 8000, talc, titanium dioxide, and either ferric oxide yellow for the 5 mg tablet; or both ferric oxide yellow and ferric oxide red for the 10 mg tablet.

Who manufactures and distributes this medicine?

• Distributed by:

Eisai Inc. Woodcliff Lake, NJ 07677 DAYVIGO® is a registered trademark of Eisai R&D Management Co., Ltd. and is licensed to Eisai Inc.

What should I know about storage and disposal of this medication?

• Store DAYVIGO at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep DAYVIGO and all medicines out of the reach of children.

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• Dailymed label info on Lemborexant
• FDA Lemborexant