Consumer medicine information

Dayvigo

Lemborexant

BRAND INFORMATION

Brand name

Dayvigo

Active ingredient

Lemborexant

Schedule

SUMMARY CMI

DAYVIGO^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

▼ This medicine is new or being used differently. Please report side effects. See the full CMI for further details.

1. Why am I using DAYVIGO?

DAYVIGO contains the active ingredient lemborexant. DAYVIGO is used to treat insomnia

For more information, see Section 1. Why am I using DAYVIGO? in the full CMI.

2. What should I know before I use DAYVIGO?

Do not use if you have ever had an allergic reaction to DAYVIGO or any of the ingredients listed at the end of the CMI.

Do not take DAYVIGO if you often fall asleep at unexpected times (narcolepsy).

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use DAYVIGO? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with DAYVIGO and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use DAYVIGO?

The recommended starting dose is one 5 mg tablet once daily right before going to bed. If more help with your sleep problem (insomnia) is needed, your doctor may increase the dose to one 10 mg tablet once daily.

More instructions can be found in Section 4. How do I use DAYVIGO? in the full CMI.

5. What should I know while using DAYVIGO?

Things you should do	Remind any doctor, dentist or pharmacist you visit that you are using DAYVIGO. Call your doctor if your sleep problem (insomnia) worsens or is not better within 7 to 10 days of taking DAYVIGO.
Things you should not do	Do not give DAYVIGO to anyone else, even if they have the same sleep problem as you. Do not take DAYVIGO if you have less than 7 hours available to sleep.
Driving or using machines	Be careful driving, operating machinery or doing other activities that require complete alertness until you know how DAYVIGO affects you. DAYVIGO may cause drowsiness in some people the day after taking it.
Drinking alcohol	Do not drink alcohol while taking DAYVIGO. Alcohol can increase your chances of getting serious side effects with DAYVIGO.
Looking after your medicine	Keep DAYVIGO in a cool dry place where the temperature stays below 30°C. Keep DAYVIGO in the blister pack until it is time to take the tablet.

For more information, see Section 5. What should I know while using DAYVIGO? in the full CMI.

6. Are there any side effects?

Common (may affect up to 1 user in 10) are: sleepiness, headaches, nightmares or abnormal dreams and sleep paralysis.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.

FULL CMI

DAYVIGO^® (daye-vi'-goe)

Active ingredient(s): lemborexant

Consumer Medicine Information (CMI)

This leaflet provides important information about using DAYVIGO. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using DAYVIGO.

Where to find information in this leaflet:

1. Why am I using DAYVIGO?
2. What should I know before I use DAYVIGO?
3. What if I am taking other medicines?
4. How do I use DAYVIGO?
5. What should I know while using DAYVIGO?
6. Are there any side effects?
7. Product details

1. Why am I using DAYVIGO?

DAYVIGO contains the active ingredient lemborexant.

DAYVIGO is a medicine called a dual orexin receptor antagonist.

DAYVIGO is used to treat insomnia. Insomnia is a condition in which patients may have one or more of the following symptoms:

Difficulty falling asleep
Difficulty staying asleep (waking too often or for too long during the night)
Waking up too early and then not being able to fall back asleep
Poor sleep quality

DAYVIGO is thought to help you fall asleep and stay asleep by temporarily blocking wakefulness, allowing sleep to occur.

2. What should I know before I use DAYVIGO?

Warnings

Do not use DAYVIGO if:

You often fall asleep at unexpected times (narcolepsy).
You are allergic to lemborexant, or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

have a history of depression, mental illness, or suicidal thoughts.
have a history of drug or alcohol abuse or addiction.
have a history of a sudden onset of muscle weakness (cataplexy).
have a history of daytime sleepiness.
have lung problems or breathing problems, including sleep apnoea.
have liver problems.

Some medicines can cause dependence, especially when they are used regularly for longer than a few weeks. People who have been dependent on alcohol or other drugs in the past may have a higher chance of becoming addicted to sleep medicines. If you have been addicted to alcohol or drugs in the past, it is important to tell your doctor before starting DAYVIGO.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant. It is not known if DAYVIGO can harm your unborn baby.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

You should not take medicines such as itraconazole, clarithromycin, fluconazole, and verapamil, which may interact with DAYVIGO. Taking DAYVIGO with these medicines may increase the risk of side effects.
You should not take medicines such as bosentan, efavirenz, etravirine, modafinil, rifampin, carbamazepine, and St. John's wort which may interact with DAYVIGO. These medicines may reduce the effect of DAYVIGO.
DAYVIGO may reduce the effect of medicines such as methadone and bupropion. Your doctor may need to adjust your treatment.

Some medicines may interfere with DAYVIGO and affect how it works. DAYVIGO should not be taken with other medicines that can make you sleepy (sedatives).

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect DAYVIGO.

4. How do I use DAYVIGO?

How much to take / use

The recommended starting dose is one 5 mg tablet once daily.
If more help with your sleep problem (insomnia) is needed, your doctor may increase the dose to one 10 mg tablet once daily.
Follow the instructions provided and use DAYVIGO until your doctor tells you to stop. Your doctor will ensure you take the lowest effective dose for as short a duration as necessary.

When to take / use DAYVIGO

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).

If you forget to use DAYVIGO

DAYVIGO should be used regularly at the same time right before bedtime. If you miss your dose at the usual time, do not take DAYVIGO unless you have the opportunity to get a full night of sleep (at least 7 hours) before you must be active again. You may continue with your usual dose the following night at bedtime.

Do not take a double dose to make up for the dose you missed.

If you use too much DAYVIGO

If you think that you have used too much DAYVIGO, you may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using DAYVIGO?

Things you should do

Call your doctor straight away if:

Your sleep problem (insomnia) worsens or is not better within 7 to 10 days of taking DAYVIGO. This may mean that there is another condition causing your sleep problem.
you become pregnant while taking DAYVIGO.
you experience abnormal thoughts or behaviours, as well as worsening of depression or suicidal thoughts or actions.
you are experiencing complex sleep behaviours (such as sleep-walking, sleep driving and engaging in other activities while not fully awake).

Remind any doctor, dentist or pharmacist you visit that you are using DAYVIGO.

Things you should not do

Do not give DAYVIGO to anyone else, even if they have the same sleep problem as you.
Do not take DAYVIGO if you have less than 7 hours available to sleep.
Do not change the dosage of DAYVIGO without checking with your doctor.
Do not take DAYVIGO in larger amounts, or for longer than prescribed.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how DAYVIGO affects you.

As with other medicines used to treat insomnia, DAYVIGO may cause drowsiness in some people the day after taking it.

Do not drive or do other dangerous activities until you feel fully awake.

Drinking alcohol

Tell your doctor if you drink alcohol.

Do not drink alcohol while taking DAYVIGO. Alcohol can increase your chances of getting serious side effects with DAYVIGO.

Looking after your medicine

Keep your medicine in the blister pack until it is time to take the tablet. If you take it out of its blister pack, it may not keep well.

Keep DAYVIGO in a cool dry place where the temperature stays below 30°C.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

in the bathroom or near a sink, or
in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
sleepiness sleep paralysis: temporary inability to move or talk for up to several minutes while you are going to sleep or waking up. cataplexy: temporary weakness in your legs that can happen during the day or at night.	Speak to your doctor if you have any of these less serious side effects and they worry you.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What DAYVIGO contains

Active ingredient (main ingredient)	lemborexant
Other ingredients (inactive ingredients)	lactose monohydrate hyprolose magnesium stearate hypromellose purified talc macrogol 8000 titanium dioxide iron oxide yellow iron oxide red (10 mg)
Potential allergens	none

Do not take this medicine if you are allergic to any of these ingredients.

What DAYVIGO looks like

DAYVIGO 5 mg film coated tablet: pale yellow, round, biconvex, film coated tablets, and debossed with "5" on one side and "LЄM" on the other side. (Aust R 338631).

DAYVIGO 10 mg film coated tablet: orange, round, biconvex, film coated tablets, and debossed with "10" on one side and "LЄM" on the other side. (Aust R 338645).

Who distributes DAYVIGO

Eisai Australia Pty Ltd
Level 2, 437 St Kilda Road
Melbourne, VIC, 3004
[email protected]

This leaflet was prepared July 2021.

Published by MIMS October 2021

BRAND INFORMATION

Brand name

Dayvigo

Active ingredient

Lemborexant

Schedule

1 Name of Medicine

Lemborexant.

2 Qualitative and Quantitative Composition

Each 5 mg Dayvigo film coated tablet contains 5 mg lemborexant.
Each 10 mg Dayvigo film coated tablet contains 10 mg lemborexant.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Dayvigo 5 mg film coated tablets are pale yellow, round, biconvex, film coated tablets, and debossed with "5" on one side and "LEM" on the other side.
Dayvigo 10 mg film coated tablets are orange, round, biconvex, film coated tablets, and debossed with "10" on one side and "LEM" on the other side.

4 Clinical Particulars

4.1 Therapeutic Indications

Dayvigo is indicated for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance in accordance with latest Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria.

4.2 Dose and Method of Administration

The recommended dose of Dayvigo is 5 mg, taken no more than once per night and within a few minutes before going to bed, with at least 7 hours remaining before the planned time of awakening. If the 5 mg dose is well-tolerated but greater effect is needed, the dose can be increased to 10 mg once daily, the maximum recommended dose. Dayvigo should be used at the lowest dose and for the shortest duration as clinically indicated.
Time to sleep onset may be delayed if taken with or soon after a meal (see Section 5.2 Pharmacokinetic Properties).
Patients should be advised not to consume alcohol in combination with Dayvigo (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions; Section 5.2 Pharmacokinetic Properties).

Use with CYP3A inhibitors.

Co-administration with moderate or strong CYP3A inhibitors.

Avoid concomitant use of Dayvigo with moderate or strong CYP3A inhibitors (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions; Section 5.2 Pharmacokinetic Properties).

Co-administration with weak CYP3A inhibitors.

The maximum recommended dose of Dayvigo is 5 mg when co-administered with weak CYP3A inhibitors (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions; Section 5.2 Pharmacokinetic Properties).

Use with CYP3A inducers.

Co-administration with moderate or strong CYP3A inducers.

Avoid concomitant use of Dayvigo with moderate or strong CYP3A inducers (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions; Section 5.2 Pharmacokinetic Properties).

Special populations.

Patients with renal impairment. No dose adjustment is required in patients with mild, moderate, or severe renal impairment (see Section 5.2 Pharmacokinetic Properties).
Patients with hepatic impairment. No dose adjustment is required in patients with mild hepatic impairment. The maximum recommended dose of Dayvigo is 5 mg in patients with moderate hepatic impairment. Dayvigo is not recommended in patients with severe hepatic impairment (see Section 5.2 Pharmacokinetic Properties).
Elderly patients. There were no clinically meaningful differences in safety or effectiveness observed between elderly patients (≥ 65 years) and adult patients at the recommended doses (see Section 5.2 Pharmacokinetic Properties). No dose adjustment is required in elderly patients.
Paediatric patients. Safety and effectiveness of Dayvigo have not been established in paediatric patients (below 18 years of age). Dayvigo is not recommended in paediatric patients (see Section 5.2 Pharmacokinetic Properties).
Patients with compromised respiratory function.

Obstructive sleep apnoea.

Effects of Dayvigo on respiratory function should be considered if prescribed to patients with compromised respiratory function. In a study of 39 patients with mild obstructive sleep apnoea (apnoea-hypopnoea index > 5 and < 15 events per hour of sleep), Dayvigo did not increase the frequency of apnoeic events or decrease mean peripheral capillary oxygen saturation. In a study of 33 patients with moderate or severe obstructive sleep apnoea (apnoea-hypopnea index ≥ 15 events per hour of sleep), lemborexant did not increase the frequency of apnoeic events or decrease mean peripheral capillary oxygen saturation.
Due to study limitations, including the short duration of the study, clinically meaningful respiratory effects of Dayvigo in obstructive sleep apnoea cannot be excluded.

Chronic obstructive pulmonary disease.

In a study of 30 patients with moderate or severe chronic obstructive pulmonary disease (COPD), overall, Lemborexant did not decrease mean peripheral capillary oxygen saturation and only numerically increased the frequency of apnoeic events.
Dayvigo has not been studied in COPD patients with a FEV1 < 30% of predicted.
Clinically meaningful respiratory effects of Dayvigo in COPD cannot be excluded.

Method of administration.

Dayvigo is for oral use only.
Time to sleep onset may be delayed if taken with or soon after a meal.

4.3 Contraindications

Dayvigo, like other orexin receptor antagonists, is contraindicated in patients with narcolepsy.
Hypersensitivity to the active substance or to any of the excipients (see Section 6.1 List of Excipients).

4.4 Special Warnings and Precautions for Use

CNS depressant effects and daytime impairment.

Dayvigo, like other sleep-promoting drugs, may impair daytime wakefulness even when used as prescribed. Prescribers should advise patients about the potential for next-day somnolence. The risk of daytime impairment is increased if Dayvigo is taken with less than a full night of sleep remaining, or if a higher than the recommended dose is taken (see Section 4.2 Dose and Method of Administration). The use of Dayvigo with other drugs to treat insomnia is not recommended.
Co-administration with other CNS depressants (e.g. benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression, which can cause daytime impairment. Dosage adjustments of Dayvigo and of concomitant CNS depressants may be necessary when administered together because of potentially additive effects. CNS depressant effects may persist in some patients for up to several days after discontinuing Dayvigo.
The lowest effective dose for the patient should be used (see Section 4.2 Dose and Method of Administration).

Abuse.

In an abuse liability study conducted in recreational sedative abusers (n=39), lemborexant (10, 20 and 30 mg) produced similar effects as zolpidem (30 mg) and suvorexant (40 mg) on subjective ratings of "Drug Liking", "Overall Drug Liking", "Take Drug Again." and "Good Drug Effects" and other measures of subjective drug effects.
Abuse of Dayvigo poses an increased risk of somnolence, daytime sleepiness, impaired reaction time and impaired driving skills. Patients at risk for abuse may include those with prolonged use of Dayvigo, those with a history of drug abuse, and those who use Dayvigo in combination with alcohol or other abused drugs.

Dependence.

In both animal studies and clinical trials evaluating physical dependence, chronic administration of lemborexant did not produce withdrawal signs or symptoms upon drug discontinuation. This suggests that lemborexant does not produce physical dependence.

Use in hepatic impairment.

No dose adjustment is required in patients with mild hepatic impairment. The maximum recommended dose of Dayvigo is 5 mg in patients with moderate hepatic impairment.
Dayvigo is not recommended in patients with severe hepatic impairment (see Section 4.2 Dose and Method of Administration, Patients with hepatic impairment; Section 5.2 Pharmacokinetic Properties, Special populations, Patients with hepatic impairment).

Use in renal impairment.

No dose adjustment is required in patients with mild, moderate, or severe renal impairment (see Section 4.2 Dose and Method of Administration, Patients with renal impairment; Section 5.2 Pharmacokinetic Properties, Special populations, Patients with renal impairment).

Use in the elderly.

No clinically meaningful differences in safety or effectiveness were observed between these patients and younger patients at the recommended doses.
Of the total number of patients treated with Dayvigo (n=1418) in controlled Phase 3 studies, 491 patients were 65 years and over, and 87 patients were 75 years and over. Overall, efficacy results for patients < 65 years of age were similar compared to patients ≥ 65 years.
In a pooled analysis of Study 303 (the first 30 days) and Study 304, the incidence of somnolence in patients ≥ 65 years with Dayvigo 10 mg was higher (9.8%) compared to 7.7% in patients < 65 years. The incidence of somnolence with Dayvigo 5 mg was similar in patients ≥ 65 years (4.9%) and < 65 years (5.1%). The incidence of somnolence in patients treated with placebo was 2% or less regardless of age.

Paediatric use.

There is no experience with Dayvigo in paediatric patients. Dayvigo is not recommended for children aged less than 18 years.

Effect on laboratory tests.

In the pooled data from the two controlled studies in patients with insomnia, no clinically meaningful differences were observed between patients receiving Dayvigo and those receiving placebo in routine serum chemistry, haematology, or urinalysis parameters.

Worsening of depression/suicidal ideation.

In clinical studies of Dayvigo in patients with insomnia, the incidence of suicidal ideation or any suicidal behaviour, as assessed by questionnaire, was higher in patients receiving Dayvigo than in those receiving placebo (0.3% for Dayvigo 10 mg, 0.4% for Dayvigo 5 mg, and 0.2% for placebo).
In primarily depressed patients treated with hypnotics, worsening of depression and suicidal thoughts and actions (including completed suicides) have been reported. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional overdose is more common in this group of patients; therefore, the lowest number of tablets that is feasible should be prescribed at any one time. The emergence of any new behavioural sign or symptom of concern requires careful and immediate evaluation.

Need to evaluate for co-morbid diagnoses.

Because sleep disturbances may be the presenting manifestation of a medical and/or psychiatric disorder, treatment of insomnia should be initiated only after careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new cognitive or behavioural abnormalities may be the result of an unrecognised underlying psychiatric or medical disorder and can emerge during the course of treatment with sleep-promoting drugs such as Dayvigo.

Sleep paralysis, hypnagogic/hypnopompic hallucinations, and cataplexy-like symptoms.

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. Prescribers should explain the nature of these events to patients when prescribing Dayvigo.
Symptoms similar to mild cataplexy can occur with Dayvigo. Such symptoms can include periods of leg weakness lasting from seconds to a few minutes, can occur either at night or during the day, and may not be associated with an identified triggering event (e.g. laughter or surprise).

Complex sleep behaviours.

Complex sleep behaviours, 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. These events can occur in hypnotic-naïve as well as in hypnotic-experienced persons. Patients usually do not remember these events.
Complex sleep behaviours may occur following the first or any subsequent use of Dayvigo, with or without the concomitant use of alcohol and other CNS depressants.
Discontinue Dayvigo immediately if a patient experiences a complex sleep behaviour.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Potential for other medicinal products to affect Dayvigo.

Weak, moderate and strong CYP3A inhibitors.

Metabolism by CYP3A is the major elimination pathway of lemborexant. Co-administration of Dayvigo with moderate CYP3A inhibitors (e.g. fluconazole) or strong CYP3A inhibitors (e.g. itraconazole) increased the exposure (AUC) of lemborexant by approximately 4-fold and C_max by 1.6-fold. Other moderate and strong inhibitors of CYP3A would be expected to have similar effects on plasma levels of lemborexant. (see Section 4.2 Dose and Method of Administration; Section 5.2 Pharmacokinetic Properties).
Using a physiologically based pharmacokinetic (PBPK) model, a weak effect is predicted when weak CYP3A inhibitors (e.g. fluoxetine) are co-administered with Dayvigo. Avoid concomitant use of Dayvigo with moderate or strong CYP3A inhibitors. The recommended dose of Dayvigo is 5 mg when co-administered with weak CYP3A inhibitors (see Section 4.2 Dose and Method of Administration; Section 5.2 Pharmacokinetic Properties).

Moderate and strong CYP3A inducers.

Avoid co-administration of Dayvigo with moderate or strong CYP3A inducers. Coadministration with a strong CYP3A inducer resulted in a 97% reduction in Dayvigo systemic exposure. This may result in a decrease in efficacy (see Section 4.2 Dose and Method of Administration; Section 5.2 Pharmacokinetic Properties).

In vitro studies with transporters.

Lemborexant is a poor substrate of P-gp, but its major metabolite (M10) is a substrate of P-gp. Lemborexant and M10 are not substrates of BCRP, OATP1B1, or OATP1B3 (see Section 5.2 Pharmacokinetic Properties).

Alcohol.

Lemborexant C_max and AUC increased by 35% and 70%, respectively, when co-administered with alcohol. Lemborexant did not affect alcohol concentrations. Alcohol should not be consumed with Dayvigo (see Section 4.2 Dose and Method of Administration; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions; Section 5.2 Pharmacokinetic Properties).

Potential for Dayvigo to affect other medicinal products.

Clinical studies with substrates of CYP3A or CYP2B6.

Lemborexant induced and inhibited CYP3A4 in vitro; however, this was not seen in clinical studies as shown by the absence of a drug-drug interaction with midazolam (a CYP3A4 substrate). Lemborexant weakly induces CYP2B6 based on study with bupropion as a CYP2B6 substrate. Substrates of CYP3A and CYP2B6 can be co-administered with Dayvigo (see Section 5.2 Pharmacokinetic Properties).

In vitro studies with substrates of CYP.

In vitro, lemborexant has a potential to induce CYP3A and a weak potential to inhibit CYP3A and induce CYP2B6. Lemborexant and M10 do not have the potential to inhibit other CYP isoforms (see Section 5.2 Pharmacokinetic Properties). Lemborexant does not induce CYP2C8, CYP2C9, and CYP2C19 at clinically relevant concentrations.

In vitro studies with substrates of transporters.

Lemborexant and M10 do not have the potential to inhibit P-gp, BCRP, BSEP, OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT 2, MATE1, and MATE2-K (see Section 5.2 Pharmacokinetic Properties).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Effects on fertility in humans are unknown.
In female rats orally administered lemborexant prior to and throughout mating and continuing to gestation Day 6, effects on female fertility (irregular oestrous cycle and decreased pregnancy rate) were observed at oral doses of 100 and 1000 mg/kg/day (approximately 60 and 545 times the exposure at the MRHD based on AUC). Decreased numbers of corpora lutea, implantations, and live embryos were noted at 1000 mg/kg/day. The NOAEL of 30 mg/kg/day is approximately 12 times the MRHD based on AUC. Lemborexant did not affect fertility when administered orally to male rats at doses resulting in exposures up to approximately 138 times the MRHD based on AUC.
(Category B3)
There are no adequate and well-controlled studies in pregnant women. Dayvigo should only be used during pregnancy if the potential benefit justifies the potential risk to the foetus.
Administration of lemborexant to pregnant rats during organogenesis in 2 separate studies at oral doses of 60, 200, and 600 mg/kg/day or 20, 60, and 200 mg/kg/day resulted in growth delays, embryofetal toxicity and malformations at maternal plasma exposures that were 388 times the plasma exposure at the maximum recommended human dose (MRHD) based on AUC. The maternal exposure at the no observed adverse effect level (NOAEL) (200 mg/kg/day) was 143 times the exposure at the MRHD based on AUC.
Administration of lemborexant to pregnant rabbits during organogenesis at oral doses of 10, 30, and 100 mg/kg/day resulted in a higher incidence of skeletal variations but no embryofetal toxicity or malformations at maternal exposures up to approximately 139 times the exposure at the MRHD based on AUC. The exposure at the NOAEL (30 mg/kg/day) was 23 times the exposure at the MRHD based on AUC.
Oral administration of lemborexant (30, 100, and 300 mg/kg/day) to pregnant rats during gestation and lactation resulted in decreased body weights, femur length, and acoustic startle responses in offspring. The exposure at the NOAEL (100 mg/kg/day) was 93 times the exposure at the MRHD based on AUC.
Data from a clinical lactation study show the presence of trace quantities of lemborexant in human milk. The relevant infant dose (RID) is approximately 2% of the maximum approved adult dose of 10 mg. A milk-only lactation study was conducted in 8 healthy, adult lactating women. The mean amount of lemborexant recovered in human milk was 0.0174 mg following a 10 mg maternal dose. The mean calculated daily infant oral dosage was 0.0029 mg/kg/day based on a nominal weight of 6 kg.
There are no data on the effects of lemborexant on the breastfed infant, or the effects on milk production. Infants exposed to Dayvigo through breastmilk should be monitored for excessive sedation. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Dayvigo and any potential adverse effects on the breastfed infant from Dayvigo or from the underlying maternal condition.

4.7 Effects on Ability to Drive and Use Machines

Although Dayvigo 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 subjects taking 10 mg Dayvigo.
Patients using the 10 mg dose should be cautioned about the potential for next-morning driving impairment because there is individual variation in sensitivity to Dayvigo.

4.8 Adverse Effects (Undesirable Effects)

Clinical trials.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of Dayvigo was evaluated in 1418 adult patients with insomnia disorder (age 18 to 88 years) from two controlled efficacy trials (Study 303 and Study 304). Study 303 was a 6-month placebo-controlled trial assessing Dayvigo 5 or 10 mg once nightly, followed by a 6-month parallel-group extension period in which patients initially treated with Dayvigo continued on the same dose, and patients who received placebo were re-randomised to receive Dayvigo 5 or 10 mg once nightly. In Study 303, 434 patients were treated with Dayvigo for one year. Study 304 was a 30-day placebo- and active-controlled trial assessing Dayvigo 5 or 10 mg once nightly.

Adverse reactions resulting in discontinuation of treatment.

The incidence of discontinuation due to adverse reactions for patients treated with 5 mg or 10 mg of Dayvigo was 3.5% for 5 mg and 6.1% for 10 mg compared to 2.7% for placebo.
The most common adverse reaction leading to discontinuation was somnolence (Dayvigo 5 mg 1.1%, Dayvigo 10 mg 2.3%, placebo 0.6%).

Most common adverse reactions.

In clinical trials of patients with insomnia treated with Dayvigo 5 mg or 10 mg, the most common adverse reaction (reported in 5% or more of patients treated with Dayvigo and at a higher rate than placebo) was somnolence (Dayvigo 5 mg 6.6%, Dayvigo 10 mg 10.5%, placebo 1.6%). Dayvigo was associated with a dose-related increase in somnolence.
Table 1 shows adverse drug reactions (ADRs) by MedDRA system organ class. The frequency of the ADRs is based on pooled data from the first 30 days of the 6-month controlled period from Study 303 and the 1-month controlled efficacy study (Study 304). Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, ADRs are presented in order of decreasing seriousness. The frequency category for each adverse drug reaction is based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).

Other adverse reactions.

Sleep paralysis, an inability to move or speak for up to several minutes during sleep-wake transitions, can occur with the use of Dayvigo. In clinical trials, Dayvigo was associated with sleep paralysis: Dayvigo 5 mg 1.1% or Dayvigo 10 mg 1.6% compared to no reports for placebo.
Two events of complex sleep behaviour were reported, both in patients receiving Dayvigo 10 mg.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).
There is limited clinical experience with lemborexant overdose. In clinical pharmacology studies, healthy patients who were administered multiple doses of up to 75 mg (7.5 times the maximum recommended dose) of lemborexant showed dose-dependent increases in the frequency of somnolence. There is no available specific antidote to an overdose of lemborexant. In the event of overdose, standard medical practice for the management of any overdose should be used. A certified poison control centre should be contacted for updated information.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Lemborexant is a competitive antagonist of both orexin receptors, OX1R and OX2R, with a higher affinity for OX2R. It belongs to the pharmacologic class of orexin receptor antagonists. The orexin neuropeptide signalling system is a central promoter of wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.
Antagonism or orexin receptors may also underlie potential adverse effects such as signs of narcolepsy/cataplexy. Lemborexant administered to mice at oral doses greater than 10 mg/kg resulted in behaviour characteristic of cataplexy when presented with chocolate. Chocolate is a stimulus that has been demonstrated to increase cataplexy occurrences in narcoleptic mice.

Pharmacodynamic effects.

Cardiac electrophysiology.

The effect of lemborexant on the QTc interval using a high precision analysis was measured in multiple dose studies in human patients administered daily doses up to 75 mg. The concentration-response relationship was analysed using a linear mixed-effects model. The model-predicted QTc effect at the highest observed concentration was 1.1 msec (90% CI: - 3.49 to 5.78), indicating that a QTc prolongation effect > 10 msec could be excluded at a dose 7.5-times the maximum recommended dose. Thus, lemborexant does not prolong the QTc interval at clinically relevant doses.

Clinical trials.

Controlled clinical studies.

Dayvigo was evaluated in two clinical trials in patients with insomnia characterised by difficulties with sleep onset and/or sleep maintenance (Study E2006-G000-303 (Study 303), and Study E2006-G000-304 (Study 304)).
Study 303 was a 6-month, randomised, double-blind, placebo-controlled, multi-centre trial in adult patients age 18 or older who met Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for insomnia disorder. Patients were randomised to placebo (n=325), Dayvigo 5 mg (n=323), or Dayvigo 10 mg (n=323) once nightly. The primary efficacy endpoint was the mean change from baseline to end of treatment at 6 months for log-transformed patient-reported (subjective) sleep onset latency (sSOL), defined as the estimated minutes from the time that the patient attempted to sleep until sleep onset. Pre-specified secondary efficacy endpoints for sleep maintenance were change from baseline to end of treatment at 6 months for patient-reported sleep efficiency (sSEF) and wake after sleep onset (sWASO). sSEF is defined as the proportion of time spent asleep per time in bed. sWASO is defined as the minutes of wake from the onset of sleep until wake time. The primary and pre-specified secondary efficacy endpoints were measured by sleep diary.
The demographic characteristics of patients in Study 303 were similar across the treatment arms. Patients had a median age of 55 years (range 18 to 88) and were 68% female, 72% White, 8% Black or African American, 17% Japanese, and 3.5% other; 28% were elderly (≥ 65 years).
In Study 303, Dayvigo 5 mg and 10 mg demonstrated statistically significant superiority on the primary efficacy measure, sSOL, compared to placebo (Table 2) from the beginning of treatment (first 7 days) and as measured at the end of 6 months of treatment). Dayvigo 5 mg and 10 mg also showed statistically significant superiority in sSEF and sWASO (at the beginning of treatment and as measured at the end of 6 months of treatment).

Study 304 was a 1-month, randomised, double-blind, placebo- and active-controlled, multi-centre, parallel-group clinical trial in adult female patients age 55 and older and male patients 65 years and older who met DSM-5 criteria for insomnia disorder. Patients were randomised to placebo (n=208), Dayvigo 5 mg (n=266) or 10 mg (n=269), or zolpidem tartrate extended release (ER; n=263) once nightly.
The primary efficacy endpoint was the mean change in log-transformed latency to persistent sleep (LPS) from baseline to end of treatment (Days 29/30), as measured by overnight polysomnography (PSG) monitoring. LPS was defined as the number of minutes from lights off to the first 10 consecutive minutes of non-wakefulness. The pre-specified secondary efficacy endpoints in Study 304 were the mean change from baseline to end of treatment (Days 29/30) in sleep efficiency (SEF) and wake after sleep onset (WASO) measured by PSG. An additional prespecified key secondary endpoint compared Dayvigo 5 mg and 10 mg with zolpidem ER on wake after sleep onset in the second half of the night (WASO2H), as assessed by polysomnography.
The demographic and baseline characteristics of patients in Study 304 were similar across the treatment arms. Patients had a median age of 63 years (range 55 to 88) and were 86% female, 72% White, 25% Black or African American, and 2% other; 45% were elderly (≥ 65 years).
In Study 304, Dayvigo 5 mg and 10 mg demonstrated statistically significant superiority on the primary efficacy measure, LPS, compared to placebo at the end of month of treatment, and also across the first 2 nights of dosing (Table 3).

Examination of subgroups by age, race, and sex did not suggest differences in response to Dayvigo in either study.

Special safety studies.

Middle of the night safety in older patients (age 55 years and older). The effect of Dayvigo was evaluated in a randomised, placebo- and active-controlled trial with a scheduled awakening 4 hours after the start of the 8-hour time in bed. Postural stability, the ability to awaken in response to a sound stimulus, and attention and memory were tested following the awakening. The comparator in the study, zolpidem tartrate ER, showed a statistically significant decrease in postural stability (increased body sway) compared to both lemborexant and placebo. There were no statistical differences between lemborexant and placebo on the ability to awaken in response to sound. There were no meaningful differences between lemborexant 5 mg and placebo on measures of attention and memory.
Effects on next-day postural stability and memory. The effects of Dayvigo on next day postural stability and memory were evaluated in two randomised, placebo- and active-controlled trials in healthy subjects and insomnia patients age 55 and older.
There were no meaningful differences between Dayvigo (5 mg or 10 mg) and placebo on next-day postural stability or memory.
Effects on driving. A randomised, double-blind, placebo- and active-controlled, four-period crossover study evaluated the effects of night time administration of Dayvigo on next-morning driving performance approximately 9 hours after dosing in 24 healthy elderly subjects (≥ 65 years, median age 67 years; 14 men, 10 women) and 24 adult subjects (median age 49 years; 12 men, 12 women). The primary driving performance outcome measure was change in Standard Deviation of Lateral Position (SDLP). Testing was conducted after one night (a single dose) and after eight consecutive nights of treatment with Dayvigo. Although Dayvigo 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 subjects taking 10 mg Dayvigo. Patients using the 10 mg dose should be cautioned about the potential for next-morning driving impairment because there is individual variation in sensitivity to Dayvigo. The results of a symmetry analysis support the findings from the primary outcome.
Rebound insomnia. Rebound insomnia was assessed by comparing sleep diary-recorded sSOL and sWASO from the screening period to the two weeks following treatment discontinuation in both Study 303 (12 months) and Study 304 (1 month). Analyses of group means and the proportion of patients with rebound insomnia suggest that Dayvigo was not associated with rebound insomnia following treatment discontinuation.
Withdrawal effects. In 12-month and 1-month controlled safety and efficacy trials (Studies 303 and 304, respectively), withdrawal effects were assessed by the Tyrer Benzodiazepine Withdrawal Symptom Questionnaire following discontinuation from study drug in patients who received Dayvigo 5 mg or 10 mg. There was no evidence of withdrawal effects following Dayvigo discontinuation at either dose.
Respiratory safety.

Healthy subjects with normal respiratory function.

In a randomised, placebo-controlled, single-dose crossover study of 17 healthy adult and elderly subjects, there were no differences between placebo and Dayvigo 10 mg and 25 mg with respect to mean peripheral capillary oxygen saturation.

Patients with mild, moderate or severe obstructive sleep apnoea (OSA).

In a randomised, placebo-controlled crossover study of 39 patients with mild OSA (apnoeahypopnoea index > 5 and < 15 events per hour of sleep), overall, Dayvigo did not increase the frequency of apnoeic events or decrease mean peripheral capillary oxygen saturation when compared with placebo following single and multiple doses of 10 mg.
In a randomised, placebo-controlled crossover study of 33 patients with moderate or severe OSA, overall, lemborexant did not increase the frequency of apnoeic events or decrease mean peripheral capillary oxygen saturation following single or multiple doses of 10 mg.

Patients with moderate or severe chronic obstructive pulmonary disease (COPD).

In a randomised, placebo-controlled crossover study of 30 patients with moderate or severe COPD, overall, lemborexant did not lead to a statistically significant increase in the frequency of apnoeic events or decrease mean peripheral capillary oxygen saturation following single or multiple doses of 10 mg.
Dayvigo has not been studied in COPD patients with a FEV1 < 30% of predicted.
Clinically meaningful respiratory effects of Dayvigo in COPD cannot be excluded.
Daily functioning. In Study 303 and Study 304, the effect of Dayvigo on daily functioning was assessed by scores on the Insomnia Severity Index (ISI). For patients treated with Dayvigo, the ISI score decreased significantly compared to placebo, indicating that patients treated with Dayvigo reported improvement of functional impairment.
Sleep stages. In Study 304, sleep stages for patients treated with Dayvigo were assessed by polysomnography. Dayvigo demonstrated a significant increase in rapid eye movement (REM) sleep compared to placebo and to zolpidem tartrate ER.

5.2 Pharmacokinetic Properties

Absorption.

In healthy patients, the pharmacokinetic profile of lemborexant was examined after single doses of up to 200 mg and after once-daily administration of up to 75 mg for 14 days. Lemborexant is rapidly absorbed, with a time to peak concentration (t_max) of approximately 1 to 3 hours. Lemborexant exhibits linear pharmacokinetics with multi-exponential decline in plasma concentrations. The extent of accumulation of lemborexant at steady-state is 1.5- to 2-fold across the dose range. The effective half-life for 5 mg and 10 mg is 17 and 19 hours respectively. The plasma concentration at 9 hours after administration is approximately 10% to 13% of the C_max.
Ingestion of Dayvigo with a high-fat meal resulted in a slight decrease in the rate of absorption as demonstrated by 23% decrease in C_max and delay in t_max of 2 hours and 18% increase in total exposure AUC.

Distribution.

The volume of distribution of lemborexant is 1970 L. Plasma protein binding of lemborexant is approximately 88% in vitro and 94% in clinical samples. The blood to plasma concentration ratio of lemborexant is 0.65.

Metabolism.

Lemborexant is primarily metabolised by CYP3A4 and to a lesser extent by CYP3A5. M10 is the only major circulating metabolite (12% of parent). The contribution of this metabolite to the pharmacological activity of lemborexant is low.

Excretion.

The primary route of elimination is through the faeces, with 57.4% of radiolabelled dose recovered in the faeces and 29.1% in the urine. The percent of lemborexant excreted unchanged in the urine is negligible (< 1% dose). The effective half-life of lemborexant 5 mg and 10 mg is 17 and 19 hours respectively.

Special populations.

Age, sex, race/ethnicity and BMI.

No clinically significant differences in the pharmacokinetics of lemborexant were observed based on age, sex, race/ethnicity, or body mass index.

Elderly patients.

Based on a population pharmacokinetic analysis in patients receiving 5 or 10 mg Dayvigo once daily, apparent clearance was 26% lower in elderly (> 65 years of age). However, this effect was not clinically relevant (see Section 4.2 Dose and Method of Administration).

Paediatric patients.

No studies have been conducted to investigate the pharmacokinetics of lemborexant in paediatric patients (see Section 4.2 Dose and Method of Administration).

Patients with renal impairment.

Severe renal impairment (urinary creatinine clearance ≤ 30 mL/min/1.73 m²) increased lemborexant exposure (AUC) 1.5-fold but had no effect on C_max. No dose adjustment is required in patients with renal impairment (see Section 4.2 Dose and Method of Administration).

Patients with hepatic impairment.

Lemborexant has not been studied in patients with severe hepatic impairment. Use in this population is not recommended. Mild (Child-Pugh A) and moderate (Child-Pugh B) hepatic insufficiency increased lemborexant AUC and C_max by 1.5-fold. Terminal half-life was only increased in patients with moderate hepatic impairment (Child-Pugh B). No relationship between these findings and hepatic function was observed. No dose adjustment is required in patients with mild hepatic impairment. A maximum dose of 5 mg is recommended in patients with moderate hepatic impairment (see Section 4.2 Dose and Method of Administration).
Exposures of lemborexant in patients with hepatic and renal impairment are summarised in Figure 1.

Drug interaction studies.

The effects of other drugs on lemborexant.

The effects of other drugs on the pharmacokinetics of lemborexant (10 mg) are presented in Figure 2 as change relative to lemborexant alone (test/reference). Based on these results, drug interactions between lemborexant and strong CYP3A inducers, strong CYP3A inhibitors, and moderate CYP3A inhibitors, are clinically significant.
Using a physiologically based pharmacokinetic (PBPK) model, a weak effect is predicted when weak CYP3A inhibitors (e.g. fluoxetine) are co-administered with lemborexant. Co-administration of moderate (e.g. fluconazole) or strong (e.g. itraconazole) CYP3A inhibitors significantly increased lemborexant exposure. CYP3A inducers (e.g. rifampin) significantly decreased lemborexant exposure.
There was no evidence of an additive effect on impairing postural stability (as evidenced by body sway) when lemborexant was co-administered with alcohol; lemborexant did not impact postural stability when dosed alone. An additive negative effect on cognitive performance was observed up to 6 hours post dose when lemborexant 10 mg was co-administered with a single dose of alcohol (0.6 g/kg for females and 0.7 g/kg for males).
Co-administration of an H2 blocker (famotidine) with lemborexant decreased C_max by 27% and delayed t_max by 0.5 hours, but had no statistically significant effect on overall lemborexant exposure (AUC). A population analysis of Phase 1-3 data also showed no effect of proton pump inhibitors (PPIs) on apparent clearance of lemborexant. A pooled analysis of data from patients taking PPIs or H2 blockers in Study 303 and 304 showed that there was no effect on sleep latency or on safety parameters. Thus, lemborexant can be co-administered with gastric acid-reducing agents (PPIs or H2 blockers).
Co-administration of an oral contraceptive containing norethindrone (NE) and ethinyl estradiol (EE) with lemborexant had no statistically significant effect on lemborexant pharmacokinetics.

Effects of lemborexant on other drugs.

In vitro metabolism studies demonstrated that lemborexant and M10 have a potential to induce CYP3A and a weak potential to inhibit CYP3A and induce CYP2B6. Lemborexant and M10 do not have the potential to inhibit other CYP isoforms (CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP2E1) or transporters (P-gp, BCRP, BSEP, OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, MATE1, and MATE2-K). Lemborexant does not induce CYP2C8, CYP2C9, and CYP2C19 at clinically relevant concentrations. Lemborexant is a poor substrate of P-gp, but M10 is a substrate of P-gp. Lemborexant and M10 are not substrates of BCRP, OATP1B1, or OATP1B3 (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Specific in vivo effects of lemborexant (10 mg) on the pharmacokinetics of bupropion, oral contraceptives, and midazolam are presented in Figure 3 as a change relative to the interacting drug administered alone (test/reference). Based on these results, drug interactions between lemborexant and CYP2B6 substrates are expected to be clinically significant, but clinically, lemborexant weakly induces CYP2B6. Lemborexant is expected to have minimal effect on the pharmacokinetics of CYP2C8, CYP2C9, or CYP2C19 substrates.
Co-administration of an oral contraceptive containing norethindrone (NE) and ethinyl estradiol (EE) with lemborexant (10 mg) did not affect the C_max and AUC of NE or the C_max of EE, and increased AUC of EE by 13%. This latter small change is not considered clinically relevant.
Clinical studies with substrates of CYP3A or CYP2B6: Despite the in vitro findings, lemborexant does not induce or inhibit CYP3A4. Lemborexant weakly induces CYP2B6 (e.g. bupropion is CYP2B6 substrate). CYP3A and CYP2B6 substrates can be coadministered with lemborexant.

5.3 Preclinical Safety Data

Genotoxicity.

Lemborexant was not mutagenic in the in vitro bacterial reverse mutation (Ames) assay or in the in vitro mouse lymphoma thymidine kinase assay, and was not clastogenic in the in vivo rat micronucleus assay.

Carcinogenicity.

Lemborexant did not increase the incidence of tumours in rats treated for 2 years at oral doses of 30, 100, and 300 mg/kg/day (males) and 10, 30, and 100 mg/kg/day (females), which are > 80 times the MRHD based on AUC. Lemborexant did not increase the incidence of tumours in Tg ras H2 mice treated for 26 weeks at oral doses of 50, 150, and 500 mg/kg/day, which are estimated up to ≥ 47 times the MRHD based on AUC.

6 Pharmaceutical Particulars

6.1 List of Excipients

The film coated tablets contain the excipients lactose monohydrate, hyprolose, magnesium stearate, Opadry complete film coating system 03F42222 - ARTG PI No. 138472 (5 mg) and Opadry complete film coating system 03F43101 Orange - ARTG PI No. 138465 (10 mg).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.
Store in original container.

6.5 Nature and Contents of Container

Dayvigo 5 mg is available in PVC/aluminium blister pack containing 3 tablets or 28 tablets.
Dayvigo 10 mg is available in PVC/aluminium blister packs containing 28 tablets.
Not all pack sizes may be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Lemborexant is a white to off-white powder that is practically insoluble in water.
Chemical name: (1R,2S)-2-{[(2,4-Dimethylpyrimidin-5-yl)oxy]methyl}-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl)cyclopropanecarboxamide.
Empirical formula: C₂₂H₂₀F₂N₄O₂.
Molecular weight: 410.42 g/mol.

Chemical structure.

CAS number.

1369764-02-2.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription only medicine.

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