BELSOMRA

Main information

  • Trade name:
  • BELSOMRA suvorexant 15mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BELSOMRA suvorexant 15mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207709
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207709

BELSOMRA suvorexant 15mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Merck Sharp & Dohme (Australia) Pty Ltd

Postal Address

North Ryde Post Business Centre,Locked Bag 2234,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

16/11/2016

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. BELSOMRA suvorexant 15mg tablet blister pack

Product Type

Single Medicine Product

Effective date

6/02/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

BELSOMRA is indicated for the treatment of insomnia, characterised by difficulties with

sleep onset and/or sleep maintenance.

Following initiation of treatment, continuation should be re-evaluated after 3 months (see

CLINICAL TRIALS and ADVERSE EVENTS for clinical trial durations).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

36 Months

Store below 25

degrees Celsius

Child resistant closure

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

3 tablets

(S4) Prescription Only Medicine

30 tablets

(S4) Prescription Only Medicine

10 tablets

(S4) Prescription Only Medicine

Components

1. BELSOMRA suvorexant 15mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, oval, biconvex, film coated tablet, marked with Merck logo and 325

on one side and plain on the other side

Active Ingredients

suvorexant

15 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 28.11.2017 at 12:09:08 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

BELSOMRA®

Suvorexant

Consumer Medicine Information Summary

This summary answers some common questions about BELSOMRA. It does not contain all the available information.

Comprehensive Consumer Medicine Information follows this summary.

What BELSOMRA is used for and How BELSOMRA works

BELSOMRA is a medicine called Orexin Receptor Antagonist. BELSOMRA is used to treat a sleep problem called insomnia,

which includes problems falling asleep and/or staying asleep. BELSOMRA helps you to go to sleep and stay asleep by

temporarily blocking wakefulness, enabling sleep to occur.

Before you take BELSOMRA

Do not take BELSOMRA if:

you fall asleep often at unexpected times (narcolepsy).

you are allergic to suvorexant or any of the other ingredients of BELSOMRA listed at the end of this leaflet.

Before starting BELSOMRA, tell your doctor about all of your health conditions, including if you:

have a history of a sudden onset of muscle weakness (cataplexy)

have a history of falling asleep often at unexpected times (narcolepsy) or daytime sleepiness

have a history of depression, mental illness, or suicidal thoughts

have a history of drug or alcohol abuse or addiction. BELSOMRA may be abused or misused

have liver disease

have a lung disease or breathing problems

Tell your doctor or pharmacist if you are pregnant or plan to become pregnant or if you are breastfeeding or plan to

breast-feed.

Your doctor will discuss with you the risks and benefits involved.

Tell your doctor or pharmacist if you are taking any other medicines, including medicines, vitamins and herbal

supplements that you buy without a prescription.

Medicines that should not be taken with BELSOMRA include but are not

limited to clarithromycin, erythromycin, fluconazole, itraconazole, diltiazem, verapamil and certain medicines to treat HIV.

How to take BELSOMRA

Take BELSOMRA exactly as your doctor tells you.

The recommended dose for non-elderly adults (younger than 65 years) is one 20 mg tablet.

The recommended dose for elderly adults (65 years or older) is one 15mg tablet.

These doses should not be exceeded. Higher doses worked similarly, but more side effects were reported.

Continue to take BELSOMRA for as long as your doctor tells you. If you require continuing treatment with

BELSOMRA after using it for 3 months, you should return to your doctor to discuss your response to the medicine.

While you are using BELSOMRA

Do not take BELSOMRA if you drank alcohol that evening or before bed.

Alcohol can increase your chances of getting

serious side effects with BELSOMRA.

Do not take BELSOMRA if you take other medicines that can make you sleepy.

Be careful driving, operating machinery or other activities that require complete alertness until you know how

BELSOMRA affects you.

As with other medicines used to treat insomnia, BELSOMRA may cause drowsiness in some

people the day after taking it. Do not drive or do other dangerous activities until you feel fully awake.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking BELSOMRA.

medicine may have unintended or undesirable effects, so-called side effects.

Stop taking BELSOMRA and tell your doctor immediately if you notice any of the following:

abnormal thoughts and behaviour

. Symptoms include more outgoing or aggressive behaviour than normal, confusion,

agitation, hallucinations (including vivid and disturbing perceptions)

worsening of depression and suicidal thoughts or actions

temporary inability to move or talk (sleep paralysis)

for up to several minutes while you are going to sleep or waking

BELSOMRA®

BELSOMRA®

Suvorexant

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about BELSOMRA. It

does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking BELSOMRA

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What BELSOMRA is

used for

BELSOMRA is a medicine called an

Orexin Receptor Antagonist.

BELSOMRA is used to treat a sleep

problem called insomnia, which

includes problems falling asleep

and/or staying asleep.

Insomnia

Insomnia is a condition in which

patients may have 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

How BELSOMRA works

BELSOMRA helps you to go to

sleep and stay asleep by temporarily

blocking wakefulness, enabling sleep

to occur.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

There is no experience with

BELSOMRA in children or

adolescents under 18 years of age.

Do not give BELSOMRA to a child

or adolescent.

Before you take

BELSOMRA

When you must not take it

Do not take BELSOMRA if you

fall asleep often at unexpected

times (narcolepsy).

Do not take BELSOMRA if you

are

allergic

to

suvorexant

or

any of the other ingredients of

BELSOMRA listed at the end

of this leaflet.

The packaging is torn or shows

signs of tampering.

The expiry date on the pack has

passed.

If you take this medicine after the

expiry date has passed, it may not

work.

If you are not sure whether you

should start taking BELSOMRA,

talk to your doctor.

Before you start to take it

BELSOMRA may not be right for

you. Before starting BELSOMRA,

tell your doctor about all of your

health conditions, including if you:

have a history of a sudden

onset of muscle weakness

(cataplexy)

have a history of falling asleep

often

unexpected

times

(narcolepsy)

daytime

sleepiness

have

history

depression,

mental

illness,

suicidal

thoughts

have

history

drug

alcohol

abuse

addiction.

BELSOMRA may be abused or

misused

have liver disease

have a lung disease or breathing

problems

After

taking

BELSOMRA,

you

may get up out of bed while not

being

fully

awake

and

do

an

activity that you do not know you

are doing, such as sleep-walking,

eating, talking, or driving a car.

The

next

morning,

you

may

not

remember that you did anything

during the night.

You have a higher

chance for doing these activities if

drink

alcohol

take

other

medicines that make you sleepy with

BELSOMRA.

Tell

your

doctor

immediately

if

you find out that you have done

any unusual activities after taking

BELSOMRA.

You should contact your doctor if

you experience abnormal thoughts

and behaviours

such as worsening

of

depression,

and

suicidal

thoughts or actions.

Tell your doctor or pharmacist if

you:

are pregnant or plan to

become pregnant.

It is not

known if BELSOMRA can

harm your unborn baby.

BELSOMRA®

Your doctor will discuss with

risks

benefits

involved.

are

breast-feeding.

known if BELSOMRA passes

into your breast milk.

Your doctor will discuss with

you the risks and benefits

involved.

have allergies to any other

medicines, foods,

preservatives or dyes.

If you have not told your doctor

about any of the above, tell

him/her before you take any

BELSOMRA.

Taking other medicines

Tell your doctor or pharmacist if you

are taking any other medicines,

including medicines, vitamins and

herbal supplements that you buy

without a prescription.

Medicines can interact with each

other, sometimes causing serious side

effects.

BELSOMRA should not be taken

with some medicines because it

strongly affects the level of either

BELSOMRA or the other medicine

in the blood.

Medicines that should not be taken

with BELSOMRA include but are

not limited to clarithromycin,

erythromycin, fluconazole,

itraconazole, diltiazem, verapamil,

and certain medicines to treat HIV.

Do not take BELSOMRA with

other medicines that can make you

sleepy.

Talk to your doctor about all of your

medicines. Your doctor will tell you

if you can take BELSOMRA with

your other medicines.

How to take

BELSOMRA

Follow all directions given to you

by your doctor and pharmacist

carefully.

If you do not understand the

directions, ask your doctor or

pharmacist for help.

How much to take

Take BELSOMRA exactly as your

doctor tells you.

For dosage in non-elderly adults

(<65 years) and elderly adults (≥65

years):

The recommended dose for non-

elderly adults (younger than 65

years) is one 20 mg tablet.

recommended

dose

elderly adults (65 years or older)

is one 15mg tablet.

These

doses

should

exceeded. Higher doses worked

similarly, but more side effects

were reported

The safety and effectiveness of

BELSOMRA is similar in older and

younger patients at the recommended

doses.

How to take it

BELSOMRA may be taken with

or without food.

Swallow the tablet whole with a

full glass of water.

When to take it

Only take BELSOMRA 1 time

each night within 30 minutes

of going to bed.

Take BELSOMRA only when

you have the opportunity for a

full night of sleep (at least 7

hours) before you must be

active again.

If you are not sure when to take it,

ask your doctor or pharmacist.

How long to take it

Continue to take BELSOMRA for

as long as your doctor tells you.

After starting BELSOMRA, your

doctor will periodically reassess

your need to continue treatment

with BELSOMRA.

Ask your doctor or pharmacist if

you are not sure how long to take

the medicine.

If you forget to take it

If you miss a dose, do not take

BELSOMRA 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.

If you are not sure what to do, ask

your doctor.

If you take too much

(overdose)

Immediately telephone your doctor

or Poisons Information Centre

(telephone 131 126), or go to

accident and emergency at your

nearest hospital, if you think that

you or anyone else may have taken

too much BELSOMRA. Do this

even if there are no signs of

discomfort or poisoning.

While you are using

BELSOMRA

Things you must do

Call your doctor if your insomnia

(sleep problem) worsens or is not

better within 7 to 10 days of taking

BELSOMRA. This may mean that

there is another condition causing

your sleep problem.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking BELSOMRA.

Tell any other doctors, dentists and

pharmacists who treat you that

you are taking BELSOMRA.

If you become pregnant while

taking BELSOMRA, tell your

doctor immediately.

BELSOMRA®

Things you must not do

Do

not

take

BELSOMRA

if

you drank alcohol that evening

or

before

bed.

Alcohol

increase your chances of getting

serious

side

effects

with

BELSOMRA.

Do

not

take

BELSOMRA

if

you take other medicines that

can make you sleepy. Talk to

your doctor about all of your

medicines.

Your

doctor

will

tell

you

if

you

can

take

BELSOMRA with your other

medicines.

Do

not

give

BELSOMRA

to

anyone else, even if they have

the same condition as you.

Things to be careful of

Be careful driving, operating

machinery or other activities that

require complete alertness until

you know how BELSOMRA

affects you.

As with other medicines used to treat

insomnia, BELSOMRA may cause

drowsiness in some people the day

after taking it.

Do not drive or do

other dangerous activities until you

feel fully awake.

Side Effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

BELSOMRA.

Any medicine may have unintended

or undesirable effects, so-called side

effects.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice or

have any of the following and they

worry you:

sleepiness

tiredness

headache

dizziness

upper respiratory tract infection

diarrhoea

dry mouth

nausea

unusual dreams including

nightmare

making mistakes in taking your

medicine.

These are the more common side

effects of your medicine.

Other less common side effects of

BELSOMRA include:

memory loss

anxiety

temporary weakness in your legs

that can happen during the day or

at night.

cough

Stop taking BELSOMRA and tell

your doctor immediately if you

notice any of the following:

abnormal thoughts and

behaviour

. Symptoms include

more outgoing or aggressive

behaviour than normal,

confusion, agitation,

hallucinations (including vivid

and disturbing perceptions)

worsening of depression and

suicidal thoughts or actions

temporary inability to move

or talk (sleep paralysis)

for up

to several minutes while you

are going to sleep or waking up.

Other side effects not listed above

may also occur in some patients and

as with any prescription drug, some

side effects may be serious.

Tell your doctor if you notice any

other effects.

After using

BELSOMRA

Storage

Keep your tablets in the blister

pack until it is time to take them.

If you take the tablets out of the

blister pack they may not keep well.

Keep BELSOMRA in a cool dry

place where the temperature stays

below 25 degrees Celsius. Do not

store it or any other medicine in

the bathroom or near a sink.

Do not leave it in the car or on

window sills.

Heat and dampness can destroy some

medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop

taking BELSOMRA or the tablets

have passed their expiry date, ask

your pharmacist what to do with

any that are left over.

Product description

What it looks like

BELSOMRA comes as two strengths

of tablets:

15 mg tablet - A white, oval,

biconvex, film coated tablet,

marked with "

" on one side and

325 on the other.

20 mg tablet - A white, round,

biconvex, film coated tablet,

marked with "

" and 335 on one

side, and plain on the other.

A box of BELSOMRA contains

10* tablets or 30 tablets.

BELSOMRA tablets may also be

supplied in packs of 3 tablets to

start treatment.

* Not currently supplied in Australia

BELSOMRA®

Ingredients

Active ingredient:

Suvorexant 15 or 20 mg per tablet

Inactive ingredients:

Copovidone

Microcrystalline cellulose

Lactose

Croscarmellose sodium

Magnesium stearate

Ingredients of film-coating:

Lactose

Hypromellose

Titanium dioxide

Glycerol triacetate

BELSOMRA does not contain

gluten, sucrose, tartrazine or any

other azo dyes.

Supplier

BELSOMRA is supplied in Australia

Merck Sharp & Dohme (Australia)

Pty Limited

Level 1, Building A,

26 Talavera Road

MACQUARIE PARK NSW 2113

Date of Preparation

This leaflet was prepared in Dec

2016.

Australian Register Numbers:

15 mg tablet - AUST R 207709

20 mg tablet - AUST R 207712

This CMI leaflet was current at the

time of printing. To check if it has

been updated, please view our

website www.msd-australia.com.au

or ask your pharmacist.

(S-CCPPI-MK4305-T-112015)

BELSOMRA®

20-3-2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

First-generation oral sedating antihistamines – use in children, Suvorexant (Belsomra) – next day effects, Desvenlafaxine (Pristiq) recommended dose, Miconazole and potential interaction with warfarin

Therapeutic Goods Administration - Australia

There are no news related to this product.