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ZOLPIDEM TARTRATE 5 MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Zolpidem tartrate 5 mg film-coated tablets
Zolpidem tartrate 10 mg film-coated tablets
Zolpidem tartrate
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
their symptoms are same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Zolpidem tartrate is and what it is used for
2. Before you take Zolpidem tartrate
3. How to take Zolpidem tartrate
4. Possible side effects
5. How to store Zolpidem tartrate Tablets
6. Further information
1.

What Zolpidem tartrate is and what it is used for

Zolpidem is a hypnotic belonging to the group of benzodiazepine-like agents. It is used for short-term
treatment of sleep disturbances.
Treatment with benzodiazepines and benzodiazepine-like agents is only indicated for serious sleep
disturbances.
2.

Before you take Zolpidem tartrate

DO NOT take Zolpidem tartrate if
• you are allergic (hypersensitive) to zolpidem tartrate or any of the other ingredients of Zolpidem
tartrate tablets
• you suffer from a condition in which your muscles are weak and tire easily (myasthenia gravis)
• you have difficulty breathing (respiratory insufficiency)
• you suffer from difficulty breathing while asleep (sleep apnoea syndrome)
• you suffer from severe liver damage (hepatic insufficiency).
• you are under the age of 18
Warnings and precautions
Next-day psychomotor impairment (see also Driving and using machines)
The day after taking Zolpidem tartrate, the risk of psychomotor impairment, including impaired
driving ability may be increased if:


You take this medicine less than 8 hours before performing activities that require your
alertness



You take a higher dose than the recommended dose



You take zolpidem while you are already taking another central nervous system depressants or
another medicines that increase zolpidem in your blood, or while drinking alcohol, or while
taking illicit substances

Take the single intake immediately at bedtime.

Do not take another dose during the same night.
Take special care with Zolpidem tartrate
Please tell your doctor if:
• you suffer from chronic shortness of breath (dyspnoea)
• you have a history drug or alcohol abuse
• you have a history of psychotic illness
• you are depressed, think you are depressed or are being treated for depression. Zolpidem tartrate
may unmask or worsen pre-existing symptoms
• you are elderly
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking
Zolpidem tartrate.
If after a few weeks you notice that the tablets are not working as well as they did when you first
started taking them, you should go and see your doctor as an adjustment to your dosage may be
required.
When taking this medicine there is a risk of dependence (a need to keep taking the medicine). The risk
increases with the dose and length of treatment period. The risk is greater if you have ever had a
history of alcohol or drug abuse.
When stopping this medicine you may experience side effects called withdrawal symptoms or
experience a condition called rebound insomnia, see section 3 (If you stop taking Zolpidem tartrate).
Taking other medicines
Please tell to your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
It is especially important to tell your doctor if you are taking the following medicines in combination
with Zolpidem tartrate as they may increase the effect of both medications on the central nervous
system:
• medicinal products to treat mental disorders (neuroleptics, antidepressants, antipsychotics)
• other medicinal products to treat sleep disturbances
• medicinal products against anxiety disorders, sedatives (anxiolytics/tranquillizers)
• highly effective analgesics (narcoanalgesics). Increased euphoria may occur which can result in
increased psychological dependence.
• muscle relaxants
• medicinal products against seizures (antiepileptics)
• anaesthetics
• medicinal products to treat allergies or common colds with concurrent sedative effect (sedative
antihistamines).
• ketoconazole (a potent CYP3A4 inhibitor)
While taking zolpidem with the following medicines, drowsiness and next-day psychomotor
impairment effects, including impaired driving ability, may be increased.


Medicines for some mental health problems (antipsychotics)



Medicines for sleep problems (hypnotics)



Medicines to calm or reduce anxiety



Medicines for depressions



Medicines for moderate to severe pain (narcotic analgesics)



Medicines for epilepsy



Medicines used for anesthesia



Medicines for hay fever, rashes or other allergies that can make you sleepy (sedatives
antihistamines)

While taking zolpidem with antidepressants including bupropion, desipramine, fluoxetine, sertraline
and venlafaxine, you may see things that are not real (hallucinations)
It is not recommended to take zolpidem with fluvoxamine or ciprofloxacin.
It is especially important to tell your doctor if you are taking the following medicines in combination
with Zolpidem tartrate as they may decrease the action of Zolpidem tartrate:
Medicinal products enhancing the activity of certain liver enzymes e. g. rifampicin (for treatment of
tuberculosis).
Taking Zolpidem tartrate with food and drink
Do not use any alcohol during treatment, as this will change and intensify the effect of zolpidem
tartrate in an unforeseeable way. The ability to perform tasks that demands an increased concentration
is additionally impaired by this combination.
Pregnancy and breast-feeding
Do not take Zolpidem tartrate during pregnancy or if you are breast feeding
Please inform your doctor if you want to become pregnant during treatment with Zolpidem tartrate or
if you suspect to be pregnant, so that he/she can decide whether treatment is to be continued or e.g.
converted.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive or use machines while taking if you experience sleepiness, memory defects, impaired
concentration or impaired muscular function . This applies to a higher degree if you are not getting
enough sleep.
Zolpidem tartrate has major influence on the ability to drive and use machines such as “sleep driving”.
On the day after taking Zolpidem tartrate (as other hypnotic medicines), you should be aware that:


You may feel drowsy, sleepy, dizzy or confused



Your quick decision-making may be longer



Your vision may be blurred or double



You may be less alert

A period of at least 8 hours is recommended between taking zolpidem and driving, using machinery
and working at heights to minimize the above listed effects.
Do not drink alcohol or take other psychoactive substances while you are taking Zolpidem tartrate, as
it can increase the above listed effects
Important information about some of the ingredients of Zolpidem tartrate
Zolpidem tartrate tablet contain lactose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
3.

How to take Zolpidem tartrate

Always take Zolpidem tartrate exactly as your doctor has told you. You should check with your doctor
or pharmacist if you are not sure.

The recommended dose per 24 hours is 10 mg of Zolpidem tartrate. A lower dose may be prescribed
to some patients. Zolpidem tartrate should be taken:


as a single intake,



just before bedtime

Make sure you have a period of at least 8 hours after taking this medicine before performing activities
that require your alertness.
Do not exceed 10mg per 24 hours.
Taking this medicine
• Take this medicine by mouth
• Swallow the tablet whole with a drink of water
• Take just before bedtime. Make sure you have at least 7-8 hours for sleep after taking this
medicine
• The usual length of treatment is 2 days to 4 weeks
Adults
The recommended daily dose is 10 mg zolpidem tartrate, just before bedtime.
Elderly and debilitated patients
A dose of 5 mg zolpidem tartrate/day is recommended. This dosage should be exceeded only in
exceptional cases.
Patients with impaired liver function
In patients with impaired liver function a dose of 5 mg zolpidem tartrate/day is recommended.
Children and adolescents
Zolpidem tartrate must not be used in children and adolescents of less than 18 years of age.
A daily dose of 10 mg should not be exceeded.
If you take more Zolpidem tartrate than you should
In case of overdose, a doctor's advice is to be asked without delay.
In case of overdose of Zolpidem tartrate alone, depression of consciousness has been reported which
was in the range from extreme sleepiness up to light coma.
Besides visual disturbances, twisting and repetitive movements or abnormal posture due to involuntary
muscle contractions and spasm, movement disorders and paradoxical reactions (restlessness,
hallucinations) may occur.
If you forget to take Zolpidem tartrate
DO NOT take a double dose to make up for a forgotten dose. Continue intake of Zolpidem tartrate as
prescribed by your doctor.
If you stop taking Zolpidem tartrate
Keep taking Zolpidem tartrate until your doctor tells you to stop. Do not stop taking Zolpidem tartrate
suddenly, but tell your doctor if you want to stop. Your doctor will need to lower your dose and stop
your tablets over a period of time.
When stopping this medicine you may experience side effects called withdrawal symptoms.
These include:
• headache or muscle pain
• extreme anxiety and tension
• restlessness






mood changes
confusion
irritability
sleep disturbances

In severe cases
• a feeling of things being unreal (derealisation or depersonalization)
• sounds seeming louder than usual that can be painful (hyperacusis)
• numbness and tingling of extremities
• hypersensitivity to light, noise and physical contact
• hallucinations
• epileptic seizures
You may also experience a condition called rebound insomnia when stopping this medicine. This is an
inability to sleep which may be worse than the insomnia you had before you started treatment. You
may also experience mood changes, anxiety and restlessness.
The risk of withdrawal symptoms and rebound insomnia is greater if you stop taking this medicine
suddenly. Therefore your doctor may decide to gradually reduce the dose you take before you stop
taking this medicine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines, Zolpidem tartrate can cause side effects, although not everybody gets them.
Stop taking Zolpidem tartrate and see a doctor or go to a hospital straight away if:
• You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue.
Tell your doctor as soon as possible if you have any of the following side effects:
Common (affects less than 1 in 10 people)
• Poor memory while taking Zolpidem tartrate (amnesia) and strange behaviour during this time.
This is more likely to affect you in the few hours after you take this medicine. By having 7-8
hours sleep after taking Zolpidem tartrate, this is less likely to cause you a problem.
• Sleeping problems that get worse after taking this medicine
• Seeing or hearing things that are not real (hallucinations)
Uncommon (affects less than 1 in 100 people)
• Blurred eyesight or ‘seeing double’
Frequency unknown
• Being less aware of your environment
• Falling, especially in the elderly
Sleep-Driving and other strange behaviour
There have been some reports of people doing things while asleep that they do not remember when
waking up after taking a sleep medicine.
This includes sleep-driving, sleep walking and having sex. Alcohol and some medicines for depression
or anxiety can increase the chance that this serious effect will happen.
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than
a few days:

Common (affects less than 1 in 10 people)
• Diarrhoea
• Headache
• Feeling tired or agitated
• Nightmares
Uncommon (affects less than 1 in 100 people)
• Feeling confused or irritable
Frequency unknown
• Itching skin or skin rash
• Weak muscles
• Feeling restless, aggressive, angry or showing unusual behaviour
• Thinking things that are not true (delusions)
• Changes in sex drive (libido)
• Change in the amount of liver enzymes – shown up in the results of blood tests
• Changes in the way you walk
• Zolpidem tartrate having less effect than normal
Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few
days, or if you notice any side effects not listed in this leaflet
5.

How to store Zolpidem tartrate Tablets

Keep out of the reach and sight of children.
Do not use Zolpidem tartrate after the expiry date, which is stated on the blister/bottle and the carton
after EXP. The expiry date refers to the last date of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed off via wastewater or household waste. Ask your pharmacist how to
dispose off medicines no longer required. These measures will help to protect the environment.
6.

Further information

What Zolpidem tartrate contains
- The active substance is zolpidem tartrate.
One film-coated tablet contains 5 mg zolpidem tartrate equivalent to 4.02 mg zolpidem.
One film-coated tablet contains 10 mg zolpidem tartrate equivalent to 8.04 mg zolpidem.
- The other ingredients are:
Tablet core: Lactose monohydrate, cellulose microcrystalline, sodium starch glycolate (Type A),
magnesium stearate.
Tablet film-coating: hypromellose, macrogol 400, titanium dioxide (E 171)
What Zolpidem tartrate looks like and contents of the pack
Film-coated tablet.
Zolpidem tartrate 5 mg film-coated tablets are white to off-white, circular, biconvex, debossed with
‘E’ on one side and ‘78’ on other side.
Zolpidem tartrate 10 mg film-coated tablets are white to off-white, oval shaped, biconvex, debossed
with ‘E’ on one side and ‘80’ with a score line between ‘8’ and ‘0’ on other side. The tablet can be
divided into equal halves.
Blister

Pack sizes: 4, 5, 7, 8, 10, 14, 15, 20, 25, 28, 30, 40, 50, 56, 60, 70, 80, 84, 90, 98, 100, 105, 112, 150,
250 and 500 film-coated tablets.
HDPE bottle:
Pack sizes: 30, 50, 100, 250 and 500 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
This leaflet was last revised in 07/2014

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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