Zolpidem Tartrate 5mg Tablets

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect.

1. What zolpidem is and what it is used for
2. What you need to know before you take zolpidem
3. How to take zolpidem
4. Possible side effects
5. How to store zolpidem
6. Contents of the pack and other information

• You are allergic (hypersensitive) to zolpidem tartrate or any of the other ingredients of this medicine (listed in section 6).
  Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• You have a problem where you stop breathing for short periods at night (sleep apnoea).
• You have a problem that causes severe muscle weakness (myasthenia gravis).
• You have breathing difficulties (hypoventilate).
• You have severe liver problems.
• You have been told by a doctor that you have a mental illness (psychosis).
• You are under the age of 18.

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking zolpidem.

Talk to your doctor or pharmacist before taking zolpidem if:

• You are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs, or if you have ever had a history of struggling to control your alcohol or drug intake .
• You have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
• You feel the need to take more zolpidem to get the same level of symptom control, this may mean you are developing tolerance to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative medication
• Your lungs do not work properly.
• You have any liver problems.
• You have depression or have had another mental illness in the past.
• You have recently taken zolpidem or other similar medicines for more than 4 weeks.

Taking this medicine regularly, particularly for a long time, can lead to physical dependence and addiction. Your prescriber should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months.

The risk of dependence is greater when zolpidem is used for longer than 4 weeks, and in patients with a history of mental disorders and/or alcohol, illicit substance or drug abuse. Tell your healthcare provider if you have ever had a mental disorder or have abused or have been dependent on alcohol, substance or drugs.

Physical dependence and addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include:

• feeling anxious, shaky, irritable, agitated, confused, having panic attacks, sweating, headache, faster heartbeat or uneven heartbeat (palpitations), lower level of awareness or problems with focussing or concentrating, nightmares, seeing of hearing things that are not real (hallucinations), being more sensitive to light, noise and touch than normal, relaxed grip on reality, numbness and tingling in your hands and feet, aching muscles, stomach problems.

Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.

Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

Z-drugs should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of Z-drugs, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

Some studies have shown an increased risk of suicidal ideation, suicide attempt and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been established whether this is caused by the medicine or if there may be other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for further medical advice.

Zolpidem can cause drowsiness and decrease your level of alertness. This could cause you to fall, sometimes leading to severe injuries.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking zolpidem.

The day after taking zolpidem, 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 recommended.
• You take zolpidem while you are already taking other central nervous system depressants or other 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.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because zolpidem can affect the way some other medicines work. Also some medicines can affect the way zolpidem works.

Zolpidem may increase the effect of the following medicines:

While taking zolpidem with the following medicines, drowsiness and next-day psychomotor impairment effects, including impaired driving ability, may be increased:

• Medicines for mental problems (antipsychotics).
• Medicines for depression such as sertraline.
• Some medicines for moderate to severe pain (narcotic analgesics).
• Medicines for epilepsy (anticonvulsants).
• Medicines used in surgery (anaesthetics).
• Medicines to calm or reduce anxiety or for sleep problems (hypnotics).
• Medicines for hay fever, rashes or other allergies that can make you sleepy (sedative antihistamines) such as chlorphenamine or promethazine.

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, ciprofloxacin or St. John’s Wort (a herbal medicine) used for mood swings and depression.

Risks from concomitant use with opioids

Concomitant use of zolpidem and opioids (strong pain killers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However if your doctor does prescribe zolpidem together with opioids the dosage and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all opioid medicines you are taking, and follow your doctor’s dosage recommendation closely. It could be helpful to inform friends or relatives to be aware of sign and symptoms stated above. Contact your doctor when experiencing such symptoms.

The following medicines can increase the chance of you getting side effects when taken with zolpidem. To make this less likely, your doctor may decide to lower your dose of zolpidem:

• Some medicines for fungal infections such as ketaconazole.

The following medicines can make zolpidem work less well:

• Rifampicin (an antibiotic) – for infections.

Do not drink alcohol while you are taking zolpidem. Alcohol can increase the effects of zolpidem and make you sleep very deeply so that you do not breathe properly or have difficulty waking.

Pregnancy

Use of this medicine is not recommended during pregnancy.

If you discover that you are pregnant or are planning to have a baby, consult your doctor right away to re-assess the need for treatment.

A large amount of data has not shown evidence of malformations with benzodiazepines. However, some epidemiological studies have shown a potentially increased risk of cleft lip and palate in newborn babies compared to that in the general population.

Cleft lip and palate (sometimes called “harelip”) is a deformation at birth caused by incomplete fusion of the palate and upper lip.

Reduced fetal movement and fetal heart rate variability may occur after taking zolpidem during the second and/or third trimester of pregnancy.

If taken at the end of pregnancy muscle weakness (hypotonia), a drop in body temperature (hypothermia), difficulty feeding (problems suckling causing poor weight gain) and breathing problems (respiratory depression) may occur in the newborn.

If taken regularly in late pregnancy, your baby may get withdrawal symptoms. In this case the newborn should be closely monitored during the postnatal period.

Breast-feeding

Do not take zolpidem if you are breast-feeding or planning to breast-feed. This is because small amounts may pass into mothers’ milk.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

On the day after taking zolpidem, do not drive or use machinery or tools if you feel sleepy, dizzy or confused. Zolpidem has a major influence on the ability to drive and use machines such as ‘sleep driving’. On the day after taking zolpidem (as with other hypnotic medicines), you should be aware that:

• You may feel drowsy, sleepy, dizzy or confused.
• You may take longer to make quick decisions.
• You may have double or blurred vision.
• 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 as it can increase the above listed effects.

This medicine contains Lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before having this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’

• Take this medicine by mouth.
• Swallow the tablet whole with a drink of water.
• The recommended dose per 24 hours is 10mg of zolpidem. A lower dose may be prescribed to some patients.
• Zolpidem 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.
• The usual length of treatment is 2 days to 4 weeks.

Adults

• The recommended dose is one 10mg tablet (or two 5mg tablets) just before bedtime. A lower dose may be prescribed to some patients.

Elderly

• The usual dose is one 5mg tablet just before bedtime.

Patients with liver problems

• The usual starting dose is one 5mg tablet just before bedtime. This may be increased to two 5mg tablets (or one 10mg tablet) by your doctor if necessary.

Children and adolescents

Do not give this medicine to children under 18 years old.

• Zolpidem can change the levels of liver enzymes shown up in blood tests. This can mean that your liver is not working properly.
• If you are going to have a blood test, it is important to tell your doctor that you are taking zolpidem.

If you take more zolpidem than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.

Taking too much zolpidem can be very dangerous. The following effects may happen:

• Feeling drowsy, confused, sleeping deeply and possibly falling into a coma.

Zolpidem must only be taken at bedtime. If you forget to take your tablet at bedtime, then you should not take it at any other time, otherwise you may feel drowsy, dizzy and confused during the day. Do not take a double dose to make up for a forgotten tablet.

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. This may occur over a period of weeks to months. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

Withdrawal symptoms such as:

• feeling anxious, shaky, irritable, agitated, confused, having panic attacks, sweating, headache, faster heartbeat or uneven heartbeat (palpitations), lower level of awareness or problems with focussing or concentrating, nightmares, seeing of hearing things that are not real (hallucinations), being more sensitive to light, noise and touch than normal, relaxed grip on reality, numbness and tingling in your hands and feet, aching muscles, stomach problems.

• You have an allergic reaction. These signs may include: an itchy, lumpy rash (hives) or nettle rash (urticaria), swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing

Common side effects (may affect less than 1 in 10 people)

• Poor memory while taking zolpidem (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 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 side effects (may affect less than 1 in 100 people)

• Blurred eyesight or ‘seeing double’

Rare side effects (may affect less than 1 in 1,000 people)

• Being less aware of your environment
• Falling, especially in the elderly

There have been some reports of people doing things while asleep that they do not remember when waking up after taking a sleeping medicine. This includes sleep-driving, sleepwalking, preparing and eating food, and having sex. Alcohol and some medicines for depression or anxiety can increase the chance that this serious effect will happen.

Common side effects (may affect less than 1 in 10 people)

• Diarrhoea
• Feeling sick (nausea) or being sick (vomiting)
• Abdominal pain
• Respiratory infection
• Headache
• Feeling tired or agitated
• Nightmares
• Depression
• Feeling dizzy
• Feeling sleepy or drowsy
• Back pain

Uncommon side effects (may affect less than 1 in 100 people)

• Itching skin or skin rash
• Excessive sweating
• Feeling restless, aggressive, confused or irritable
• Feeling overly happy/confident (euphoric)
• Unusual skin sensations such as numbness, tingling, prickling, burning or creeping on the skin (paraesthesia)
• Tremor
• Sleepwalking (see ‘Sleep-driving and other sleep-related behaviour’)
• Lack of concentration
• Speech problems
• Blurred vision
• Changes in the amount of liver enzymes – shown up in the results of blood tests
• Changes in appetite or behaviour concerning appetite
• Muscle pain
• Muscle spasms
• Limp or weak muscles

Rare side effects (may affect less than 1 in 1,000 people)

• Itchy, lumpy rash (urticaria)
• Thinking things that are not true (delusions)
• Changes in sex drive (libido)
• You have discolouration of the skin or eyes, pain in the abdomen (stomach) or a bloated feeling, severe itching, pale or bloody stools, extreme weakness, nausea or loss of appetite. This could be caused by an infection or injury to the liver
• An illness where removal of bile from the liver is blocked (cholestasis). Signs include jaundice, rash or fever and the colour of your water (urine) becomes darker
• Changes in the way you walk

Very rare side effects (affects less than 1 in 10,000 people)

• Any changes in vision, in particular loss of vision
• Slower breathing (respiratory depression)
• Becoming dependent on zolpidem

Not known (frequency cannot be estimated from available data)

• A feeling of being out of touch with reality and being unable to think or judge clearly (psychosis)
• Feeling angry or showing unusual behaviour
• Needing to take more zolpidem in order to sleep
• Dependence and addiction (see section “How do I know if I am tolerant or addicted?”).

Drug Withdrawal

When you stop taking zolpidem you may experience drug withdrawal symptoms, which include:

• feeling anxious, shaky, irritable, agitated, confused, having panic attacks, sweating, headache, faster heartbeat or uneven heartbeat (palpitations), lower level of awareness or problems with focussing or concentrating, nightmares, seeing of hearing things that are not real (hallucinations), being more sensitive to light, noise and touch than normal, relaxed grip on reality, numbness and tingling in your hands and feet, aching muscles, stomach problems.

How do I know if I am tolerant or addicted?

If you notice any of the following signs whilst taking zolpidem, it could be a sign that you have become addicted.

• You may feel the need to keep taking the medication for longer than your doctor recommended
• You feel you need to use more than the recommended dose
• You are using the medicine for reasons other than prescribed
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

If you notice any of these signs, it is important you talk to your prescriber.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

Each 5mg tablet contains 5mg of zolpidem tartrate as the active substance.

Each 10mg tablet contains 10mg zolpidem tartrate as the active substance.

The other ingredients of Zolpidem 5mg Tablets are lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycollate, magnesium stearate, titanium dioxide (E171) and macrogol 400.

The other ingredients of Zolpidem 10mg Tablets are lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycollate, magnesium stearate, macrogol, titanium dioxide (E171), talc and polyvinyl alcohol.

Zolpidem 5mg Tablets are round, white to off-white, film-coated tablets.

Zolpidem 10mg Tablets are oval, white to off-white, film-coated tablets, with a score line and SN10 on one side.

Zolpidem 5mg Tablets are supplied in cartons of 28 tablets.

Zolpidem 10mg Tablets are supplied in cartons of 28 tablets.

Marketing Authorisation Holder

Manufacturer