Ivedal Side Effects

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Answer the side-effect intent for ivedal without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Ivedal?

Ivedal contains the active ingredient Zolpidem tartrate.

• Active ingredient — Zolpidem tartrate
• Registration number — 37/2.2/0540
• Registration holder — Sanofi-aventis south africa (pty) ltd

It is approved for:

• IVEDAL contains a medicine called zolpidem tartrate and belongs to a group of medicines called hypnotics
• It works by acting on your brain to help you sleep
• IVEDAL is used to initiate sleep in adults with severe sleeping difficulties, also called insomnia, for a short term only

Common side effects of Ivedal

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• drowsiness
• dizziness
• diarrhoea
• nausea
• vomiting
• abdominal pain
• headache
• increased sleep problems
• hallucinations
• agitation
• nightmares
• memory difficulties
• tiredness
• nose, throat or lung infections (respiratory infection)
• back pain

Less frequent side effects

• confusion
• irritability
• double vision, blurred vision
• decreased concentration
• restlessness
• aggressiveness
• delusion
• rage
• abnormal behaviour
• libido disorders (changes in sex drive)
• unsteadiness, fall (mainly in older patients and when IVEDAL is not taken in accordance with the prescribing recommendations)
• muscle weakness, muscle spasms, limp or weak muscles, muscle pain, joint pain
• tolerance (loss of effectiveness of the sleep medicine)
• dependence (need to continue the sleep medicine associated with unpleasant symptoms when the sleep medicine is suddenly stopped)
• depression
• tremor
• feeling overly happy or confident (euphoric)
• unusual skin sensations such as numbness, tingling, prickling, burning or creeping on the skin (paraesthesia)
• increased sweating

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• If you are hypersensitive (allergic) to zolpidem tartrate or any of the other ingredients of IVEDAL (listed in section 6). Signs of an allergic reaction include rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue
• If you have myasthenia gravis (a condition in which the muscles become weak and tire easily)
• If you have sleep apnoea (a condition where you temporarily stop breathing while you sleep)
• If you have severe lung problems
• If you have serious liver problems
• If you are a child under 18 years of age due to an increased risk of adverse effects
• If you are pregnant, intend to become pregnant or are breastfeeding

Use with care, and tell your doctor, if

• The use of IVEDAL may lead to the development of abuse and/or physical and psychological dependence. The risk of abuse and dependence is greater in patients with a history of mental disorders and/or alcohol, illicit substance, or medicine abuse. Tell your health care provider if you have ever had a mental disorder or have abused or have been addicted to alcohol or other medicines
• Please consult with your doctor if you notice that you cannot or do not want to stop taking IVEDAL or if you feel that you need to take IVEDAL more often than prescribed to you by your doctor
• Use with caution if you have mild to moderate breathing or chest problems
• If your sleep problems persist or worsen after a short period of treatment, consult your doctor
• If your sleep problems return while you are taking IVEDAL, consult your doctor. When medicines for sleep such as IVEDAL are used for more than a few weeks, they may lose their effectiveness to help you sleep
• This is known as “tolerance”
• You may have temporary memory loss (amnesia) when taking IVEDAL. This can usually be avoided if you get a full night’s sleep (7 to 8 hours) before being active again
• Some people taking IVEDAL, may have changes in behaviour and thinking. If you or your family notice any changes in your behaviour, or if you have any unusual or disturbing thoughts, consult your doctor immediately
• If you ever had a history of sleep walking or other unusual behaviour (such as driving, eating, making a phone call or having sex) while not being fully awake after taking IVEDAL
• Use with caution if you have mild to moderate liver problems
• If you suffer from mental disorders (depression or schizophrenia) or epilepsy (fits)
• If you may be at risk of getting into a regular pattern or habit of taking IVEDAL. Children and adolescents Do not give IVEDAL to children or adolescents under 18 years of age

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding your baby, you should not take IVEDAL
• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking IVEDAL

Interactions and medicines to check

The approved leaflet names these interactions.

• Other medicines that act on the brain such as:
• medicines used in the treatment of mental conditions (antipsychotics, hypnotics, anxiolytics/sedatives, antidepressants)
• medicines used for strong pain relief (narcotic analgesics)
• medicines used for the treatment of seizures/convulsions (antiepileptic medicines)
• anaesthetics
• medicines used in the treatment of allergies (antihistamines that cause sleepiness). The combination of these medicines with IVEDAL may make you drowsier than it should and may increase the next-day psychomotor impairment effects, including impaired driving ability. In addition, you may be euphoric (increase of well-being) if narcotic analgesics (morphine and opiates) are combined with IVEDAL
• Rifampicin (antibiotic used to treat infections) as it may decrease the effect of IVEDAL on sleep
• Ketoconazole (used to treat infections) increases the effect of IVEDAL
• Fluvoxamine (an antidepressant medicine) as it may increase the effect of IVEDAL. It is not recommended to take IVEDAL with fluvoxamine
• Ciprofloxacin (antibiotic used to treat infections) as it may increase the effect of IVEDAL. It is not recommended to take IVEDAL with ciprofloxacin
• St John’s Wort (a herbal medicine used for mood swings and depression). It is not recommended to take IVEDAL with St. John’s Wort
• Opioids (medicines used for pain relief, and also contained in some cough medicines). Concomitant use of IVEDAL and opioids increases the risk of drowsiness, difficulties in breathing, coma and may be life-threatening. Because of this, the concomitant use with IVEDAL should only be considered when other treatment options are not possible. Please tell your doctor about all opioid medicines you are taking. IVEDAL with food, drink and alcohol You should not drink alcohol while taking IVEDAL

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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