Stilnox Side Effects

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

What is Stilnox?

Stilnox contains the active ingredient Zolpidem tartrate.

• Active ingredient — Zolpidem tartrate
• Registration number — 54/2.2/0324
• Registration holder — Ranbaxy Pharmaceuticals (Pty) Ltd

It is approved for:

• ZILSUN MR contains a medicine called zolpidem tartrate
• This belongs to a group of medicines called hypnotics
• It works by acting on your brain to help you sleep
• ZILSUN MR is used to initiate sleep in adults below the age of 65 years with sleeping difficulties, also called insomnia, for a short-term use only

Common side effects of Stilnox

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

• Flu with symptoms, such as high temperature, sore throat, runny nose, cough and chills
• Anxiety, slowing of speech, thinking and body movements, disorientation, headache, excessive sleepiness, dizziness, memory difficulties, disturbance in attention
• Visual disturbance
• Feeling sick, constipation
• Muscle pain, muscle cramp, neck pain, back pain, tiredness

Less frequent side effects

• Stomach and intestinal infections
• Infections of the inner ear and outer ear
• Lung infections
• Infections of the mouth, nose, sinus, throat and voice box (often referred to as “colds”)
• Depression, seeing or hearing things that are not real, lack of interest, confusion, experience of feeling unreal and detached, depressed mood, loss of inhibition, feeling overly happy/confident, frequent mood changes, nightmares, feeling stressed, feeling of unsteadiness or dizziness when standing or walking
• Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin
• Unsteadiness when walking, burning sensation, dizziness with change in posture, tremor
• Taste disturbances
• Muscle cramp
• Eye redness, blurred vision, other vision problems like difficulty in assessing depth, eye strain
• A feeling of dizziness or “spinning”, ringing in the ears
• Cough, dryness in throat, throat irritation
• Being sick, abdominal discomfort, excessive gas in the stomach or bowel, passing stools frequently, heartburn (acidity problem)
• Skin allergy, wrinkling of skin
• Joint pain
• Pain when passing urine, pain during periods, heavy menstrual periods, dryness of vulva and vagina
• Unusual weakness, feeling drunk, flu-like illness, lack of energy, pain, fever, high blood pressure, increased heart rate
• Symptoms related to nervous system have been reported frequently in elderly patients. If any of the side effects become serious, or

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 ZILSUN MR (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
• if you are pregnant, intend to become pregnant or are breastfeeding your baby (see

Use with care, and tell your doctor, if

• If sleep problems persist or worsen after a short period of treatment (e.g 7-14 days of treatment), consult your doctor
• If you have mild to moderate breathing or chest problems
• If you are taking medicines called opioids (medicines used to treat moderate to severe pain, such as morphine and codeine) as it may cause sedation, breathing difficulties, coma, and death
• You may have temporary memory loss (anterograde amnesia) when taking ZILSUN MR. This can usually be avoided if you get a full night sleep (7 to 8 hours) before being active again
• Some people taking ZILSUN MR 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 may be at risk of getting into a regular pattern or habit of taking ZILSUN MR (dependence)
• If sleep problems return while you are taking ZILSUN MR consult your doctor. When medications for sleep such as ZILSUN MR are used for more than a few weeks, they may lose their effectiveness to help you sleep
• This is known as ‘tolerance”
• If you have mild to moderate liver problems
• If you suffer from depression (feeling sad) or mental illness Sleep-walking and other sleep-related behaviour: 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, taking more dose than prescribed and some medicines for depression or anxiety can increase the chance that this serious effect will happen. Dependence and abuse: The use of ZILSUN MR may lead to you becoming dependent on taking ZILSUN MR. Please consult with your doctor if you notice that you cannot or do not want to stop taking ZILSUN MR or if you feel that you need to take ZILSUN MR more often than prescribed to you by your doctor

Pregnancy and breastfeeding

• ZILSUN MR is not recommended for use in an adult over the age of 65 years

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) such as risperidone, quetiapine (Seroquel), olanzapine, diazepam and fluoxetine
• medicines used for strong pain relief (narcotic analgesics) such as morphine and codeine
• medicines used for the treatment of fits/convulsions (antiepileptic medicines) such as carbamazepine and lamotrigine
• medicines used during tests and surgical operations to numb sensation in certain areas of the body or induce sleep; this prevents pain and discomfort (anaesthetics)
• medicines used in the treatment of allergies (sedative antihistamines) such Chlorphenamine and clemastine. The combination of these medicines with ZILSUN MR may make you more drowsy than you should. In addition, you may be euphoric (increase of wellbeing) if narcotic analgesics (morphine and opiates) are combined with ZILSUN MR
• Medicines that decrease the normal elimination of zolpidem by the liver (Fluvoxamine and Ciprofloxacin)
• Ketoconazole (used to treat fungal infections) increases the effect of ZILSUN MR
• Rifampicin (used for treating bacterial infections), as it may decrease the effect of ZILSUN MR on sleep. ZILSUN MR with food, drink and alcohol ZILSUN MR should not be taken with or immediately after a meal. Do not drink alcohol while you are taking ZILSUN MR. Pregnancy, breastfeeding and fertility 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 this medicine. If you are pregnant or breastfeeding your baby, do not take ZILSUN MR

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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