Zolpidem Side Effects

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

Part of mental health medication side effects side effects.

What is zolpidem?

Zolpidem contains the active ingredient Zolpidem tartrate.

• Active ingredient — Zolpidem tartrate
• Registration number — 57/2.2/0188
• Registration holder — Adcock Ingram Limited

It is approved for:

• ZOLPIDEM XR 12,5 ADCO 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
• ZOLPIDEM XR 12,5 ADCO is used to initiate sleep in adults below the age of 65 years with sleeping difficulties, also called insomnia, for a short-term only

Common side effects of zolpidem

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

• Influenza (cough, congestion, runny nose)
• anxiety, slowed speech, disorientation
• headache, dizziness, drowsiness, memory problems, attention problems, drugged feeling, dry mouth, light headedness, feeling overly happy/confident (euphoric), feeling sluggish
• visual disturbances, double vision, eye redness
• sinusitis
• nausea (feeling sick), constipation, diarrhoea, stomach ache, indigestion, hiccups
• muscle pain/cramps, neck pain, back pain
• bladder or kidney infection
• tiredness

Less frequent side effects

• Lower and upper respiratory tract infections, ear infection with discharge from the ear (inner, middle and outer), shingles (a viral infection) (herpes simplex), abscess
• anaemia, abnormal blood test results, low white blood cell count, thrombosis (blood clot)
• intestinal infection marked by diarrhoea and cramps, middle ear infection, outer ear infection, abscess, shingles
• appetite disorder, high blood glucose levels, thirst, gout, high cholesterol, puffy eyes, abnormal blood test results, higher appetite weight loss
• depression, confusion, lack of interest, mood swings, binge eating, nightmares, feeling very happy, stress symptoms, a sensation of impending threat, feelings of suffocation, and sensations of floating, spinning or falling when falling asleep
• hallucination (seeing and hearing things that are not real)
• an extreme, unrealistic feeling of physical and emotional well-being
• depersonalisation (a state in which one’s thoughts and feelings seem unreal or not to belong to oneself)
• unsteadiness/tendency to fall, numbness, pins and needles, a lack of muscle control or coordination of voluntary movements, such as walking or picking up objects, burning sensation, dizziness when standing up, altered taste, muscle spasm, tremor, agitation, trouble remembering, learning new things, concentrating, or making decisions that affect their everyday life, feeling detached, slurred speech, exaggerated mood swings (uncontrollable laughing or crying, or heightened irritability or temper), poor concentration, nervousness, abnormal thinking, memory loss/forgetfulness, illusion, leg cramps, migraine, sleeping (after daytime dosing), yawning, increased sweating, unhealthy pale appearance
• speech disorder, a state of near-unconsciousness or insensibility, unable to walk in the usual way, aggressive reaction, lack of interest, enthusiasm, or concern, lower sex drive, a belief of altered reality, memory loss, feeling that you’re observing yourself from outside your body, a stabbing, burning, and often severe pain due to an irritated or damaged nerve, inflammation of a nerve, damage to the nerves, poor ability to adapt to your environment, panic attacks, weakened muscle movements, personality disorder, sleepwalking, involuntary muscle contractions, fainting, hot flushes, cramping rectal pain with a feeling that bowel needs to be emptied even if you already had complete bowel movement, increased or altered saliva, weakness, loss of movement, impotence (sexual dysfunction)
• foul, salty or metallic taste in your mouth
• red eyes, blurred vision, altered visual depth perception, tired eyes, eye irritation, eye pain, eye inflammation, conjunctivitis (pink eye), abnormal secretion of tears, seeing flashes of light, increased pressure in the eye, a problem with focusing, an open sore in the eye
• vertigo (sensation of spinning or swaying), ringing or buzzing noise in both ears
• rapid heartbeats, low blood pressure (including when getting up from a lying down), position conditions that affect blood flow and the blood vessels in the brain, high blood pressure and worsening of high blood pressure, artery or vein inflammation, varicose veins
• cough, dry irritated throat, bronchitis (inflammation of the lining of bronchial tubes), laryngitis (throat infection), pneumonia (lung infection), difficulty or shallow breathing, nose bleeds
• vomiting (being sick), stomach pain, excessive gas in your stomach, frequent bowel movements,a burning sensation in your chest (heartburn) usually after eating which might be worse at night, inflammation of the small intestine, burping, inflammation of the stomach, haemorrhoids, obstruction in the intestines, bleeding from your rectum, tooth cavities
• blood disorders, including low blood cell count, abnormal lymph node size, unusual large red blood cells, purple-coloured spots and patches that occur on the skin, and in mucus membranes, including the lining of the mouth, porphyria (a rare hereditary blood disease)
• wrinkling of your skin, skin rashes, hives, contact eczema, acne, light sensitivity, skin wrinkles, itching skin, forming of blisters, boils
• pain in a joint, arthritis (joint inflammation), sciatica (compressed nerve in the lower back causing back, leg and hip pain), osteoarthritis, tendon inflammation
• painful or difficult urination, bladder infection, passing more or less urine than is normal for you, inability to pass urine, frequent urination at night, kidney infection, kidney pain
• heavy menstrual flow, itchy and sore in and around your vagina (women), breast pain, painful menstruation, breast tumour
• abnormal physical weakness or lack of energy, feeling of tiredness, drowsiness, pain, fever, chest discomfort, feeling drunk, influenza-like illness, swelling, falling, general discomfort, trauma, swelling in the face, hot flashes, restless legs, higher tolerance to medicines
• higher body temperature, higher heart rate, abnormal blood test results

Frequency unknown side effects

• Sleep walking, restlessness, aggression, delusion, anger, abnormal behaviour, dependence/addiction
• liver injury
• muscle weakness

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 ZOLPIDEM XR 12,5 ADCO (listed in section 6)
• if you are a child under 18 years of age
• if you have sleep apnoea (a condition where you temporarily stop breathing while you sleep)
• if you have myasthenia gravis (a condition in which the muscles become weak and tire easily)
• if you have serious liver problems
• if you have severe lung problems
• if you are pregnant or are breastfeeding

Use with care, and tell your doctor, if

• Use with caution if you have mild to moderate breathing or chest problems
• You may have temporary memory loss (amnesia) when taking ZOLPIDEM XR 12,5 ADCO. This can usually be avoided if you get a full night’s of sleep (7 to 8 hours) before being active again
• Symptoms like restlessness, irritability, agitation, aggression, delusion, anger, nightmares, hallucinations, abnormal behaviour are known to occur when taking ZOLPIDEM XR 12,5 ADCO. Should these occur stop taking ZOLPIDEM XR 12,5 ADCO and consult your health care provider immediately
• If you have a history or are experiencing the following symptoms while taking ZOLPIDEM XR 12,5 ADCO: sleep walking, sleep driving, preparing and eating food, making phone calls or having sex, with no memory of these events. Consult your health care provider immediately if you experience any of the above symptoms
• If your sleep problems return while you are taking ZOLPIDEM XR 12,5 ADCO, consult your doctor. When medicines for sleep such as ZOLPIDEM XR 12,5 ADCO are used for more than a few weeks, they may lose their effectiveness to help you sleep
• This is known as tolerance
• The use of ZOLPIDEM XR 12,5 ADCO may lead to the development of abuse and/or physical and mental dependence. The risk of abuse and dependence is greater in patients with a history of mental disorders and/or alcohol, illegal 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
• If your sleep problems persist or worsen after a short period of treatment, consult your doctor
• If you have mild to moderate liver problems
• Some people taking ZOLPIDEM XR 12,5 ADCO 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 have heart problems. Children and adolescents Do not give ZOLPIDEM XR 12,5 ADCO to children or adolescents under 18 years of age

Pregnancy and breastfeeding

• 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 ZOLPIDEM XR 12,5 ADCO
• Do not take ZOLPIDEM XR 12,5 ADCO during pregnancy and breastfeeding

Interactions and medicines to check

The approved leaflet names these interactions.

• Other medicines that work 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, opioids), − medicines used for the treatment of seizures/fits (antiepileptic medicines), − anaesthetics, − medicines used in the treatment of allergies (antihistamines that cause sleepiness). The combination of these medicines with ZOLPIDEM XR 12,5 ADCO 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 ZOLPIDEM XR 12,5 ADCO
• Medicine used to treat fungal infections (ketoconazole) increases the effect of ZOLPIDEM XR 12,5 ADCO
• The following medicines may increase the effect of ZOLPIDEM XR 12,5 ADCO and it is not recommended to take them together: − medicine used to treat depression (fluvoxamine) − medicine used to treat bacterial infections (ciprofloxacin)
• The following medicines may decrease the effect of ZOLPIDEM XR 12,5 ADCO and it is not recommended to take them together: − medicine used to treat tuberculosis (TB) (rifampicin) − herbal medicine used for mood swings and depression (St John’s Wort). ZOLPIDEM XR 12,5 ADCO with food, drink, and alcohol ZOLPIDEM XR 12,5 ADCO should not be administered with or immediately after a meal, for faster onset of sleep. ZOLPIDEM XR 12,5 ADCO should not be taken with alcohol

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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