Sleeping medicines Side Effects: Sleep and Fatigue

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

What is sleeping medicines?

Sleeping medicines covers several products registered in South Africa, not one. They work in a similar way, and their approved leaflets do not list identical side effects.

The medicines covered here, and the leaflet used for each:

• zolpidem — ZOLTAB 5 & 10, Alkem Laboratories (Pty) Ltd (Tablet)
• zopiclone — BIO ZOPICLONE, Biotech Laboratories (Pty) Ltd (Film-coated tablets))
• doxylamine — SYNDOL, Adcock Ingram Limited (Tablets)
• melatonin — Cadiatev, Teva Pharmaceuticals (Pty) Ltd (Prolonged-release tablets.)

Common side effects of sleeping medicines

Each medicine in this group has its own approved leaflet, and the effects below are the ones that leaflet lists. They are shown separately rather than combined, because the leaflets do not agree on what to list or how to word it.

Zolpidem (ZOLTAB 5 & 10)

• Poor memory while taking ZOLTAB (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 ZOLTAB 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)
• Diarrhoea
• Feeling sick (nausea) or being sick (vomiting)
• Abdominal pain
• Respiratory infection
• Headache
• Feeling tired or agitated
• Nightmares
• Depression

The leaflet lists 29 more. Read the full leaflet.

Zopiclone (BIO ZOPICLONE)

• a bitter or metallic taste in your mouth or a dry mouth
• feeling drowsy or sleepy
• nightmares
• agitation
• aggressiveness
• confusion
• headache
• dizziness
• nausea and vomiting, diarrhoea
• skin rash, hives
• increased liver enzymes as shown in laboratory tests
• chills, sweating, tiredness Side effects with unknown frequency:

The leaflet lists 15 more. Read the full leaflet.

Doxylamine (SYNDOL)

• insomnia, deep sleep, drowsiness
• incoordination
• dry mouth
• nervousness
• tremors, convulsions
• facial flushing
• Abdominal pain including risk of inflammation of pancreas, which causes severe pain in the abdomen and back
• Restlessness
• sores in the mouth
• Decreased libido
• Lack of energy
• Sensitivity to light

The leaflet lists 11 more. Read the full leaflet.

Melatonin (Cadiatev)

• a reactivation of the chickenpox virus in the body, causing a painful rash
• reduced number of white blood cells in the blood
• reduced blood platelets, which increases risk of bleeding or bruising
• a high level of a certain type of fat (triglycerides) in the blood
• low serum calcium levels in the blood, low sodium levels in the blood
• irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety, migraine, headache
• altered mood, aggression, agitation, crying, stress symptoms, early morning awakening, increased sex drive, depressed mood, depression
• restlessness associated with increased activity, dizziness, tiredness, disturbance in attention, memory impairment
• lethargy (tiredness, lack of energy), restless legs syndrome, poor quality sleep, ‘pins and needles’ feeling, migraine, fainting
• feeling of drowsiness
• visual impairment, excessive tearing
• blurred vision

The leaflet lists 19 more. Read the full leaflet.

Serious side effects and warning signs

None of the leaflets reviewed set out a separate serious-effects list.

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

Cautions from each medicine’s approved leaflet.

Zolpidem (ZOLTAB 5 & 10)

Do not use it at all if:

• you are allergic (hypersensitive) to zolpidem tartrate or any of the other ingredients of this medicine (listed in section 6)
• you have 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

Use with care, and tell your doctor, if:

• you have a history of alcohol or drug abuse
• 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. Use of ZOLTAB may lead to the development of abuse and/or physical and psychological dependence. The risk of dependence is greater when ZOLTAB is used for longer than 4 weeks, and in patients with a history of mental disorders and/or alcohol, illicit substances, or drug abuse. Tell your healthcare provider if you have ever had a mental disorder or have abused or have been dependent on alcohol, illicit substances, or medicines. ZOLTAB 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 ZOLTAB. Next day psychomotor impairment The day after taking ZOLTAB, 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

Zopiclone (BIO ZOPICLONE)

Do not use it at all if:

• If you are hypersensitive (allergic) to zopiclone or any of the other ingredients of BIO ZOPICLONE 7,5 (listed in section 6)
• If your lungs do not work properly (respiratory failure)
• If your liver function is severely impaired
• If you are suffering from sleep apnoea (temporary stopping of breathing during sleep)
• If you have ever experienced sleepwalking or other unusual behaviour (while not being fully awake after taking BIO ZOPICLONE 7,5)
• If you have emphysema, asthma, bronchitis or other lung disease

Use with care, and tell your doctor, if:

• If you have recently taken BIO ZOPICLONE 7,5 or other similar medicines for more than four weeks
• If you have any liver problems
• If you have any kidney problems, your doctor may need to give you a lower dose of BIO ZOPICLONE 7,5
• If you have a history of alcohol or drug abuse
• If you are suffering from depression or anxiety
• If you are elderly, your doctor may need to give you a lower dose of BIO ZOPICLONE 7,5

Doxylamine (SYNDOL)

Do not use it at all if:

• if you are hypersensitive (allergic) to codeine phosphate, doxylamine succinate, paracetamol, caffeine or any of the other ingredients of SYNDOL Tablets (listed in section 6)
• If you taking monoamine oxidase inhibitors or within 14 days of stopping such treatment
• if you are taking other medicines containing codeine or any other paracetamol-containing medicines
• If you suffer from shortness of breath, accompanied by a bluish discoloration of the skin especially and excessive mucous from the chest
• After operations on the bile duct
• if you suffer from alcoholism

Use with care, and tell your doctor, if:

• as this product contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately
• Do not use continuously for more than 10 days without consulting your doctor
• Consult your doctor if no relief is obtained with the recommended dosage
• Exceeding the prescribed dose, together with prolonged and continuous use of this medication, may lead to dependency and addiction
• This medicine may lead to drowsiness and impaired concentration that may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants
• if you have high blood pressure or any heart problems

Melatonin (Cadiatev)

Do not use it at all if:

• if you are hypersensitive (allergic) to melatonin or to any other ingredients of CADIATEV (listed in section 6)
• if you are pregnant or breastfeeding

Use with care, and tell your doctor, if:

• if you suffer from liver or kidney problems. No studies on the use of CADIATEV in people with liver or kidney diseases have been performed, you should speak to your doctor before taking CADIATEV as its use is not recommended
• if you have been told you suffer from an autoimmune disease (where the body is ‘attacked’ by its own immune system). No studies on the use of CADIATEV in people with auto-immune diseases have been performed; therefore, you should speak to your doctor before taking CADIATEV as its use is not recommended
• smoking may make CADIATEV less effective, because the components of tobacco smoke can increase the breakdown of melatonin by the liver. Children and adolescents: Do not give this medicine to children below 18 years as it has not been tested and its effects are unknown

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.

Related pages

• Lexamil side effects

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