Drugs List

Therapeutic Indications

Uses

Insomnia (short-term treatment)

Contraindications

Children under 18 years
Acute respiratory depression
Breastfeeding
Galactosaemia
Myasthenia gravis
Neuromuscular disorder
Pregnancy
Psychosis
Severe hepatic impairment
Severe respiratory depression
Sleep apnoea

Precautions and Warnings

Debilitation
Elderly
Females of childbearing potential
Suicidal ideation
Depression
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of alcohol abuse
History of drug misuse
History of psychiatric disorder
Lactose intolerance
Renal impairment
Respiratory impairment

May cause hepatic encephalopathy in patients with hepatic disease
Reduce dose in patients with hepatic impairment
Advise patient ability to drive or operate machinery may be impaired
Contains lactose
Monitor at regular intervals as withdrawal symptoms & dependence may occur
Monitor for rebound insomnia following withdrawal
Monitor patient for signs and symptoms of respiratory depression
Tolerance and dependence may occur
Amnesia may occur
May precipitate depression
Progressive withdrawal recommended
Discontinue if paradoxical reactions occur
Limit prescribing quantity due to suicide risk
Reduce dose in elderly
Avoid prolonged use
Lowest dose should be used to control symptoms - treatment time max 4 weeks
Only recommended for short term use
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Advise that effects are potentiated by CNS depressants (including alcohol)
Advise patient of increased risk of falls
Advise patient possible drowsiness next morning
Advise patient to ensure 8 hours of uninterrupted sleep/rest post dose
Patients should not exceed recommended dose

The cause of insomnia should be identified wherever possible, and the underlying factors treated before a hypnotic is prescribed. Failure of insomnia to remit after a 7 to 14 day course of treatment may indicate the presence of a psychiatric or physical disorder. Re-evaluate the patient at regular intervals.

Pre-existing depression may be unmasked by zolpidem. Re-evaluate the patient if insomnia persists, as insomnia may be a symptom of depression.

Physical and psychological dependence may develop, the risk of which increases with dose and duration of treatment. It is also greater in patients with a history of psychiatric disorders and/or alcohol or drug abuse. Use with extreme caution in these patients. Abrupt termination of treatment will be accompanied by withdrawal symptoms.

The patient should be advised that rebound insomnia may occur on withdrawal of treatment, and is more likely after abrupt discontinuation. Gradual decrease is therefore recommended where clinically appropriate.

Zolpidem may induce anterograde amnesia, which usually occurs several hours after administration. Patients should therefore ensure that they have 8 hours to devote to sleep before taking zolpidem.

Sleep walking and other behaviours such as 'sleep driving' and making phone calls with amnesia for the event have been reported in patients taking zolpidem. Concurrent use of alcohol and other CNS-depressants appears to increase the risk, as does exceeding the maximum recommended dose of zolpidem. Consider discontinuing if such behaviour occurs.

Pregnancy and Lactation

Pregnancy

Zolpidem is contraindicated during pregnancy.

The manufacturer does not recommend using zolpidem during pregnancy.

Animal studies indicate no increased risk of reproductive toxicity.

Extensive studies have shown no evidence of malformations during the first trimester of pregnancy. However there were reports of increased incidences of cleft lip and palate with zolpidem treatment during pregnancy. Cases of reduced foetal movement and foetal heart rate variability have been seen during the second and third trimesters of pregnancy.

Administration later in pregnancy or during labour has been associated with effects on the neonate, such as hypothermia, hypotonia, feeding difficulties and respiratory depression due to pharmacological action of the product. Severe neonatal respiratory depression has been reported. Furthermore infants born to mothers who were treated with zolpidem during the latter stages of pregnancy may have developed dependence with a risk of withdrawal symptoms postnatally. Monitoring of the newborn in the postnatal period is recommended.

Schaefer (2015) states that these drugs may be used for a short period during pregnancy. Briggs (2015) suggests there is no increased risk of congenital malformations but studies have found an increased risk for preterm birth, low birth weight and small for gestational age infants and caesarean birth.

Lactation

Zolpidem is contraindicated during breastfeeding.

The manufacturers do not recommend the use of zolpidem during breastfeeding. Zolpidem is excreted in breast milk in small amounts.

Briggs (2015) states the effects of zolpidem, if any, on a nursing infant have not been studied fully. If the mother is taking zolpidem, however, she should observe her nursing infant for increased sedation, lethargy, and changes in feeding habits.

Side Effects

Aggression
Agitation
Anger
Angioneurotic oedema
Anterograde amnesia
Asthenia
Ataxia
Back pain
Behavioural disturbances
Changes in libido
Confusion
Delusions
Dependence
Depression
Diarrhoea
Diplopia
Dizziness
Drowsiness
Falls
Fatigue
Gait abnormality
Hallucinations
Headache
Impaired consciousness
Increases in hepatic enzymes
Insomnia
Irritability
Muscle weakness
Nausea
Nightmares
Paradoxical reactions
Perceptual disturbances
Pruritus
Psychosis
Rash
Restlessness
Skin reactions
Sleep walking
Somnolence
Tolerance
Tremor
Urticaria
Vertigo
Vomiting

Presentation

Oral formulations of zolpidem.

Drugs List

Therapeutic Indications

Uses

Insomnia (short-term treatment)

Dosage

The lowest dose possible should be used to control symptoms.

Treatment duration varies from a few days to two weeks. Treatment should not exceed 4 weeks, including tapering off where clinically appropriate. Extension beyond the maximum 4 weeks should only occur if re-evaluation of the patients status has occurred.

Adults

Elderly

Patients with Hepatic Impairment

Contraindications

Children under 18 years
Acute respiratory depression
Breastfeeding
Galactosaemia
Myasthenia gravis
Neuromuscular disorder
Pregnancy
Psychosis
Severe hepatic impairment
Severe respiratory depression
Sleep apnoea

Precautions and Warnings

Debilitation
Elderly
Females of childbearing potential
Suicidal ideation
Depression
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of alcohol abuse
History of drug misuse
History of psychiatric disorder
Lactose intolerance
Renal impairment
Respiratory impairment

May cause hepatic encephalopathy in patients with hepatic disease
Reduce dose in patients with hepatic impairment
Advise patient ability to drive or operate machinery may be impaired
Contains lactose
Monitor at regular intervals as withdrawal symptoms & dependence may occur
Monitor for rebound insomnia following withdrawal
Monitor patient for signs and symptoms of respiratory depression
Tolerance and dependence may occur
Amnesia may occur
May precipitate depression
Progressive withdrawal recommended
Discontinue if paradoxical reactions occur
Limit prescribing quantity due to suicide risk
Reduce dose in elderly
Avoid prolonged use
Lowest dose should be used to control symptoms - treatment time max 4 weeks
Only recommended for short term use
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Advise that effects are potentiated by CNS depressants (including alcohol)
Advise patient of increased risk of falls
Advise patient possible drowsiness next morning
Advise patient to ensure 8 hours of uninterrupted sleep/rest post dose
Patients should not exceed recommended dose

The cause of insomnia should be identified wherever possible, and the underlying factors treated before a hypnotic is prescribed. Failure of insomnia to remit after a 7 to 14 day course of treatment may indicate the presence of a psychiatric or physical disorder. Re-evaluate the patient at regular intervals.

Pre-existing depression may be unmasked by zolpidem. Re-evaluate the patient if insomnia persists, as insomnia may be a symptom of depression.

Physical and psychological dependence may develop, the risk of which increases with dose and duration of treatment. It is also greater in patients with a history of psychiatric disorders and/or alcohol or drug abuse. Use with extreme caution in these patients. Abrupt termination of treatment will be accompanied by withdrawal symptoms.

The patient should be advised that rebound insomnia may occur on withdrawal of treatment, and is more likely after abrupt discontinuation. Gradual decrease is therefore recommended where clinically appropriate.

Zolpidem may induce anterograde amnesia, which usually occurs several hours after administration. Patients should therefore ensure that they have 8 hours to devote to sleep before taking zolpidem.

Sleep walking and other behaviours such as 'sleep driving' and making phone calls with amnesia for the event have been reported in patients taking zolpidem. Concurrent use of alcohol and other CNS-depressants appears to increase the risk, as does exceeding the maximum recommended dose of zolpidem. Consider discontinuing if such behaviour occurs.

Pregnancy and Lactation

Pregnancy

Zolpidem is contraindicated during pregnancy.

The manufacturer does not recommend using zolpidem during pregnancy.

Animal studies indicate no increased risk of reproductive toxicity.

Extensive studies have shown no evidence of malformations during the first trimester of pregnancy. However there were reports of increased incidences of cleft lip and palate with zolpidem treatment during pregnancy. Cases of reduced foetal movement and foetal heart rate variability have been seen during the second and third trimesters of pregnancy.

Administration later in pregnancy or during labour has been associated with effects on the neonate, such as hypothermia, hypotonia, feeding difficulties and respiratory depression due to pharmacological action of the product. Severe neonatal respiratory depression has been reported. Furthermore infants born to mothers who were treated with zolpidem during the latter stages of pregnancy may have developed dependence with a risk of withdrawal symptoms postnatally. Monitoring of the newborn in the postnatal period is recommended.

Schaefer (2015) states that these drugs may be used for a short period during pregnancy. Briggs (2015) suggests there is no increased risk of congenital malformations but studies have found an increased risk for preterm birth, low birth weight and small for gestational age infants and caesarean birth.

Lactation

Zolpidem is contraindicated during breastfeeding.

The manufacturers do not recommend the use of zolpidem during breastfeeding. Zolpidem is excreted in breast milk in small amounts.

Briggs (2015) states the effects of zolpidem, if any, on a nursing infant have not been studied fully. If the mother is taking zolpidem, however, she should observe her nursing infant for increased sedation, lethargy, and changes in feeding habits.

Side Effects

Aggression
Agitation
Anger
Angioneurotic oedema
Anterograde amnesia
Asthenia
Ataxia
Back pain
Behavioural disturbances
Changes in libido
Confusion
Delusions
Dependence
Depression
Diarrhoea
Diplopia
Dizziness
Drowsiness
Falls
Fatigue
Gait abnormality
Hallucinations
Headache
Impaired consciousness
Increases in hepatic enzymes
Insomnia
Irritability
Muscle weakness
Nausea
Nightmares
Paradoxical reactions
Perceptual disturbances
Pruritus
Psychosis
Rash
Restlessness
Skin reactions
Sleep walking
Somnolence
Tolerance
Tremor
Urticaria
Vertigo
Vomiting

Withdrawal Symptoms and Signs

Withdrawal symptoms may include headaches, muscle pain, extreme anxiety, tension, restlessness, confusion, irritability, rebound insomnia. In severe cases the following symptoms may occur: de realisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: March 2021

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Summary of Product Characteristics: Stilnoct 10mg tablets. Sanofi. Revised October 2019.

Summary of Product Characteristics: Zolpidem 10mg tablets. Mylan. Revised July 2019.

Summary of Product Characteristics: Zolpidem tartrate 5mg tablets. Zentiva. Revised September 2020.

Summary of Product Characteristics: Zolpidem tartrate 10mg tablets. Zentiva. Revised September 2020.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 11 March 2021

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Zolpidem Last revised: 15 February 2021
Last accessed: 11 March 2021