Drugs List

Therapeutic Indications

Uses

Insomnia (short-term treatment)
Premedication - sedative
Transient sleep disorders

Not all indications are licensed for all age groups.

Administration

For oral administration.

To be taken before bed or prior to clinical procedures.

Contraindications

Respiratory depression
Acute pulmonary insufficiency
Phobic or obsessional states/chronic psychoses
Sleep apnoea
Severe hepatic impairment
Myasthenia gravis
Acute narrow angle glaucoma

Precautions and Warnings

Not licensed for all indications in all age groups.

Seek an underlying cause for insomnia before use of benzodiazepines.

Use with caution in patients with:
Chronic pulmonary insufficiency
Renal impairment (see Dosage - Renal Impairment )
Hepatic impairment (see Dosage - Hepatic Impairment )
Muscle weakness

Doses of 30mg and above are more likely to cause hangover effects to persist into the following day than lower doses.

A reduced dose is recommended in the elderly and debilitated and those suffering from cerebral arteriosclerosis.

The dependence potential of benzodiazepines is increased when high dosage is used, especially over long periods. Particularly in patients with a history of alcoholism, drug abuse or marked personality disorders. Tolerance may also appear after repeated use for a few weeks with short acting benzodiazepines. Treatment should not continue beyond 4 weeks, monitor regularly and avoid routine prescriptions.

Patients should not consume alcohol, or other CNS depressants as their effects may be increased, whilst taking temazepam.

Patients should be aware that abrupt withdrawal and sometimes slow withdrawal can cause rebound phenomena, whereby symptoms similar to the initial reasons for starting therapy can occur. Depression, rebound insomnia, irritability, etc have been reported. Discontinue use if psychiatric and paradoxical reactions occur (restlessness, agitation, aggressiveness, etc).

Benzodiazepines should not be used alone to treat depression or anxiety associated with depression as patients may develop suicidal ideation. May uncover depression with suicidal tendencies, discontinue if this occurs. In case of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines.

Pregnancy - (see Pregnancy section)
Breastfeeding - (see Lactation section)
If prescribed to a woman of child bearing potential, she should be warned to contact her doctor if she becomes, or intends to become pregnant.

Temazepam affects the ability to drive and operate machinery. If temazepam is used as a medication before surgical or investigative procedures, the patient should be accompanied home.

Some formulations contain sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Some formulations contain lactose, caution in galactosaemia, glucose-galactose malabsorption syndrome and lactose intolerance.
Temazepam oral solution contains 10%v/v ethanol, take into account with patients with liver disease or epilepsy or alcoholism. It may modify or increase the effect of other medicines.

Pregnancy and Lactation

Pregnancy

Benzodiazepines cross the placenta, and accumulation may occur in the neonate due to a low rate of metabolism.

Some studies suggest a risk of malformations after exposure to benzodiazepines in the first trimester, such as cardiac malformations and facial clefts. Administration during the late phase of pregnancy, or during labour at high doses, may cause 'floppy infant syndrome' (hypothermia, hypotonia, sedation, sucking problems, apnoea and cyanosis) and neonatal dependence and withdrawal (hypertonia, hyperreflexia, restlessness, sleeping disorders and tremors).

Benzodiazepines are among the drugs of first choice for the treatment of anxiety and sleeping disorders during pregnancy. They should be given at the lowest possible dose for the shortest time, long-acting benzodiazepines should be avoided. Data on the long-term effects of foetal exposure to benzodiazepines are scarce (Schaefer et al, 2007).

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Recommended for use in pregnancy? - No.

Crosses placenta? - Yes.

Effects on foetus - Possibility of malformations, 'floppy infant syndrome', neonatal withdrawal and dependence.

Lactation

Benzodiazepines are excreted in breast milk, and may result in lethargy and poor feeding. The elimination capacity for newborns develops within the first few weeks of life. The UK Drugs in Lactation Advisory Service advises that low doses (equivalent to <10mg diazepam/day) may be administered to nursing mothers, but high doses (equivalent to >10mg diazepam/day) should only be administered when the mother and infant can be monitored, as minor adverse effects have been described.

Diphenhydramine is the drug of choice for sleep disturbances during lactation, and short-acting benzodiazepines are preferred if their use is unavoidable. Single doses of benzodiazepines do not require any limitation of breastfeeding (Schaefer et al 2007). There is insufficient experience on the long-term effects on breastfed children as a result of ongoing therapy in their mothers. The CSM has recommended that benzodiazepines should not be given to breastfeeding mothers.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Drug excreted in breast milk? - Yes

Considered suitable or recommended by manufacturer? - No

Drug substance licensed in infants? - No

Side Effects

Drowsiness and light headedness (next day)
Ataxia
Amnesia
Dependence
Headache
Increased hostility and aggression (paradoxical)
Vertigo
Hypotension
Gastro-intestinal symptoms
Rash
Visual disturbances
Changes in libido
Urinary retention
Blood dyscrasias
Jaundice
Confusion
Restlessness
Agitation
Irritability
Delusions
Rages
Nightmares
Hallucinations
Psychosis
Behavioural disturbances
Depression
Suicidal tendencies
Drowsiness
Sedation
Blurred vision
Numbed emotions
Reduced alertness
Dizziness
Muscle weakness
Excitement
Unsteady gait
Fatigue
Respiratory depression
Slurred speech
Dry mouth
Restlessness (nocturnal)
Dysarthria
Tremor
Hypersalivation
Incontinence
Hypersensitivity reactions
Increases in hepatic enzymes
Skin reactions
Disinhibition

Presentation

Oral formulations of temazepam.

Drugs List

Therapeutic Indications

Uses

Insomnia (short-term treatment)
Premedication - sedative
Transient sleep disorders

Not all indications are licensed for all age groups.

Dosage

The lowest dose which can control symptoms should be used and should not be continued beyond 4 weeks. Patients who have taken benzodiazepines for a long time may require a longer period during which doses are reduced.

Treatment should always be tapered off gradually.

Adults

Elderly

Children

Patients with Renal Impairment

Patients with Hepatic Impairment

Administration

For oral administration.

To be taken before bed or prior to clinical procedures.

Contraindications

Respiratory depression
Acute pulmonary insufficiency
Phobic or obsessional states/chronic psychoses
Sleep apnoea
Severe hepatic impairment
Myasthenia gravis
Acute narrow angle glaucoma

Precautions and Warnings

Not licensed for all indications in all age groups.

Seek an underlying cause for insomnia before use of benzodiazepines.

Use with caution in patients with:
Chronic pulmonary insufficiency
Renal impairment (see Dosage - Renal Impairment )
Hepatic impairment (see Dosage - Hepatic Impairment )
Muscle weakness

Doses of 30mg and above are more likely to cause hangover effects to persist into the following day than lower doses.

A reduced dose is recommended in the elderly and debilitated and those suffering from cerebral arteriosclerosis.

The dependence potential of benzodiazepines is increased when high dosage is used, especially over long periods. Particularly in patients with a history of alcoholism, drug abuse or marked personality disorders. Tolerance may also appear after repeated use for a few weeks with short acting benzodiazepines. Treatment should not continue beyond 4 weeks, monitor regularly and avoid routine prescriptions.

Patients should not consume alcohol, or other CNS depressants as their effects may be increased, whilst taking temazepam.

Patients should be aware that abrupt withdrawal and sometimes slow withdrawal can cause rebound phenomena, whereby symptoms similar to the initial reasons for starting therapy can occur. Depression, rebound insomnia, irritability, etc have been reported. Discontinue use if psychiatric and paradoxical reactions occur (restlessness, agitation, aggressiveness, etc).

Benzodiazepines should not be used alone to treat depression or anxiety associated with depression as patients may develop suicidal ideation. May uncover depression with suicidal tendencies, discontinue if this occurs. In case of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines.

Pregnancy - (see Pregnancy section)
Breastfeeding - (see Lactation section)
If prescribed to a woman of child bearing potential, she should be warned to contact her doctor if she becomes, or intends to become pregnant.

Temazepam affects the ability to drive and operate machinery. If temazepam is used as a medication before surgical or investigative procedures, the patient should be accompanied home.

Some formulations contain sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Some formulations contain lactose, caution in galactosaemia, glucose-galactose malabsorption syndrome and lactose intolerance.
Temazepam oral solution contains 10%v/v ethanol, take into account with patients with liver disease or epilepsy or alcoholism. It may modify or increase the effect of other medicines.

Pregnancy and Lactation

Pregnancy

Benzodiazepines cross the placenta, and accumulation may occur in the neonate due to a low rate of metabolism.

Some studies suggest a risk of malformations after exposure to benzodiazepines in the first trimester, such as cardiac malformations and facial clefts. Administration during the late phase of pregnancy, or during labour at high doses, may cause 'floppy infant syndrome' (hypothermia, hypotonia, sedation, sucking problems, apnoea and cyanosis) and neonatal dependence and withdrawal (hypertonia, hyperreflexia, restlessness, sleeping disorders and tremors).

Benzodiazepines are among the drugs of first choice for the treatment of anxiety and sleeping disorders during pregnancy. They should be given at the lowest possible dose for the shortest time, long-acting benzodiazepines should be avoided. Data on the long-term effects of foetal exposure to benzodiazepines are scarce (Schaefer et al, 2007).

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Recommended for use in pregnancy? - No.

Crosses placenta? - Yes.

Effects on foetus - Possibility of malformations, 'floppy infant syndrome', neonatal withdrawal and dependence.

Lactation

Benzodiazepines are excreted in breast milk, and may result in lethargy and poor feeding. The elimination capacity for newborns develops within the first few weeks of life. The UK Drugs in Lactation Advisory Service advises that low doses (equivalent to <10mg diazepam/day) may be administered to nursing mothers, but high doses (equivalent to >10mg diazepam/day) should only be administered when the mother and infant can be monitored, as minor adverse effects have been described.

Diphenhydramine is the drug of choice for sleep disturbances during lactation, and short-acting benzodiazepines are preferred if their use is unavoidable. Single doses of benzodiazepines do not require any limitation of breastfeeding (Schaefer et al 2007). There is insufficient experience on the long-term effects on breastfed children as a result of ongoing therapy in their mothers. The CSM has recommended that benzodiazepines should not be given to breastfeeding mothers.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Drug excreted in breast milk? - Yes

Considered suitable or recommended by manufacturer? - No

Drug substance licensed in infants? - No

Effects on Ability to Drive and Operate Machinery

This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988 (England and Wales). This medicine may be subject to police testing and has specified maximum blood levels for driving. When prescribing this medicine: Advise patient the medicine can affect cognitive function and is likely to affect ability to drive. Advise patient not to drive until they know how the medicine affects them. It is an offence to drive while under the influence of this medicine. However, a patient is not committing an offence (called 'statutory defence') if: 1.The medicine has been prescribed to treat a medical or dental problem and 2.The medicine has been taken according to the instructions given by the prescriber and/or in the information provided with the medicine and 3.The medicine was not affecting the ability to drive safely. For further guidance see https://www.gov.uk

Counselling

Advise patients that their ability to drive and operate machinery may be affected.

Women of child bearing potential should be warned to contact her doctor if she becomes, or intends to become pregnant.

Advise patient to avoid alcohol during treatment.

Side Effects

Drowsiness and light headedness (next day)
Ataxia
Amnesia
Dependence
Headache
Increased hostility and aggression (paradoxical)
Vertigo
Hypotension
Gastro-intestinal symptoms
Rash
Visual disturbances
Changes in libido
Urinary retention
Blood dyscrasias
Jaundice
Confusion
Restlessness
Agitation
Irritability
Delusions
Rages
Nightmares
Hallucinations
Psychosis
Behavioural disturbances
Depression
Suicidal tendencies
Drowsiness
Sedation
Blurred vision
Numbed emotions
Reduced alertness
Dizziness
Muscle weakness
Excitement
Unsteady gait
Fatigue
Respiratory depression
Slurred speech
Dry mouth
Restlessness (nocturnal)
Dysarthria
Tremor
Hypersalivation
Incontinence
Hypersensitivity reactions
Increases in hepatic enzymes
Skin reactions
Disinhibition

Withdrawal Symptoms and Signs

If treatment is withdrawn abruptly there are a number of symptoms which can occur which can appear to be the same as the the symptoms which were the cause for initiation of treatment. Symptoms such as:

Depression
Nervousness
Rebound Insomnia
Irritability
Sweating
Headaches
Dizziness
Impaired concentration
Tinnitus
Loss of appetite
Tremor
Perceptual disturbances
Nausea
Vomiting
Abdominal cramps
Palpitations
Mild systolic hypertension
Tachycardia
Orthostatic hypotension
Photophobia
Hyperacusis
Muscle pain
Extreme anxiety
Tension
Restlessness
Confusion
Diarrhoea

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 ).

Shelf Life and Storage

Store between 4 and 25 degrees C.
Protect from light.

Further Information

Last Full Review Date: March 2011

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 8th edition (2008) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of Product Characteristics: Temazepam Tablets 20mg. Actavis UK Ltd. Revised January 2017.

Summary of Product Characteristics: Temazepam Tablets 20mg. Actavis UK Ltd. Revised January 2017.

Summary of Product Characteristics: Temazepam 10mg/5ml Oral Solution. Rosemont Ltd. Revised June 2016.

Summary of Product Characteristics: Temazepam Tablets 10mg. Sandoz Ltd. Revised February 2016.

Summary of Product Characteristics: Temazepam Tablets 20mg. Sandoz Ltd. Revised February 2016.

Drugs and Lactation Database
Available at: https://toxnet.nlm.nih.gov/
Last accessed October 12, 2010

Clinical Knowledge Summaries - Insomnia - Management
Available at: https://www.cks.nhs.uk/insomnia
Last accessed October 12, 2010

Committee on Safety of Medicines/Medicines Control Agency. Current problems in Pharmacovigilance (1997); 23: 10
Available at: https://www.mhra.gov.uk/Publications/CON007479
Reminder: avoid benzodiazepines in pregnancy and lactation .
Last accessed October 12, 2010

UK Drugs in Lactation Advisory Service.
Available at: https://www.ukmicentral.nhs.uk/drugpreg/qrg_p1.asp
Last accessed October 12, 2010

Gov.uk. Government departments. Department for Transport. Publications. Drug driving and medicine: advice for healthcare professionals. Drug driving: Guidance for healthcare professionals on drug driving. Available at: https://www.gov.uk Last accessed: 6 January 2015

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 August 2017