Drugs List

Therapeutic Indications

Uses

Insomnia (short-term treatment)

Contraindications

Children under 18 years
Galactosaemia
Myasthenia gravis
Neuromuscular disorder
Respiratory depression
Severe hepatic impairment
Severe respiratory impairment
Sleep apnoea

Precautions and Warnings

Debilitation
Elderly
Predisposition to seizures
Suicidal ideation
Acute narrow angle glaucoma
Breastfeeding
Depression
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of alcohol abuse
History of drug misuse
Lactose intolerance
Personality disorder
Pregnancy
Psychiatric disorder
Renal impairment

Withdrawal may induce seizures, especially in those predisposed to seizure
Advise ability to drive/operate machinery may be affected by side effects
Advise patient not to drive until they know how the medicine affects them
Advise patient this medicine may be subject to driving restrictions
Not suitable as sole treatment of depression or anxiety with depression
Contains lactose
Monitor for rebound insomnia following withdrawal
Monitor patients with a history of alcoholism and drug abuse
Monitor patients with marked personality disorders
Neonate exposed in utero: Monitor for neonatal withdrawal syndrome
Prolonged or excessive use may result in dependence
Amnesia may occur
May cause paradoxical behaviour
Potential for withdrawal symptoms
Tolerance may develop with continued use
Do not withdraw this drug suddenly
Withdraw gradually after long-term use
Discontinue if paradoxical reactions occur
Limit prescribing quantity due to suicide risk
Maintain treatment at the lowest effective dose
Avoid long term continuous therapy
Not recommended for use longer than 4 weeks
Only recommended for short term use
Advise patient to avoid alcohol during treatment

Pregnancy and Lactation

Pregnancy

Use lormetazepam with caution during pregnancy.

A manufacturer suggests benzodiazepines should not be used during pregnancy especially during the first and last trimesters.

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). Neonatal dependence and withdrawal may also occur in infants of mothers who took benzodiazepines chronically during the latter stages of pregnancy. Data on the long-term effects of foetal exposure to benzodiazepines are scarce.

Schaefer suggests 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, and long-acting benzodiazepines should be avoided. Observe the neonate for respiratory depression, withdrawal symptoms or adaptation problems, particularly when benzodiazepines have been used up to delivery.

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 to 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 ).

Lactation

Use lormetazepam with caution whilst breastfeeding.

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.

Schaefer suggests 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. 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 they 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

Side Effects

Agitation
Allergic dermatitis
Altered liver function tests
Amnesia
Anaphylactoid reaction
Anaphylaxis
Anterograde amnesia
Apnoea
Asthenia
Ataxia
Behavioural disturbances
Blood disorders
Changes in libido
Coma
Confusion
Constipation
Delusions
Dependence
Depression
Disinhibition
Disturbances of appetite
Dizziness
Drowsiness and light-headedness (next day)
Dysarthria
Euphoria
Excitement
Extrapyramidal effects
Fatigue
Gastro-intestinal symptoms
Hallucinations
Headache
Hypersensitivity reactions
Hyponatraemia
Hypotension
Hypothermia
Impaired memory
Impotence
Inappropriate secretion of antidiuretic hormone
Increased hostility and aggression (paradoxical)
Insomnia
Irritability
Jaundice
Muscle weakness
Nausea
Nightmares
Numbed emotions
Paradoxical reactions
Pre-existing depression may be unmasked
Psychosis
Rages
Rash
Reduced alertness
Respiratory depression
Restlessness
Salivation changes
Sedation
Sexual disturbances
Sleep disturbances
Slurred speech
Suicidal tendencies
Tremor
Urinary retention
Vertigo
Visual disturbances

Presentation

Tablets containing lormetazepam

Drugs List

Therapeutic Indications

Uses

Insomnia (short-term treatment)

Dosage

An underlying cause for insomnia should be sought before deciding upon the use of benzodiazepines for symptomatic relief.

If possible, treatment should be intermittent.
The dosage should be determined on an individual basis, taking into account the severity of insomnia, and the patient's response to the treatment.
The lowest dose which can control the symptoms should be used for the shortest time possible, and the maximum dose should not be exceeded.

Adults

Elderly

Additional Dosage Information

Contraindications

Children under 18 years
Galactosaemia
Myasthenia gravis
Neuromuscular disorder
Respiratory depression
Severe hepatic impairment
Severe respiratory impairment
Sleep apnoea

Precautions and Warnings

Debilitation
Elderly
Predisposition to seizures
Suicidal ideation
Acute narrow angle glaucoma
Breastfeeding
Depression
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of alcohol abuse
History of drug misuse
Lactose intolerance
Personality disorder
Pregnancy
Psychiatric disorder
Renal impairment

Withdrawal may induce seizures, especially in those predisposed to seizure
Advise ability to drive/operate machinery may be affected by side effects
Advise patient not to drive until they know how the medicine affects them
Advise patient this medicine may be subject to driving restrictions
Not suitable as sole treatment of depression or anxiety with depression
Contains lactose
Monitor for rebound insomnia following withdrawal
Monitor patients with a history of alcoholism and drug abuse
Monitor patients with marked personality disorders
Neonate exposed in utero: Monitor for neonatal withdrawal syndrome
Prolonged or excessive use may result in dependence
Amnesia may occur
May cause paradoxical behaviour
Potential for withdrawal symptoms
Tolerance may develop with continued use
Do not withdraw this drug suddenly
Withdraw gradually after long-term use
Discontinue if paradoxical reactions occur
Limit prescribing quantity due to suicide risk
Maintain treatment at the lowest effective dose
Avoid long term continuous therapy
Not recommended for use longer than 4 weeks
Only recommended for short term use
Advise patient to avoid alcohol during treatment

Pregnancy and Lactation

Pregnancy

Use lormetazepam with caution during pregnancy.

A manufacturer suggests benzodiazepines should not be used during pregnancy especially during the first and last trimesters.

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). Neonatal dependence and withdrawal may also occur in infants of mothers who took benzodiazepines chronically during the latter stages of pregnancy. Data on the long-term effects of foetal exposure to benzodiazepines are scarce.

Schaefer suggests 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, and long-acting benzodiazepines should be avoided. Observe the neonate for respiratory depression, withdrawal symptoms or adaptation problems, particularly when benzodiazepines have been used up to delivery.

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 to 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 ).

Lactation

Use lormetazepam with caution whilst breastfeeding.

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.

Schaefer suggests 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. 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 they 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

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). 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.

Counselling

Advise patients that the treatment will be of limited duration, and that it will be discontinued gradually.

Advise patients that impairment may be intensified by alcohol and that they should not drink alcohol during treatment with lormetazepam.

Advise patients of the possibility rebound insomnia.

Advise women of childbearing potential to contact their physician if they intend to become, or suspect they may be pregnant.

Advise patients not to drive or operate machinery if affected by sedation, amnesia, impaired concentration or impaired muscle function. Insufficient sleep may increase the likelihood of impaired alertness.

Side Effects

Agitation
Allergic dermatitis
Altered liver function tests
Amnesia
Anaphylactoid reaction
Anaphylaxis
Anterograde amnesia
Apnoea
Asthenia
Ataxia
Behavioural disturbances
Blood disorders
Changes in libido
Coma
Confusion
Constipation
Delusions
Dependence
Depression
Disinhibition
Disturbances of appetite
Dizziness
Drowsiness and light-headedness (next day)
Dysarthria
Euphoria
Excitement
Extrapyramidal effects
Fatigue
Gastro-intestinal symptoms
Hallucinations
Headache
Hypersensitivity reactions
Hyponatraemia
Hypotension
Hypothermia
Impaired memory
Impotence
Inappropriate secretion of antidiuretic hormone
Increased hostility and aggression (paradoxical)
Insomnia
Irritability
Jaundice
Muscle weakness
Nausea
Nightmares
Numbed emotions
Paradoxical reactions
Pre-existing depression may be unmasked
Psychosis
Rages
Rash
Reduced alertness
Respiratory depression
Restlessness
Salivation changes
Sedation
Sexual disturbances
Sleep disturbances
Slurred speech
Suicidal tendencies
Tremor
Urinary retention
Vertigo
Visual disturbances

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: May 2013

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.

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press https://www.medicinescomplete.com Accessed on June 20, 2014.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Dormagen tablets. Genus Pharmaceuticals Ltd. Revised July 2010.

Clinical Knowledge Summaries - Insomnia - Management
Insomnia
Available at: https://cks.nice.org.uk/insomnia#!scenariorecommendation
Last accessed: June 20, 2014

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: June 20, 2014.

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 New drug driving offence implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: https://www.mhra.gov.uk Last accessed: 6 January 2015