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Lormetazepam oral

Updated 2 Feb 2023 | Hypnotics


Tablets containing lormetazepam

Drugs List

  • DORMAGEN 1mg tablets
  • DORMAGEN 500microgram tablets
  • lormetazepam 1mg tablets
  • lormetazepam 500microgram tablets
  • Therapeutic Indications


    Insomnia (short-term treatment)


    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.


    0.5 mg to 1.5 mg daily at bedtime.

    This dose may be increased in individual cases if deemed necessary.


    0.5 mg daily at bedtime.

    Additional Dosage Information

    Duration of treatment varies from a few days to two weeks, with a maximum of four weeks, including the tapering off process. Extension beyond the maximum treatment period may be necessary but should not take place without re-evaluation of the patient's status; specialist help may be appropriate. Long-term chronic use is not recommended as there is little data on the efficacy or safety of benzodiazepines in long-term use.
    Patients who have taken benzodiazepines chronically may require a longer tapering off period.


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

    Precautions and Warnings

    Predisposition to seizures
    Suicidal ideation
    Acute narrow angle glaucoma
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    History of alcohol abuse
    History of drug misuse
    Lactose intolerance
    Personality disorder
    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


    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 ( ) or if this is unavailable at the backup site ( ).


    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

    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.


    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

    Allergic dermatitis
    Altered liver function tests
    Anaphylactoid reaction
    Anterograde amnesia
    Behavioural disturbances
    Blood disorders
    Changes in libido
    Disturbances of appetite
    Drowsiness and light-headedness (next day)
    Extrapyramidal effects
    Gastro-intestinal symptoms
    Hypersensitivity reactions
    Impaired memory
    Inappropriate secretion of antidiuretic hormone
    Increased hostility and aggression (paradoxical)
    Muscle weakness
    Numbed emotions
    Paradoxical reactions
    Pre-existing depression may be unmasked
    Reduced alertness
    Respiratory depression
    Salivation changes
    Sexual disturbances
    Sleep disturbances
    Slurred speech
    Suicidal tendencies
    Urinary retention
    Visual disturbances


    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 ( ) or if this is unavailable at the backup site ( ).

    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 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
    Available at:!scenariorecommendation
    Last accessed: June 20, 2014

    Committee on Safety of Medicines/Medicines Control Agency. Current problems in Pharmacovigilance (1997); 23: 10
    Available at:
    Reminder: avoid benzodiazepines in pregnancy and lactation .
    Last accessed: June 20, 2014. 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: Last accessed: 6 January 2015 New drug driving offence implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: Last accessed: 6 January 2015

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