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Drug Details

DALMANE Capsules

• Drug Class Description
  Long-acting benzodiazepines (hypnotics).
• Generic Name
  Flurazepam
• Presentation
  Dalmane 15 mg Capsules - Capsules with opaque grey cap and opaque yellow body with ICN 15 printed in red on both cap and body, containing 16.4 mg flurazepam monohydrochloride (equivalent to 15 mg flurazepam). Dalmane 30 mg Capsules - Capsules with black cap and opaque grey body with ICN 30 printed in red on both cap and body, containing 32.8 mg flurazepam monohydrochloride (equivalent to 30 mg flurazepam
• Description
  Capsules
• Indications
  

  Short-term treatment of insomnia when it is severe, disabling or subjecting the individual to extreme distress. Dalmane is helpful in overcoming difficulties in getting to sleep and also in the problem of frequent nocturnal awakenings. Its properties make it particularly indicated where the total duration of sleep is less than adequate.

  An underlying cause for insomnia should be sought before deciding upon the use of benzodiazepines for symptomatic relief. Benzodiazepines are not recommended for the primary treatment of psychotic illness.

• Adult Dosage
  

  The dosage of Dalmane should be determined on an individual basis taking into account the severity of the insomnia and the patient's response to treatment. Dosage is important in determining the duration of effect and the occurrence of residual effects.

  For most patients the optimum dose if 15 mg – this will ensure a full night's sleep with minimal residual effects on wakening. Patients with severe insomnia may require 30 mg but residual effects on awakening, associated with an anxiolytic effect, are more frequent at this dose.

• Child Dosage
  

  Dalmane is contra-indicated for use in children.

  Treatment should, if possible, be on an intermittent basis.

  Treatment should be as short as possible and should be started with the lowest recommended dose. The maximum dose should not be exceeded. Generally the duration of treatment varies from a few days to two weeks with a maximum of four weeks, including the tapering off process. Patients who have taken benzodiazepines for a prolonged time may require a longer period during which doses are reduced. Specialist help may be appropriate. Little is known regarding the efficacy or safety of benzodiazepines in long-term use.

  In certain cases, extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient's status. Long-term chronic use is not recommended.

  The product should be taken just before going to bed.

  Dalmane capsules are for oral administration.

• Elderly Dosage
  

  Elderly or debilitated patients: the elderly or patients with impaired renal and/or hepatic function will be particularly susceptible to the adverse effects of Dalmane. The initial dose should not exceed 15 mg. If organic brain changes are present, the dosage of Dalmane should not exceed 15 mg in these patients.

  In patients with chronic pulmonary insufficiency and in patients which chronic renal or hepatic disease, dosage may need to be reduced.

• Contra Indications
  

  Patients with known sensitivity to benzodiazepines; acute pulmonary insufficiency; respiratory depression; phobic or obsessional states; chronic psychosis; myasthenia gravis; sleep apnoea syndrome; severe hepatic insufficiency; use in children.

  Use of this drug is contra-indicated in patients with a known hypersensitivity to benzodiazepines and any of the excipients. Hypersensitivity reactions with the benzodiazepines including rash, angioedema and hypotension have been reported on rare occasions in susceptible patients.

• Special Precautions
  

  In patients with chronic pulmonary insufficiency, and in patients with chronic renal or hepatic disease, dosage may need to be reduced.

  Dalmane should not be used alone to treat depression or anxiety associated with depression, since suicide may be precipitated in such patients.

  In cases of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines.

  If the patient is awoken during the period of maximum drug activity, recall may be impaired.

  Use of benzodiazepines may lead to the development of physical and psychological dependence. The dependence potential of the benzodiazepines is low, particularly when limited to short-term use, but this increases when high doses are used, especially when given over long periods. This is particularly so in patients with a history of alcoholism or drug abuse or in patients with marked personality disorders. Regular monitoring in such patients is essential, routine repeat prescriptions should be avoided and treatment should be withdrawn gradually. Symptoms such as depression, nervousness, extreme anxiety, tension, restlessness, confusion, mood changes, rebound insomnia, irritability, sweating, diarrhoea, headaches and muscle pain have been reported following abrupt cessation of treatment in patients receiving even normal therapeutic doses for short periods of time.

  In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact and hallucinations or epileptic seizures. In rare instances, withdrawal following excessive dosages may produce confusional states, psychotic manifestations and convulsions. Abuse of the benzodiazepines has been reported.

  Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines may develop after repeated use for a few weeks.

  Abnormal psychological reactions to benzodiazepines have been reported. Rare behavioural effects include paradoxical aggressive outbursts, excitement, confusion, restlessness, agitation, irritability, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and the uncovering of depression with suicidal tendencies. Extreme caution should therefore be used in prescribing benzodiazepines to patients with personality disorders. If any of these reactions occur, use of the drug should be discontinued. These reactions may be quite severe and are more likely to occur in children and the elderly.

  Benzodiazepines may induce anterograde amnesia. The condition usually occurs 1-2 hours after ingesting the product and may last up to several hours. Therefore, to reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of 7 to 8 hours.

• Interactions
  

  Enhancement of the central depressive effect may occur if benzodiazepines are combined with centrally-acting drugs such as neuroleptics, tranquilisers, antidepressants, hypnotics, analgesics, enhancement of the euphoria may also occur leading to an increase in psychological dependence. The elderly require special supervision.

  When Dalmane is used in conjunction with anti-epileptic drugs, side-effects and toxicity may be more evident, particularly with hydantoins or barbiturates or combinations including them. This requires extra care in adjusting dosage in the initial stages of treatment.

  Known inhibitors of hepatic enzymes, eg cimetidine, have been shown to reduce the clearance of benzodiazepines and may potentiate their action and known inducers of hepatic enzymes, eg rifampicin, may increase the clearance of benzodiazepines.

  Concomitant intake with alcohol should be avoided. The sedative effect may be enhanced when the product is used in combination with alcohol. This adversely affects the ability to drive or use machines.

• Adverse Drug Reactions
  

  Common adverse effects include drowsiness during the day, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia and double vision. These phenomena are dose-related and are likely to be uncommon with the recommended dosage; they occur predominantly at the start of therapy and usually disappear with repeated administration. The elderly are particularly sensitive to the effects of centrally depressant drugs.

  Other adverse effects are rare and include vertigo, hypotension, gastro-intestinal upsets, skin rashes, visual disturbances, changes in libido, and urinary retention. Isolated cases of blood dyscrasias and jaundice have also been reported.

  Occasionally patients treated with Dalmane experience a bitter after-taste.