It shortens the sleep induction period , reduces the frequency of night waking and prolongs the sleep time.
Mechanism of action
It binds specifically and with high affinity to benzodiazepine receptors in the CNS. It shortens the sleep induction period, reduces the frequency of awakening and prolongs the sleep time.
Therapeutic indications
Treatment of insomnia that requires pharmacological intervention.
Contraindications
Hypersensitivity to brotizolam or other benzodiazepines, myasthenia gravis, insuff. severe respiratory, sleep apnea syndrome, severe IH.
Warnings and cautions
Elderly, IR, IH, insuff. Respiratory with hypercapnia, history of alcohol or drug dependence, children. Risk of inducing anterograde amnesia, psychiatric and paradoxical reactions (more frequent in children and the elderly). After continued use there is a risk of tolerance, physical and mental dependence. Abrupt discontinuation after continued use causes withdrawal syndrome. Do not use in anxiety associated with depression or as a treatment. primary of enf. psychotic.
Liver failure
Contraindicated in severe IH due to associated risk of encephalopathy. Caution in mild to moderate HI, reduce dose.
Renal insufficiency
Caution. Special attention when individualizing doses.
Interactions
Effect increased by: neuroleptics, hypnotics, anxiolytics, sedatives, antidepressants, opioid analgesics, antiepileptics, anesthetics, sedative antihistamines, inhibitors of CYP3A4 enzyme activity. Activity reduced by: inducers the enzymatic activity of CYP3A4.
Pregnancy
Efficacy and safety not established. If taken in late stages, children may have withdrawal symptoms.
Lactation
To avoid. Efficacy and safety have not been established.
Effects on the ability to drive
It can produce sedation, amnesia and muscle function disorder negatively influences the ability to drive.
Adverse reactions
Drowsiness by day, sore head , gastrointestinal disturbances, amnesia , psychiatric and paradoxical reactions.
Overdose
In case of overdose, deep sleep may occur, which can reach a coma, depending on the amount of medicine ingested. This is usually not life threatening if barbiturates and / or alcohol have not been ingested concomitantly.
The flumazenil can be useful as an antidote. In case of an overdose, call your local emergency services
Additional Information
Physical and mental dependence can develop.
One of the initial symptoms of the development of dependence is the presentation of rebound phenomena, with potentiation of the symptoms that led to the use of benzodiazepines, in association with emotional disturbances, anxiety and agitation. The safety of use during pregnancy and lactation has not been demonstrated. That is why it is not recommended in these circumstances.
It should not be used to treat depression and anxiety associated with depression, as suicidal behavior can be triggered in such patients. Brotizolam should not be used in patients with a history of alcohol or drug abuse. Sedation, amnesia, and impaired muscle function are adverse effects that can affect the ability to drive or use heavy machinery. The concomitant use of alcohol and / or CNS depressant drugs can potentiate these alterations. If the duration of sleep is insufficient, the ability to maintain alertness may be impaired. Its sale requires a prescription, which will be retained at the pharmacy.