Source: Health Products Regulatory Authority (ZA) Revision Year: 2019 Publisher: Sanofi-aventis south africa (pty) ltd, 2 Bond Street, Midrand, 1685, South Africa
DORMONOCT is only indicated when the disorder is severe, disabling or when the individual is subject to extreme stress.
The usual adult dose is 1-2 mg at bedtime, the higher dose being recommended for patients who have previously been treated with benzodiazepines for severe persistent insomnia. An initial dose of 0,5 mg-1,0 mg is recommended in elderly and debilitated patients. The 2 mg tablet may not be suitable for use as initiation, in elderly patients and patients with renal, hepatic or moderate respiratory insufficiency.
Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded.
Treatment should be as short as possible. Generally, the duration of treatment varies from a few days to two weeks, with a maximum of four weeks including the tapering-off process. 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.
It is strongly recommended that after prolonged treatment DORMONOCT is not withdrawn suddenly but rather that the dose is reduced gradually under medical supervision; otherwise withdrawal symptoms may occur (see WARNINGS AND SPECIAL PRECAUTIONS).
DORMONOCT should be taken half an hour before bedtime. Tablets are to be swallowed without chewing, with sufficient amount of liquids.
Manifestations of overdosage include somnolence, confusion, coma, respiratory and cardiovascular depression and hypotension.
Intravenous fluids should be administered and an adequate airway maintained. Treatment is supportive and symptomatic and gastric lavage may be of use if performed within 12 hours of ingestion.
Store at or below 25°C.
Protect from light, heat and humidity. Keep tablets in blister pack until required for use.
KEEP OUT OF REACH OF CHILDREN.
2 mg tablets packed in blister packs of 30’s and 100’s.
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