GOLD CROSS

What it is

Gold Cross SleepWell contains doxylamine succinate 25 mg per tablet. Doxylamine succinate is an antihistamine of the ethanolamine class with pronounced sedative and antimuscarinic effects. The tablets are white and concave with a break bar on one side.

Approved indications

— Temporary relief of sleeplessness.

Dosing overview

For adults and children over 12 years, the dose is 1 or 2 tablets with water 20 minutes before retiring.

Key safety warnings

Doxylamine succinate may cause drowsiness in some patients, and such patients should avoid operating vehicles or machinery or engaging in activities which require them to be fully alert. Alcohol should be avoided. Doxylamine succinate may enhance the sedative effect of other central nervous system depressants such as opioid analgesics, neuroleptics, alcohol, hypnotics and psychotherapeutic drugs. Antihistamines may cause dry mouth, dizziness, gastrointestinal disturbances, blurred vision, urinary difficulty and retention, paradoxical central nervous system stimulation (insomnia, nervousness, euphoria, irritability, tremors, nightmares, hallucinations and convulsions), and tachycardia. Epigastric distress, thickening of bronchial secretions and hypersensitivity reactions have also been reported. Rarely, blood disorders, hypotension, tinnitus, headache and paraesthesia may occur. Gold Cross SleepWell should not be given to breastfeeding women, as it may inhibit lactation and doxylamine succinate may be excreted in human milk.

Contraindications

Gold Cross SleepWell is contraindicated in epilepsy, narrow angle glaucoma and known hypersensitivity to doxylamine succinate or to any other ingredients in the product.

Regulatory history

Gold Cross SleepWell (ARTG 171259) was first listed on the Australian Register of Therapeutic Goods on 11 May 2010.