Nalmefene

Nalmefene is currently not available in Australia. Nalmefene is an opioid receptor antagonist that has a comparable chemical structure to naltrexone. Nalmefene is a selective opioid receptor ligand with antagonist activity at the µ and d receptors and also has partial agonist activity at the ? receptor.  

Nalmefene is the first pharmacotherapy for the management of AUD that has been approved by the Therapeutic Goods Administration (TGA) specifically for pharmacologically controlled drinking. Nalmefene shows some superiority over placebo for reducing alcohol consumption. However, more research is needed until we make a recommendation in line with TGA approval regarding the use of nalmefene for the management of controlled drinking. Nalmefene is not listed on the PBS.

Nalmefene is approved by the TGA to reduce high levels of alcohol consumption in adult patients with moderate to severe AUD. Nalmefene should be prescribed in conjunction with continuing psychosocial support focused on treatment adherence and reducing alcohol consumption. Nalmefene is not suitable for patients with physical withdrawal syndrome or who require immediate detoxification.

Nalmefene induces precipitated opiate withdrawal in patients who are currently opiate dependent. It is contraindicated in patients with current or recent use of opioid medication. Nalmefene is contraindicated in patients with a known hypersensitivity to the drug or renal insufficiency.

Nalmefene does not compromise liver function. However, use of nalmefene in patients with severe hepatic impairment is contraindicated (Child-Pugh class C). The use of nalmefene is contraindicated in pregnant women and during lactation. 

Nalmefene should be discontinued 1 week prior to any situation where opioid analgesia may be required (e.g. in patients undergoing elective surgery). In an emergency situation when opioids must be administered to a patient taking nalmefene, the amount of opioid required to obtain the desired effect may be greater than usual.

Nalmefene is the first pharmacotherapy in the management of AUD whose indication is pharmacologically controlled drinking, thus it is indicated that treatment starts when patients are still actively drinking and with concomitant psychotherapy.

The starting and recommended dose for nalmefene is one tablet (18 mg) per day. Nalmefene is to be taken as needed: on each day the patient perceives a risk of drinking alcohol; one tablet should be taken, preferably 1-2 hours prior to the anticipated time of drinking. If the patient has started drinking alcohol without taking nalmefene, the patient should take one tablet as soon as possible.

The most appropriate duration of treatment continuation in patients with moderate to severe AUD is not yet known but the usual duration is 3 months. However, the decision regarding treatment duration should be made on a case-by-case basis between the patient and doctor. This will be based on side effects, history of relapse, social and family circumstances, and other individual factors.

Common side include a higher risk of dizziness, headache, insomnia, nausea and vomiting.