BELSOMRA

What it is

BELSOMRA is a medicine containing the active ingredient suvorexant, available as film-coated tablets for oral use containing 15 or 20 mg of suvorexant. Suvorexant is a highly selective reversible high affinity orexin receptor antagonist. The orexin neuropeptide signalling system is a central promoter of wakefulness, and blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors is thought to suppress wake drive.

Approved indications

— Treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance.

Dosing overview

The recommended dose is 20 mg for non-elderly adults (less than 65 years) and 15 mg for elderly adults (65 years or older). BELSOMRA should be taken no more than once per night and within 30 minutes of going to bed, with at least 7 hours remaining before the planned time of awakening. BELSOMRA may be taken with or without food.

Key safety warnings

BELSOMRA is a central nervous system depressant that can impair daytime wakefulness even when used as prescribed, and can impair driving skills and may increase the risk of falling asleep while driving. CNS depressant effects may persist in some patients for up to several days after discontinuing BELSOMRA. In clinical studies, a dose-dependent increase in suicidal ideation was observed in patients taking BELSOMRA as assessed by questionnaire. Patients with suicidal ideation or any new behavioural sign or symptom should be immediately evaluated. Sleep paralysis, an inability to move or speak for up to several minutes during sleep-wake transitions, and hypnagogic/hypnopompic hallucinations, including vivid and disturbing perceptions by the patient, can occur with the use of BELSOMRA, and prescribers should explain the nature of these events to patients when prescribing BELSOMRA. Symptoms similar to mild cataplexy can occur, with risk increasing with the dose of BELSOMRA, including periods of leg weakness lasting from seconds to a few minutes. BELSOMRA has not been studied in patients with severe obstructive sleep apnoea or severe chronic obstructive pulmonary disease, and caution is advised if BELSOMRA is prescribed to patients with compromised respiratory function.

Contraindications

BELSOMRA is contraindicated in patients with known hypersensitivity to suvorexant or any of its inactive ingredients. BELSOMRA is contraindicated in patients with narcolepsy.

Regulatory history

BELSOMRA 20 mg tablets and BELSOMRA 15 mg tablets were first listed on the Australian Register of Therapeutic Goods on 16 November 2016. The TGA initially rejected suvorexant for all proposed doses; however, following an appeal to the Administrative Appeals Tribunal, the drug was approved for the 15 mg and 20 mg doses on 11 November 2016. The clinical evaluator concluded that the efficacy of suvorexant for the treatment of insomnia was demonstrated in the pivotal studies for doses of 15 mg and 20 mg, and the safety profile was considered acceptable for these doses.