Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - suvorexant, quantity: 20 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; copovidone; magnesium stearate; croscarmellose sodium; titanium dioxide; hypromellose; triacetin - belsomra is indicated for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance. following initiation of treatment, continuation should be re-evaluated after 3 months [see pharmacodynamic properties, clinical trials and adverse effects (undesirable effects) for clinical trial durations].

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - suvorexant, quantity: 20 mg - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; copovidone; croscarmellose sodium; titanium dioxide; hypromellose; triacetin - silumbra is indicated for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance. following initiation of treatment, continuation should be re-evaluated after 3 months [see pharmacodynamic properties, clinical trials and adverse effects (undesirable effects) for clinical trial durations].

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - suvorexant, quantity: 15 mg - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; copovidone; microcrystalline cellulose; croscarmellose sodium; titanium dioxide; hypromellose; triacetin - belsomra is indicated for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance.,following initiation of treatment, continuation should be re-evaluated after 3 months [see pharmacodynamic properties, clinical trials and adverse effects (undesirable effects) for clinical trial durations].

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - suvorexant, quantity: 15 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; magnesium stearate; croscarmellose sodium; lactose monohydrate; copovidone; titanium dioxide; hypromellose; triacetin - silumbra is indicated for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance. following initiation of treatment, continuation should be re-evaluated after 3 months [see pharmacodynamic properties, clinical trials and adverse effects (undesirable effects) for clinical trial durations].

United States - English - NLM (National Library of Medicine)

merck sharp & dohme llc - suvorexant (unii: 081l192fo9) (suvorexant - unii:081l192fo9) - suvorexant 5 mg - belsomra® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. belsomra is contraindicated in patients with narcolepsy. risk summary available data from postmarketing reports with belsomra use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of suvorexant to pregnant rats and rabbits during the period of organogenesis decreased maternal body weight and/or weight gain at doses ≥ 30 and 28 times the maximum recommended human dose (mrhd) of 20 mg based on auc in the rat and rabbit, respectively. suvorexant caused decreased fetal weight at doses ≥ 86 times the mrhd based on auc in the rat and did not cause significant fetal toxicity at doses up to 28 times the mrhd based on auc in the rabbit. the no observed adverse effect levels (noaels) for fetal toxicity are 25 and 28 times the mrhd based

Canada - English - Health Canada

merck canada inc - suvorexant - tablet - 5mg - suvorexant 5mg - miscellaneous anxiolytics sedatives and hypnotics

Canada - English - Health Canada

merck canada inc - suvorexant - tablet - 10mg - suvorexant 10mg - miscellaneous anxiolytics sedatives and hypnotics

Canada - English - Health Canada

merck canada inc - suvorexant - tablet - 15mg - suvorexant 15mg - miscellaneous anxiolytics sedatives and hypnotics

Canada - English - Health Canada

merck canada inc - suvorexant - tablet - 20mg - suvorexant 20mg - miscellaneous anxiolytics sedatives and hypnotics

Bangladesh - English - DGDA (Directorate General of Drug Administration)

eskayef pharmaceuticals ltd., tongi,gazipur - suvorexant - tablet - 10 mg