BELSOMRA
Pronunciation: soo-voe-REX-ant (bel-SOM-ra)


What it isDual OX1 and OX2 orexin-receptor antagonist; insomnia.
Why this oneAs the first dual orexin antagonist, it established a non-GABAergic option for both sleep onset and maintenance.
What limits itNext-day somnolence requires adequate sleep time; CYP3A4 interactions, falls, and Schedule IV misuse risk remain.
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| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Insomnia (sleep onset and/or maintenance) | Adults | 10 mg QHS | 10 mg QHS | 20 mg QHS |
| Insomnia, with moderate CYP3A inhibitor | Adults | 5 mg QHS | 5 mg QHS | 10 mg QHS |
Renal No adjustment needed
Hepatic Mild-moderate: no adjustment; severe: not recommended
No more than once per night; obese women have higher exposure — consider before dose increase
Available strengths
Pregnancy Insufficient human data; animal studies showed decreased maternal/fetal weight
Lactation Present in breast milk at low concentrations (relative infant dose <1%)
| Strength | #/mo | generic $/mo | brand $/mo | CostPlus | |
|---|---|---|---|---|---|
| 5 mg | tab | 30 qd | — | $456.04 | not offered |
| 10 mg | tab | 30 qd | — | $456.38 | not offered |
| 15 mg | tab | 30 qd | — | $455.72 | not offered |
| 20 mg | tab | 30 qd | — | $456.16 | not offered |
Generic entry2029 est.
NO BOXED WARNINGS
Principal riskNext-day somnolence; allow seven hours before waking
Legacy pregnancy categoryC
Defining liabilityNext-day somnolence, abnormal sleep behaviors and additive CNS depression.
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