effective, the dose can be increased. The maximum recommended dose of BELSOMRA is 20 mg once daily.
2.2 Special Populations
Exposure to BELSOMRA is increased in obese compared to non-obese patients, and in women compared to men. Particularly in obese women, the increased risk of exposure-related adverse effects should be considered before increasing the dose [see Clinical Pharmacology (12.3)].
2.3 Use with CNS Depressants
When BELSOMRA is combined with other CNS depressant drugs, dosage adjustment of BELSOMRA and/or the other drug(s) may be necessary because of potentially additive effects [see Warnings and Precautions (5.1)].
2.4 Use with CYP3A Inhibitors
The recommended dose of BELSOMRA is 5 mg when used with moderate CYP3A inhibitors and the dose generally should not exceed 10 mg in these patients. BELSOMRA is not recommended for use with strong CYP3A inhibitors [see Drug Interactions (7.2)].
2.5 Food Effect
Time to effect of BELSOMRA may be delayed if taken with or soon after a meal.
3 DOSAGE FORMS AND STRENGTHS
5mg tablets are yellow, round, film-coated tablets with "5" on one side and plain on the other side.
10mg tablets are green, round, film-coated tablets with "33" on one side and plain on the other side.
15mg tablets are white, oval, film-coated tablets with the Merck logo on one side and "325" on the other side.
20mg tablets are white, round, film-coated tablets with the Merck logo and "335" on one side and plain on the other side.
4 CONTRAINDICATIONS
BELSOMRA is contraindicated in patients with narcolepsy.
5 WARNINGS AND PRECAUTIONS
5.1 CNS Depressant Effects and Daytime Impairment
BELSOMRA is a central nervous system (CNS) depressant that can impair daytime wakefulness even when used as prescribed. Prescribers should monitor for somnolence and CNS depressant effects, but impairment can occur in the absence of symptoms, and may not be reliably detected by ordinary clinical exam (i.e., less than formal testing of daytime wakefulness and/or psychomotor performance). CNS depressant effects may persist in some patients for up to several days after discontinuing BELSOMRA.
BELSOMRA can impair driving skills and may increase the risk of falling asleep while driving. Discontinue or decrease the dose in patients who drive if daytime somnolence develops. In a study of healthy adults, driving ability was impaired in some individuals taking 20 mg BELSOMRA [see Clinical Studies (14.2)]. Although pharmacodynamic tolerance or adaptation to some adverse depressant effects of BELSOMRA may develop with daily use, patients using the 20 mg dose of BELSOMRA should be cautioned against next-day driving and other activities requiring full mental alertness. Patients taking lower doses of BELSOMRA should also be cautioned about the potential for driving impairment because there is individual variation in sensitivity to BELSOMRA.
Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression. Patients should be advised not to consume alcohol in combination with BELSOMRA because of additive effects [see Drug Interactions (7.1)]. Dosage adjustments of BELSOMRA and of concomitant CNS depressants may be necessary when administered together because of potentially additive effects. The use of BELSOMRA with other drugs to treat insomnia is not recommended [see Dosage and Administration (2.3)].
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