BELSOMRA- suvorexant tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

suvorexant (UNII: 081L192FO9) (suvorexant - UNII:081L192FO9)

Available from:

Merck Sharp & Dohme LLC

INN (International Name):

suvorexant

Composition:

suvorexant 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

BELSOMRA tablets, 5 mg, are yellow, round, film-coated tablets, with "5" on one side and plain on the other side. They are supplied as follows: NDC 0006-0005-30 unit-of-use blisters of 30 BELSOMRA tablets, 10 mg, are green, round, film-coated tablets, with "33" on one side and plain on the other side. They are supplied as follows: NDC 0006-0033-30 unit-of-use blisters of 30 BELSOMRA tablets, 15 mg, are white, oval, film-coated tablets with the Merck logo on one side and "325" on the other side. They are supplied as follows: NDC 0006-0325-30 unit-of-use blisters of 30 BELSOMRA tablets, 20 mg, are white, round, film-coated tablets with the Merck logo and "335" on one side and plain on the other side. They are supplied as follows: NDC 0006-0335-30 unit-of-use blisters of 30 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F), [see USP Controlled Room Temperature]. Store in the original package until use to protect from light and moisture.

Authorization status:

New Drug Application

Patient Information leaflet

Merck Sharp & Dohme LLC
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: 2/2023
MEDICATION GUIDE
BELSOMRA® (bell-SOM-rah)
suvorexant
Tablets C-IV
What is the most important information I should know about BELSOMRA?
BELSOMRA may cause serious side effects including:
•
Decreased awareness and alertness. The morning after you take
BELSOMRA, your ability to
drive safely and think clearly may be decreased. You may also have
sleepiness during the day.
•
Do not take more BELSOMRA than prescribed.
•
Do not take BELSOMRA unless you are able to stay in bed a full night
(at least 7 hours)
before you must be active again.
•
Take BELSOMRA within 30 minutes of going to bed.
See "What are the possible side effects of BELSOMRA?" for more
information about side effects.
What is BELSOMRA?
•
BELSOMRA is a prescription medicine for adults who have trouble
falling or staying asleep
(insomnia).
•
It is not known if BELSOMRA is safe and effective in children under
the age of 18.
BELSOMRA is a federally controlled substance (C-IV) because it can be
abused or cause dependence.
Keep BELSOMRA in a safe place to prevent misuse and abuse. Selling or
giving away BELSOMRA
may harm others and is against the law. Tell your doctor if you have
ever abused or have been dependent
on alcohol, prescription medicines or street drugs.
Who should not take BELSOMRA?
Do not take BELSOMRA if you fall asleep often at unexpected times
(narcolepsy).
What should I tell my doctor before taking BELSOMRA?
Before taking BELSOMRA, tell your doctor about all of your medical
conditions, including if you:
•
have a history of depression, mental illness, or suicidal thoughts
•
have a history of drug or alcohol abuse or addiction
•
have a history of a sudden onset of muscle weakness (cataplexy)
•
have a history of falling asleep often at unexpected times
(narcolepsy) or daytime sleepiness
•
have lung problems or breathing problems
•
have liver problems
•
are pregnant or plan to become pregnant

Summary of Product characteristics

BELSOMRA- SUVOREXANT TABLET, FILM COATED
MERCK SHARP & DOHME LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BELSOMRA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BELSOMRA.
BELSOMRA (SUVOREXANT) TABLETS, FOR ORAL USE, C-IV
INITIAL U.S. APPROVAL: 2014
INDICATIONS AND USAGE
BELSOMRA is an orexin receptor antagonist indicated for the treatment
of insomnia, characterized by
difficulties with sleep onset and/or sleep maintenance (1).
DOSAGE AND ADMINISTRATION
Use the lowest dose effective for the patient (2.1).
Recommended dose is 10 mg, no more than once per night taken within 30
minutes of going to bed,
with at least 7 hours remaining before the planned time of awakening.
If the 10 mg dose is well-
tolerated but not effective, the dose can be increased, not to exceed
20 mg once daily (2.1, 2.2).
Time to effect may be delayed if taken with or soon after a meal
(2.1).
DOSAGE FORMS AND STRENGTHS
Tablets, 5 mg, 10 mg, 15 mg, 20 mg (3).
CONTRAINDICATIONS
BELSOMRA is contraindicated in patients with narcolepsy (4).
WARNINGS AND PRECAUTIONS
CNS Depressant Effects and Daytime Impairment: Risk of impaired
alertness and motor coordination,
including impaired driving; risk increases with dose; caution patients
taking 20 mg against next-day
driving and other activities requiring complete mental alertness
(5.1).
Worsening of Depression/Suicidal Ideation: Worsening of depression or
suicidal thinking may occur. Risk
increases with dose. Immediately evaluate any new behavioral changes
(5.2).
Complex Sleep Behaviors: Behaviors including sleep-walking,
sleep-driving, and engaging in other
activities while not fully awake may occur. Discontinue immediately if
a complex sleep behavior occurs
(5.3).
Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and
Cataplexy-like Symptoms: May occur
with the use of BELSOMRA. Risk increases with dose (5.4).
Compromised Respiratory Function: Effect on respiratory function
should be considered (5.5, 8.6).
Need