Approved Drug Label (PDF)
8
Use in Specific Populations
8.2 Lactation
Additions and/or revisions underlined:
Risk
Summary
Suvorexant
and its metabolite, hydroxy suvorexant, are present in low concentrations in
breast milk with a relative infant dose of less than 1% following maternal oral
administration (see Data). There are no data
on the effects of suvorexant on the breastfed infant, or the effects on milk
production.
The
developmental and health benefits of breastfeeding should be considered along
with the mother’s clinical need for BELSOMRA and any potential adverse effects
on the breastfed infant from BELSOMRA or from the underlying maternal
condition.
Data
A
single dose (20 mg) milk and plasma lactation study was conducted in 12 healthy
lactating women. The mean amount of suvorexant recovered in breast milk was
0.011 mg following a 20 mg maternal dose. The calculated mean daily infant dose
was 0.002 mg/kg/day based on the actual infant body weight (i.e., 6.2 kg). The
relative infant dose is less than 1% of the maternal dose. Approximately 82% of
the amount of suvorexant excreted in breast milk was excreted by 24 hours after
a single maternal dose administration.
Suvorexant
and its metabolite, hydroxy suvorexant, are present in breast milk and the
transfer of hydroxy suvorexant into breast milk is lower than suvorexant
(metabolite/parent: 0.13).
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions and/or revisions underlined:
What should I tell
my doctor before taking BELSOMRA?
Before taking
BELSOMRA, tell your doctor about all of your medical conditions, including if
you:
…
Approved Drug Label (PDF)
6
Adverse Reactions
6.2 Post-Marketing Experience
(Additions and/or revisions underlined)
The following adverse reactions
have been identified during post-approval use of BELSOMRA.
Because these reactions
are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate
their frequency or establish
a causal relationship
to drug
exposure.
Cardiac disorders: palpitations, tachycardia
Gastrointestinal
disorders: nausea, vomiting
Approved Drug Label (PDF)
6
Adverse Reactions
6.2 Postmarketing Experience
(Additions and/or
revisions underlined)
The
following adverse reactions have been identified during post-approval use of BELSOMRA.
Because these reactions are reported voluntarily from a population of uncertain
size, it is not always possible to reliably estimate their frequency or establish
a causal relationship to drug exposure.
Cardiac disorders: palpitations,
tachycardia
Nervous system disorders: psychomotor hyperactivity
Psychiatric disorders: anxiety
Skin and subcutaneous
tissue disorders: pruritus
Approved Drug Label (PDF)
5
Warnings and Precautions
CNS Depressant Effects and Daytime Impairment
(Newly added information)
Because BELSOMRA can cause
drowsiness, patients, particularly the elderly, are at higher risk of falls.
Complex Sleep Behaviors
(New subsection added)
Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake (e.g., preparing and eating
food, making phone calls, having sex), have been reported to occur with the use of hypnotics such as BELSOMRA. These events can occur in hypnotic-naïve as well as in hypnotic-experienced persons. Patients usually do not remember these events. Complex sleep behaviors may occur following
the first or any subsequent use of BELSOMRA, with or without
the concomitant use of alcohol and other CNS depressants [see Drug Interactions (7.1)]. Discontinue BELSOMRA immediately if a
patient experiences a complex sleep behavior.
6
Adverse Reactions
(Additions and/or
revisions underlined)
The following serious adverse
reactions are discussed in greater detail in other sections:
· CNS
Depressant Effects
and Daytime Impairment [see Warnings and
Precautions (5.1)]
· Worsening of Depression/Suicidal Ideation [see Warnings and Precautions
(5.2)]
· Complex Sleep Behaviors [see Warnings and Precautions (5.3)]
· Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, Cataplexy-Like Symptoms [see Warnings
and Precautions (5.4)]
· Patients with Compromised Respiratory Function [see
Warnings and Precautions (5.5)]
Insomnia Study in Patients with Mild to Moderate Alzheimer’s Disease
(New subsection added)
In
a 4-week insomnia study of BELSOMRA in
285 patients (BELSOMRA n=142; placebo n=143) with mild to moderate
Alzheimer’s Disease, the adverse
reactions occurring ?2% and greater than placebo were somnolence (4% compared to 1% for placebo),
dry mouth (2% compared to 1% for placebo),
and falls (2% compared to 0% for placebo) [see Clinical Studies (14.1)].
7
Drug Interactions
Effects of Other Drugs on BELSOMRA
(Additions and/or
revisions underlined)
The dose generally should not exceed 10 mg in patients
receiving moderate
CYP3A inhibitors [see Clinical
Pharmacology (12.3)].
8
Use in Specific Populations
Geriatric Use
(Newly added information)
Because BELSOMRA
can increase drowsiness, patients, particularly the elderly, are at a higher risk of falls
[see Warnings and Precautions (5.1)].
Lactation
(PLLR conversion.
Please refer to label for complete information.)
Pregnancy
(PLLR conversion.
Please refer to label for complete information.)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
(Additions and/or
revisions underlined)
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.
Talk to your healthcare provider about the risk to your
unborn baby if you take BELSOMRA during pregnancy.
Talk to your healthcare provider about the best way to
feed your baby during treatment with BELSOMRA.
BELSOMRA may cause serious side effects including:
·
worsening depression and suicidal thoughts have
happened during treatment with BELSOMRA. Call your healthcare provider right
away if you have any worsening depression or thoughts of suicide or dying.
·
complex sleep behaviors such as
sleep-walking, sleep-driving, preparing and eating food, making phone calls,
having sex or doing other activities while not fully awake that you may not
remember the next morning. Call your healthcare provider right away if you
experience a complex sleep behavior.
PATIENT COUNSELING INFORMATION
(Newly added information)
Advise patients that increased
drowsiness may increase the risk of falls in some patients
[see Warnings and Precautions (5.1)].
Approved Drug Label (PDF)
6
Adverse Reactions
Newly
created subsection:
6.2
Post-Marketing Experience
The following adverse reactions have been
identified during post-approval use of BELSOMRA. Because these reactions are
reported voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or establish a causal
relationship to drug exposure.
Cardiac
disorders:
palpitations, tachycardia
Nervous
system disorders:
psychomotor hyperactivity
Psychiatric
disorders:
anxiety
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