FDA Approves BELSOMRA® (suvorexant) for the Treatment of Insomnia


August 13, 2014 3:49 pm ET

BELSOMRA expected to be available in late 2014 or early 2015

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
announced today that the U.S. Food and Drug Administration (FDA) has
approved BELSOMRA® (suvorexant) for adults with insomnia who
have difficulty falling asleep and/or staying asleep. BELSOMRA
(pronounced bell-SOM-rah) is a highly selective antagonist for orexin
receptors. Orexin is a neurotransmitter found in a specific part of the
brain that can help keep a person awake. The mechanism by which BELSOMRA
exerts its therapeutic effect is presumed to be through antagonism of
orexin receptors. In the clinical trials to support efficacy, BELSOMRA
was superior to placebo for sleep latency and sleep maintenance as
assessed both objectively by polysomnography and subjectively by
patient-estimated sleep latency. The recommended dose of BELSOMRA is 10
mg, taken no more than once per night and within 30 minutes of going to
bed, with at least 7 hours remaining before the planned time of
awakening. The total dose should not exceed 20 mg once daily.

“Today’s approval of BELSOMRA allows for the introduction of a new
treatment option for patients suffering from insomnia,” said Dr. David
Michelson, vice president, Neurosciences, Merck Research Laboratories.
“BELSOMRA is the result of more than a decade of Merck research in
neuroscience and provides tangible evidence of our long-standing
commitment to innovation.”

The FDA has recommended BELSOMRA be classified by the U.S. Drug
Enforcement Administration (DEA) as a scheduled product. Earlier this
year, the DEA proposed a Schedule IV drug classification under the
Controlled Substances Act. The DEA has not yet issued a final decision
on the scheduling for BELSOMRA and therefore product cannot become
available before that decision.

Indication for BELSOMRA

BELSOMRA (suvorexant) is indicated for the treatment of insomnia
characterized by difficulties with sleep onset and/or sleep maintenance.

Select safety information about BELSOMRA

BELSOMRA is contraindicated in patients with narcolepsy.

BELSOMRA can impair daytime wakefulness. Central nervous system (CNS)
depressant effects can last for up to several days after discontinuation.

BELSOMRA can impair driving skills and may increase the risk of falling
asleep while driving.

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. 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

The risk of next-day impairment, including impaired driving, is
increased if BELSOMRA is taken with less than a full night of sleep
remaining, if a higher than the recommended dose is taken, if
co-administered with other CNS depressants, or if co-administered with
other drugs that increase blood levels of BELSOMRA. Patients should be
cautioned against driving and other activities requiring complete mental
alertness if taken in these circumstances.

Caution patients taking 20 mg against next day driving and other
activities requiring full mental alertness.

Reevaluate patients for co-morbid conditions if insomnia persists after
7 to 10 days of treatments.

A variety of cognitive and behavioral changes (e.g., amnesia, anxiety,
hallucinations and other neuro-psychiatric symptoms) have been reported
to occur in association with the use of hypnotics such as BELSOMRA.
“Sleep driving” (i.e., driving while not fully awake) and other complex
behaviors (e.g., preparing and eating food, making phone calls, or
having sex), with amnesia for the event have been reported with the use
of hypnotics. These events can occur in hypnotic-naïve as well as in
hypnotic-experienced persons.

The use of alcohol and other CNS depressants may increase the risk of
such behaviors. Discontinuation of BELSOMRA should be strongly
considered for patients who report any complex sleep behavior.

In clinical studies, a dose-dependent increase in suicidal ideation was
observed in patients taking BELSOMRA, as assessed by questionnaire.
Immediately evaluate patients with suicidal ideation or any new onset
behavioral changes. Worsening depression or suicidal thinking, thoughts
and actions have been reported with the use of sedative-hypnotics.
Suicidal tendencies may be present in such patients and protective
measures may be required. Intentional overdose is more common in this
group of patients; therefore, the lowest number of tablets that is
feasible should be prescribed for the patient at any one time.

The effect of BELSOMRA on respiratory function should be considered.

The risk of sleep paralysis, hypnagogic/hypnopompic hallucinations and
cataplexy-like symptoms increases with increasing doses of BELSOMRA.

BELSOMRA is not recommended for patients with severe hepatic impairment
or those taking a strong CYP3A inhibitor.

In clinical studies the most common adverse reaction (reported in 5% or
more of patients treated with 15 or 20 mg of BELSOMRA and at least twice
the placebo rate) was somnolence (BELSOMRA 7%; placebo 3%).

The recommended dose of BELSOMRA is 5 mg in patients receiving moderate
CYP3A inhibitors.

Digoxin levels should be monitored closely as slight increases were seen
with co-administration of BELSOMRA.

BELSOMRA availability

BELSOMRA is expected to be available in late 2014 or early 2015.
Healthcare professionals and patients in the United States interested in
receiving an e-mail when BELSOMRA becomes available can register by
visiting www.belsomra.com.

About Merck

Today’s Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside the United States and Canada.
Through our prescription medicines, vaccines, biologic therapies, and
consumer care and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access to
healthcare through far-reaching policies, programs and partnerships. For
more information, visit www.merck.com
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The links below are to the FDA-approved labeling. Merck will not
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BELSOMRA® is a registered trademark of Merck
& Co., Inc., Whitehouse Station, N.J., USA

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