Merck’s Insomnia Medicine BELSOMRA® (suvorexant) C-IV, the First and Only Orexin Receptor Antagonist, Now Available in the United States


February 3, 2015 8:00 am ET

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that BELSOMRA® (suvorexant) is now available
at pharmacies in the United States for the treatment of insomnia in
adults who have difficulty falling asleep and/or staying asleep.
BELSOMRA is the only orexin receptor antagonist approved for the
treatment of insomnia in the United States. Orexin is one of the many
neurotransmitters in the brain involved in promoting wakefulness, and
BELSOMRA selectively blocks orexin receptors. In doing this, BELSOMRA is
thought to suppress wake drive in the brain.

“Insomnia is a serious condition that affects millions of Americans,”
said David Cloud, CEO of the National Sleep Foundation. “With BELSOMRA,
healthcare professionals and patients now have an additional option to

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.

BELSOMRA is contraindicated in patients with narcolepsy. BELSOMRA
contains suvorexant, a Schedule IV controlled substance. BELSOMRA can
impair daytime wakefulness. Central nervous system (CNS) depressant
effects can last for up to several days after discontinuation.

In the brain’s wake/sleep circuitry, two systems work together to
regulate wake and sleep. The system that is more active determines
whether a person is awake or asleep. The orexin signaling system is a
central promoter of wakefulness. Scientists currently at Tsukuba
University, Kanazawa University in Japan, and Stanford University in the
United States first discovered orexin in 1998.

“Merck has been conducting research in the sleep field for more than a
decade,” said Dr. David Michelson, vice president, Neurosciences, Merck
Research Laboratories. “We are proud to be one of the earliest companies
to research the role of orexin receptors in insomnia, which ultimately
led to the introduction of BELSOMRA in the United States.”

Patients with insomnia should ask their healthcare providers about
BELSOMRA. BELSOMRA is available in 5 mg, 10 mg, 15 mg, and 20 mg
tablets. Healthcare professionals and patients in the United States can
to learn more.

Merck is also developing a broad range of resources for patients to help
educate them about insomnia and encourage dialogue with their healthcare
providers. More information will be available in March 2015.

About Insomnia

Approximately 30 million Americans suffer from insomnia. People with
insomnia may have one or more sleep problems: difficulty falling asleep,
difficulty returning to sleep, and/or difficulty staying asleep.

Indication for BELSOMRA (suvorexant)

BELSOMRA 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 contains suvorexant, a Schedule IV controlled substance.

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

Coadministration with other CNS depressants increases the risk of CNS
depression. Patients should be advised not to consume alcohol in
combination with BELSOMRA due to additive effects. Dosage adjustments of
BELSOMRA and of other concomitant CNS depressants may be necessary when
administered together because of potentially additive effects. The use
of BELSOMRA (suvorexant) 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 recommended dose is taken, if coadministered
with other CNS depressants, or if coadministered 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.

Reevaluate patients for comorbid conditions if insomnia persists after 7
to 10 days of treatment.

A variety of cognitive and behavioral changes (eg, amnesia, anxiety,
hallucinations, and other neuropsychiatric symptoms) have been reported
with the use of hypnotics such as BELSOMRA. Complex behaviors such as
“sleep-driving” (ie, driving while not fully awake after taking a
hypnotic) and other complex behaviors (eg, preparing and eating food,
making phone calls, or having sex), with amnesia for the event, have
been reported in association with the use of hypnotics. Discontinuation
of BELSOMRA should be strongly considered for these patients. The use of
alcohol and other CNS depressants may increase the risk of such
behaviors. These events can occur in hypnotic-naïve as well as
hypnotic-experienced persons. 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. Suicidal tendencies may be present and intentional
overdose is more common in this group of patients. 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.

Sleep paralysis, hypnagogic/hypnopompic hallucinations, and
cataplexy-like symptoms can occur. The risk of cataplexy-like symptoms
increases with the dose 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 mg 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, as slight increases were seen with
coadministration of BELSOMRA (suvorexant).

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
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
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Forward-Looking Statement

This news release includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. These statements are based
upon the current beliefs and expectations of Merck’s management and are
subject to significant risks and uncertainties. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.

Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation in the
United States and internationally; global trends toward health care cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; Merck’s ability to accurately
predict future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign risk;
dependence on the effectiveness of Merck’s patents and other protections
for innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Additional factors that could cause results to differ
materially from those described in the forward-looking statements can be
found in Merck’s 2013 Annual Report on Form 10-K and the company’s other
filings with the Securities and Exchange Commission (SEC) available at
the SEC’s Internet site (

Please see Prescribing Information for BELSOMRA (suvorexant) at
and the Medication Guide for BELSOMRA at


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BELSOMRA® is a registered trademark of Merck
& Co., Inc., Whitehouse Station, N.J., USA

Merck & Co., Inc.
Pam Eisele, 267-305-3558
Megan Wilkinson, 267-305-6463
Justin Holko, 908-740-1879
Joe Romanelli, 908-740-1986

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