FDA-approved Medications for Narcolepsy



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FDA-approved Medications for Narcolepsy

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Narcolepsy Summary Report – FDA

www.fda.gov

There are five drug treatments approved to treat patients with narcolepsy: Xyrem (
sodium oxybate), Provigil (modafinil), Nuvigil (amodafonil), methylphenidate, and
amphetamine. There are no. FDA-approved drugs specifically for pediatric use in
treating narcolepsy. Other prescription drugs are also used off-label for …

PROVIGIL® (modafinil) Tablets – FDA

www.fda.gov

PROVIGIL is a prescription medicine used to improve wakefulness in adults who
are very sleepy due to one of the following diagnosed sleep disorders: •
narcolepsy. • obstructive sleep apnea (OSA). PROVIGIL is used to treat excessive
sleepiness, but not the obstruction or medical condition that is causing OSA. You
should …

MEDICATION GUIDE RITALIN – FDA

www.fda.gov

Read the Medication Guide that comes with RITALIN before you or your child
starts taking it and each time you get a refill. … The following have been reported
with use of methylphenidate hydrochloride and other stimulant medicines. 1. …
therapies. RITALIN is also used in the treatment of a sleep disorder called
narcolepsy.

Stimulant and Related Medications: Use in Adults – CMS.gov

www.cms.gov

Summarize the adverse reactions and risks of stimulant and related medications.
FDA-Approved Indications for Stimulant and Related Medications in Adults.
Stimulant and related medications are FDA approved for the treatment of ADHD,
narcolepsy, exogenous obesity. (a body mass index [BMI] of 30 or higher[1]), and
as …

PROVIGIL® (modafinil) – FDA

www.accessdata.fda.gov

FDA Approved Labeling dated August 17, 2007. PROVIGIL® …. enzyme
CYP2C19, co-administration of modafinil with drugs such as diazepam,
phenytoin and … Narcolepsy. The effectiveness of PROVIGIL in reducing the
excessive sleepiness (ES) associated with narcolepsy was established in two US
9-week, multicenter, …

Stimulant and Related Medications: U.S. Food and Drug … – CMS.gov

www.cms.gov

The FDA-approved dosages and indications for the use of stimulant and related
medications in adults are provided in this table. All medication doses listed are
for oral … be necessary to exceed a total of. 40 mg per day. Yes amphetamine/
dextroamphetamine mixed salts narcolepsy. Initial dose: 10 mg per day;. Usual
dose:.

Stimulant and Related Medications – CMS.gov

www.cms.gov

The FDA-approved dosages and indications for the use of stimulant and related
medications in adults are provided in this table. All medication doses listed are
for … Only in rare cases will it be necessary to exceed a total of 40 mg per day.
Yes amphetamine mixed salts. (Adderall®) narcolepsy. Initial dose: 10 mg per
day;.

Stimulant and Related Medications: Use in Pediatric … – CMS.gov

www.cms.gov

FDA-Approved Indications for Stimulant and Related Medications in Pediatric
Patients. Stimulant and related medications are FDA approved for the treatment
of ADHD, narcolepsy, and exogenous obesity (a body mass index [BMI] at or
above the 95th percentile for children of the same age and sex[1]) in pediatric
patients.

Stimulant and Related Medications: Use in Adults – CMS.gov

www.cms.gov

medications in adults. After reading this fact sheet, providers should be able to
accurately: • Identify the FDA-approved indications for the use of stimulant and
related medications in adults;. • Identify the available treatment options for
attention-deficit/hyperactivity disorder (ADHD) and narcolepsy in adults; and. •
Summarize …

Prescription Drug Benefits – NH Department of Administrative Services

das.nh.gov

Note: Certain medications, including many drugs prescribed for narcolepsy,
attention deficit disorder, and pain management, are mailed via expedited
delivery, and require a signature upon delivery. Back to top. Q: How are
medications shipped? A: Most medications are shipped via the U.S. Postal
Service at no cost to you.

ForwardHealth Update 2014-78 – January 2015 Preferred Drug List …

www.forwardhealth.wi.gov

Dec 1, 2014 PDL drug classes. For additional information about covered drugs on the PDL for
the BadgerCare Plus, Medicaid, and. SeniorCare, providers may refer …..
narcolepsy. (Note: Test results for the PSG and. MSLT, along with provider
interpretation, must be submitted with the PA request.) ✓ The member is not …

GAO-08-751 Food and Drug Administration: Approval and Oversight …

www.gao.gov

Aug 7, 2008 In September 2000, the Food and. Drug Administration (FDA), part of the
Department of Health and. Human Services (HHS), approved the drug Mifeprex
for use in terminating early term pregnancy. FDA approved the drug under a
provision of its Subpart H regulations, allowing it to restrict the drug's …

Prescription Drug Abuse in Indian Country – SAMHSA

www.samhsa.gov

Apr 8, 2014 Prescription Drug Abuse is a Significant. Problem in the United States. ▫
Prescription drugs are the … Most Commonly Abused Prescription Drugs. ▫
Stimulants. – Used to treat ADHD and narcolepsy ….. Opioid Brief Guide for
primary care physicians on how to use FDA-approved medications to treat opioid
 …

Preferred Drug List (PDL) – Department of Vermont Health Access

dvha.vermont.gov

Jan 1, 2015 The therapeutic classes of drugs which have clinical criteria for Prior
Authorization may or may not be subject to a preferred agent. …..
Dexmethylphenidate and Focalin: patient has a diagnosis of ADD, ADHD or
narcolepsy AND patient has been started and stabilized on the requested
medication.

Prescription Drug Abuse – National Institute on Drug Abuse

www.drugabuse.gov

The nonmedical use and abuse of prescription drugs is a serious public health
problem in this country. Although most people take prescription medications
responsibly, an estimated 52 million people (20 percent of those aged 12 and
older) have used prescription drugs for nonmedical reasons at least once in their
lifetimes …

Misuse of Prescription Drugs – cloudfront.net

www.drugabuse.gov

Summary. What is the scope of prescription drug misuse? How many people
suffer adverse health consequences from misuse of prescription drugs? Is it safe
to use ….. hyperactivity disorder (ADHD), narcolepsy, and occasionally treatment
….. At this time, there are no FDA-approved medications for treating addiction.

Prescription Drug Abuse – NIDA for Teens – National Institute on …

teens.drugabuse.gov

The nonmedical use and abuse of prescription drugs is a serious public health
problem in this country. Although most people take prescription medications
responsibly, an estimated 52 million people (20 percent of those aged 12 and
older) have used prescription drugs for nonmedical reasons at least once in their
lifetimes …

1 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN …

www.justice.gov

Provigil. 10. In 1998, the FDA approved Provigil to treat excessive daytime
sleepiness associated with narcolepsy. In 2004, the FDA approved the
expansion of Provigil's label to include the treatment of excessive sleepiness
associated with obstructive sleep apnea/hypopnea syndrome, and shift work
sleep disorder. 11.