Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

BELSOMRA (NDA-204569)

(SUVOREXANT)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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03/25/2021 (SUPPL-8)

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

03/18/2020 (SUPPL-7)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

(Additions and/or revisions underlined)

Cardiac disorders: palpitations, tachycardia

Nervous system disorders: psychomotor hyperactivity

Psychiatric disorders: anxiety

Skin and subcutaneous tissue disorders: pruritus

01/29/2020 (SUPPL-6)

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)].

07/12/2018 (SUPPL-5)

Approved Drug Label (PDF)

6 Adverse Reactions

Newly created subsection:

6.2 Post-Marketing Experience

Cardiac disorders: palpitations, tachycardia

Nervous system disorders: psychomotor hyperactivity

Psychiatric disorders: anxiety

05/27/2016 (SUPPL-4)

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MG - The following additional side effects have been reported with BELSOMRA:

abnormal dreams