PAD Profile : Modafinil - Narcolepsy

PLEASE NOTE : This is a development system.

For Surrey PAD, please go to https://surreyccg.res-systems.net/PAD.

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PAD Profile : Modafinil - Narcolepsy Important

Keywords :

sleepiness, fatigue

Brand Names Include :

Provigil

Important Information :

Pregnancy safety warnings.

Traffic Light Status

Status 1 of 1.

Status :

Amber

Formulations :

Tablets

Trust Alignment :

Primary Care

ASPH

RSFT

SASH

SABP

Links :

BNF NICE SPC

Comments :

No comments returned.

Documents :

Guidelines

No guidelines returned.

Other Drugs

Other Indications

Additional Documents

Type

Document

Review Date

Shared Care

Modafinil for Narcolepsy - Amber Shared Care - PCN November 2014

31 March 2020

Shared Care

Modafinil for Narcolepsy - Amber Shared Care ESHUT - PCN November 2014

31 March 2020

Evidence Review

Modafinil - Evidence Review - Jul 2014

Webpage

Modafinil (Provigil): increased risk of congenital malformations if used during pregnancy - MHRA

06 August 2025

Committee Recommendations

Date

Committee Name

Narrative

09 August 2023

Surrey Heartlands Medicines Safety Committee (MSC)

The MHRA published in the Drug Safety Update (Dec 2014, updated November 2020) an update on the safety of modafinil, in regard to its effect on unborn children. Modafinil potentially increases the risk of congenital malformations when used in pregnancy.

Modafinil should not be used during pregnancy and women of childbearing potential must use effective contraception during treatment and for 2 months after stopping modafinil.

See link to the MHRA information for further information https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/936767/Nov-2020-DSU-PDF-1.pdf

03 May 2017

Surrey & North West Sussex Area Prescribing Committee (formerly Prescribing Clinical Network)

GENERIC Modafinil has been considered by the PCN and has been assigned a AMBER traffic light status NOTE - the branded product, Provigil, was considered BLACK at the PCN in May 2017.

03 September 2014

Surrey & North West Sussex Area Prescribing Committee (formerly Prescribing Clinical Network)

Modafinil is only licensed for narcolepsy (with or without cataplexy). Agreed as Amber (suitable for shared care). Shared Care Agreement under development. Modafinil for any other unlicensed indication was granted a RED traffic light status.

Associated BNF Codes

04. Central Nervous System

04.04.00. CNS stimulants and drugs used for ADHD