PAD - Prescribing Advisory Database
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 - Multiple sclerosis

Keywords :
sleepiness, fatigue, MS
Brand Names Include :
Provigil

Traffic Light Status

Status 1 of 1.

Status :
Red
Important
Formulations :
  • Tablets
Important Information :
Safety in pregnancy warnings.
Trust Alignment :
Primary Care
ASPH
RSFT
SASH
SABP
Links :
BNF NICE SPC
SA
Un
Comments :
No comments returned.
Documents :

Guidelines

No guidelines returned.

Other Drugs

Other Indications

Additional Documents

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.

Modafinil was added to the PAD for non-licensed indications in 2014, and the initial MHRA alert was taken into consideration when the decisions were made.  Feedback from specialists is to retain the option to use in the non-narcolepsy approved indications on PAD.  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 September 2014
Surrey & North West Sussex Area Prescribing Committee (formerly Prescribing Clinical Network)

Modafinil is not licensed for fatigue in MS. The PCN advised a RED traffic light status. There are a number of neurologists who may decide that modafinil is appropriate in a small cohort of patients in whom other treatments have been unsuccessful. In these circumstances, prescribing should remain with the specilaist.

Prescribe generically

Associated BNF Codes

04. Central Nervous System
04.04.00. CNS stimulants and drugs used for ADHD
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