The ACMD (Advisory Council on the Advisory Council on the Misuse of Drugs) and MHRA (Medicines and Healthcare products Regulatory Agency) has evaluated the risk of substance abuse and physical dependency of the medicine Sunosi (Solriamfetol). Sunosi is a once-daily prescription medicine used to improve wakefulness in adults with excessive daytime sleepiness due to obstructive sleep apnoea or narcolepsy.
What Does “Improved Wakefulness” Mean?
Improvements in wakefulness were determined by the Maintenance of Wakefulness Test (MWT).
The MWT is a standard test used to measure a person’s ability to stay awake during the daytime in a darkened, quiet environment. People are instructed to remain awake as long as possible throughout a series of 40-minute sessions that are spaced out across the day.
The MWT calculates the average time it takes for a person to fall asleep during each of these sessions. Individuals who have improvements in wakefulness are able to stay awake longer during the MWT.
Other Information You May Wish To Know About Sunosi
- Sunosi started working in as quickly as 1 hour in clinical studies at 12 weeks.
- Sunosi helped people stay awake for up to 9 hours in clinical studies at 12 weeks.
- Sunosi does not treat the cause of obstructive sleep apnoea or take the place of your CPAP.
- Do not take Sunosi if you are taking, or have stopped taking within the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).
- Sunosi is not a stimulant.
- Sunosi was not shown to cause symptoms of withdrawal or dependence in clinical studies.
- Sunosi is a controlled substance (POM) because it could be a target for abuse. Keep Sunosi in a safe place to protect it from theft.
- It is not known if Sunosi is safe and effective in children.
Important Safety Information
Do not take SUNOSI if you are taking, or have stopped taking within the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI). Before taking SUNOSI, tell your doctor about all of your medical conditions, including if you:
- Have heart problems, high blood pressure, kidney problems, diabetes, or high cholesterol.
- Have had a heart attack or a stroke.
- Have a history of mental health problems (including psychosis and bipolar disorders), or of drug or alcohol abuse or addiction.
- Are pregnant or planning to become pregnant. It is not known if SUNOSI will harm your unborn baby.
- Are breastfeeding or plan to breastfeed. It is not known if SUNOSI passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take SUNOSI.
Sunosi May Cause Serious Side Effects, Including:
- Decreased appetite
- Problems sleeping
These are not all the possible side effects of SUNOSI. Call your doctor for advice about side effects.
What The ACMD Said
The letter to Kit Malthouse MP recommends that the control of Sunosi, AKA Solriamfetol under the Misuse of Drugs Act 1971 is not required at this time. You can read the letter to MP Kit Malthouse from the ACMD below.